PowerPoint Template - Online GMP Training

Auditor Training

Presented by Maria Mylonas2020

© PharmOut 2020

About PharmOut

• PharmOut is a rapidly growing international consultancy offering GMP compliance, qualification & validation, TGA regulatory, engineering and architectural consulting services to the pharmaceutical, blood & tissue, pesticides and veterinary and medical device manufacturers, as well as related hospital and pharmacy operations.

• PharmOut holds ISO 9001:2015 certification from LRQA. Our Quality Management System is certified to the ISO 9001:2015 standard for the provision of architectural design and consultancy services.

"Regulatory Knowledge, Practically Applied"

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Activity - Introductions

• Who are you? Introduce yourself.

• What is your position?

• Which industry are you from?

• How long have you worked in a regulated environment?

• Why are you here today?

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Course Agenda

01 Introduction

02 Types of inspections

03 The art of inspecting

04 Communication styles

05 Difficult behaviour

06 Risk-Based Inspections

07 Managing the audit program

08 Audit trends and findings

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Course Assessment – Online GMP

At the end of the training you will complete an online assessment through www.onlinegmptraining.com:

• You have 60 days access to complete the assessment and evaluation and download materials.

• The assessment is ‘open book’

• The assessment will take Approximately 10 minutes and you will get your certificate

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Virtual Training Guidelines

Module 1: Introduction

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ISO13485 – Medical Device

Measurement, analysis and improvement8.2.4 Internal audit

The organization shall conduct internal audits at planned intervals to determine whether the quality management system:

a) conforms to planned and documented arrangements, requirements of this International Standard, quality management system requirements established by the organization, and applicable regulatory requirements;

b) is effectively implemented and maintained.

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PIC/S GMP – Medicinal Products and APIs

PIC/S PE 009 Part I Chapter 9PIC/S PE 009 Part II Section 2.5

Self inspections should be conducted in order to monitor the implementation and compliance with Good Manufacturing Practice principles and to propose necessary corrective measures.

Guide to GMP, PE 009-13 (2017)

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Chapter 9: Self Inspection

Scope• Personnel matters• Premises• Equipment• Documentation• Production• Quality control• Distribution of product• Complaints and recall

process• Self-inspection process

Self inspections must be conducted by an

independent person from the company or external

experts

Self-inspections must be recorded with observations and proposals for corrective actions. Subsequent actions

must also be recorded.

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APVMA – Code of GMP

Chapter 10 – Internal Audits• Manufacturers of veterinary chemical products must regularly and systematically

carry out internal audits of all aspects of their manufacturing operations, as well as of their quality assurance program, in order to monitor compliance with their authorised procedures, standards and requirements and ensure product quality.

• Steps must be taken to implement any necessary corrective and preventive action identified by those internal audits and to assess the outcomes.

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Australian Code of GMP – B &T

Quality ManagementMeasurement and monitoring

109. A program for self-inspection should be established, documented and implemented to periodically assess the effectiveness of the quality system. 110. Selection of auditors and conduct of self-inspections should ensure objectivity and impartiality. Auditors should not audit their own work. 111. Self-inspections should be recorded. Reports should include observations made during the inspections and, where applicable, proposals for corrective measures. Records of the subsequent actions should be maintained. 112. There should be procedures for the ongoing management and review of the corrective actions to ensure timely and effective implementation.

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Self-Inspection

Lets have a group discussion on self-inspection.

• Describe the process of self-inspection that you follow.

• How do you handle the corrective measures?

Background to GMP

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What is GMP?

The acronym GMP is used internationally to describe a set of principles and procedures which, when followed by manufacturers of therapeutic goods, helps ensure that the products manufactured will have the required quality.

A basic principle of GMP is that quality cannot be tested into a batch of product but must be built into each batch of product during all stages of the manufacturing process.

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What does “quality” mean?

• What does quality mean?

• What do you expect from a quality product?

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Its 1989. It’s a drug packaging room.

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Its 2017 –It’s an Under Testing Area????

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Its 2020

Global Regulations

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Global Regulators

HCMHRAHPRA

CFDA

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54 PIC/S member authorities

4 Partners

EDQMEMA

UNICEFWHO

New Zealand

Iceland

Canada

USA

Argentina

South Africa

Australia

Malaysia

Taiwan

Switzerland

Norway

Indonesia

Ukraine

Singapore

IsraelLiechtenstein

EUROPEAN UNION Member States Agencies (29)

Japan

South Korea

Hong Kong

Thailand

Mexico

Iran

Turkey

Greenland

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There is ISO…

ISO (International Organization for Standardization) is the world’s largest developer of voluntary international standards. ISO is used by many industries, not just pharmaceuticals.

• http://www.iso.org/iso/home/

Developed through global consensus, they help to define global quality standards.

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ISO standards

ISO has developed more than 19,000 standards.

Your policies may be aligned with some of the following ISO standards:

• ISO 13485: Medical Devices • ISO 9001: Quality Management

Systems • ISO 14644: Cleanrooms and

associated environments

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What or who is ICH?

• The International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) includes the regulatory authorities of Europe, Japan and the US and experts in these regions to discuss scientific and technical aspects of pharmaceutical product registration.

• ICH Guidelines aren’t law but are regarded as ‘best practice’ by regulators.http://www.ich.org/

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Regulators have the power to:

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Importance of GMP

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What’s in it for me?

Successfully implementing the regulations, following policies and undergoing successful audits has a strong incentive for manufacturers and employees.

Quality Job Security

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Laying the foundations

• Understanding the principles of GMP is the foundationof implementing quality in the workplace.

• If we understand the ‘why’, the ‘what’ is easier to implement.

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Activity 1: GMP – Ten Golden Rules

Rule 1• Ensure productivity, product quality, and employee

health and safety are included in the design and construction of all facilities and equipment.

Rule 2• Ensure that systems achieve what they are designed

to do by validating facilities, equipment and processes.

Rule 3• Prepare detailed procedures that provide a step-by

step road-map to control and maintain consistent performance

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Rule 4• Follow written procedures in order to prevent

contamination, mix-ups and errors

Rule 5• Accurately record actual process events, in real time,

for compliance and traceability

Rule 6• Create clearly defined responsibilities, and ensure the

development and demonstration of job competence

Rule 7• Protect against contamination by ensuring cleanliness

is at the forefront of all employees’ daily routines

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Rule 8• Ensure all facilities and equipment are properly maintained

Rule 9• Build quality into products by controlling product components

and product related processes such as manufacturing, testing, packing and labelling, and distribution

Rule 10• Install planned and regular audits to ensure achievement of

compliance and performance

Module 2: Types of Audits

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Type of Audits

1st Party Audit

• Self-Inspection (Internal) Audit

2nd Party Audit

• External provider audit• Other interested party audit

3rd Party Audit

• Certification and/or accreditation audit

• Statutory, regulatory and similar audit

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Self Inspections/ Internal Audits

• It is a requirement to establish, implement and maintain your QMS.

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• Performed in-house most often by a team and involve people with different expertise

• Could be carried out within a single facility or organised by Head Office to be done over a range of facilities

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Departmental Self Inspections

Periodic self inspections, restricted to a department or a functional unit

Usually done by the area manager/ supervisor with assistance from a different department

Checklists

Results are confined to the audited area

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Site Self Inspections

More detailed inspections

Use of audit plans and aide memoirs beneficial

Identify inter-departmental issues and provide good understanding of compliance

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Corporate Self Inspections

Generally compliance and corporate governance focussed

May encounter some difficulties due to different regulations

Audit report is provided to top management

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Self Inspections done by external experts

Could be full self audit of a facility or system specific audit

External expertise, a fresh set of eyes

No politics

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External Audits – Regulatory Audits

• Carried out by national auditing/ inspecting authorities

• Verify compliance with the ISO Standards and other national legal requirements

• Could be product specific or system audits• Could be triggered by a product recall or

other undesired events (unannounced?)• Detailed in scope

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External Audits –Due Diligence (pre-contract)

• Carried out prior to entering into contract manufacture

• Determine manufacturer’s capability to manufacture a product

• Limited in scope • Are a basis to develop good relationship

between contract giver and acceptor

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External Audits –Contractor Audits

• Carried out to determine manufacturer’s technical capability

• Carried out by a group of experts from contract giver

• Establish line of communications and priorities between involved parties

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External Audits –Supplier Audits

• Carried out on suppliers of critical raw materials and packaging materials

• Verify materials specifications• Could be used to justify reduced raw

materials testing

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External Audits –Supplier Audits

• Geographical constraints

• Cursory QMS compliance and desk top audit

• Remediation of previous quality issues associated with a supplier

Module 3: The art of self inspection / auditing

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Introduction

The success of an inspection ultimately depends on the abilities

of the auditor or inspector.

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Introduction

The inspector holds a lot of power as the inspection outcomes may impact significantly on the inspected manufacturer business.

How the inspector chooses to use that power is often reflected in his/ her attitude and is likely impact the inspect outcomes.

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Inspector attributes

• Knowledgeable

• Being able to identify and focus on areas of high risk

• Being well trained in inspecting

• Having appropriate personal skills

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Activity 2: Inspector attributes

• In your small groups, list:• Desirable characteristics / mind-set• Undesirable characteristics /mind-set

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Desirable personal characteristics/ abilities:

Honest and unbiased Diplomatic Self

disciplined

Able to communicate with clarity

Able to communicate at any level

Good listener/ interested/

patient

Good analytical

skillsObservant Resilient/ firm

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Desirable attitude/ mind set:

• I am a guest

• Achieve rapport and earn respect

• Overcome fear

• They should be the experts not me

• I am a catalyst for improvement

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Desirable attitude/ mind set:

• Analyse the systems not the people

• I will demonstrate respect

• I will acknowledge things well done

• I always strive for “win : win” situation

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Undesirable characteristics:

I am the authority...

demand respectI know best... I

am the inspector I win, they loseMore

deficiencies, better inspect

Find someone to blame Them and us...

I am here to enforce best

practice

No time to be nice and

understanding

Satisfaction from inspection report full of bad news

Good inspectors have “bad reputation”

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Conducting an inspection

We are all different and this will result in differences in inspection styles

We have different knowledge and experience and this will result in a different depth of inspection

An understanding of what an inspection is expected to achieve should help to limit variability

Consistency must be managed

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The art of inspecting

There are 4 simple words that describe the way inspections should be conducted…..

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Fair

Firm

Friendly

Thorough

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An inspection conducted by a knowledgeable inspector that is fair and thorough, and is conducted in a firm and friendly manner, is a “good” inspection

The number of deficiencies doesn’t define a “good” inspection!

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Fair - objectivity

• No personal opinions

• Stick to the GMP Guide and Regulations

• If you can’t explain a deficiency in terms of – “the GMP Guide requires …………. –you are not meeting this requirement in that ……………”, it probably isn’t a deficiency

• It’s not what we think the manufacturer or supplier should be doing – it’s what the GMP Guide or Regulations require

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Fair - balance

• If something is good, say so

• If something is just OK, say so and suggest that it be improved

• If it is just OK, it isn’t a deficiency, but could be commented on in the inspection report

• At the exit meeting comment on the strengths and weaknesses

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Fair - transparency

• Let the company know what is planned

• Potential deficiencies must be explained at the time they are observed

• Provide feedback on how the inspection is going

• All deficiencies must be discussed at the exit meeting

• Allow reasonable time for discussion – don’t jump to conclusions• It’s OK to back down if appropriate

• If you’re not sure, say so and that you’ll discuss it at the office and get back to them

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Fair – be constructive

• Be open to discuss options for correction, but don’t go too far

• Consulting must be avoided –very strict on this

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Fair – don’t be petty

• If there is a very minor one-off slip-up, don’t record it as a deficiency.

• Expect correction and possibly mention it in the inspection report.

• It’s the systemic failures that are the real risk factors – pettiness distracts from this.

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Fair

Deficiency corrected during the inspection

• It is still an observation that should be reported as a deficiency (explain this)

• Be open to reviewing what has been done

• Indicate after the deficiency – “corrected during the inspection – response not required”

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Fair – risk management

• Focus on activities that may significantly impact on product quality

• Consider observations in terms of consequence and likelihood – not absolute worst case• Classify deficiencies correctly

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Fair

Start and finish at reasonable times and take reasonable breaks

• As far as possible fit in with normal working hours

• The factory staff may need a break even if you don’t

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Fair

• Don’t extend the company’s resources to the point that responses to questions may be compromised

• Especially for team inspections

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Firm

Inspectors, not manufacturers, decide what is going to be done and when:

• The inspection plan is a guide only

• Be flexible - change the plan if there is good reason to do so and it makes little or no difference

• Cover everything in an area while there. Don’t go backwards and forwards

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Firm

• If you ask for something, follow through and insist

• Clarify and remind - if still not produced, it becomes a deficiency

• Don’t be distracted

• Reasonable discussion about GMP is OK to be helpful

• If it’s clearly a deficiency, it’s a deficiency!

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Firm

Being firm doesn’t mean being unfriendly!

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Friendly

There is nothing to be gained by conducting an inspection in an unfriendly atmosphere

• Actively try and establish a friendly atmosphere

• Inspectors can set the tone of an inspection

• Staff open up and involve themselves in the inspection process • Better cooperation will lead to an efficient inspection.

• More likely to discover what really goes on

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Friendly

• Be courteous• Show respect• Be pleasant• Be calm and confident• Be humble

At all times:

• Do not discuss religion, politics etc.• Stories about family, holidays etc. usually not

appropriateDon’t overdo it:

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Friendly

• Never, even if provoked:

• Be aggressive• Get angry• Be rude• Get personal• Use bad language• Gloat or “point score”

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Friendly

• At all times:

• Keep calm and composed!

• Try and defuse tense situations

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Thorough

We have to accept that time is always limited:

A short inspection can be thorough• Just plan to do

less and do this thoroughly

Manage time on a risk basis

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Thorough

We have to accept that time is always limited:

Don’t spend a long time on less important things if there isn’t time. For example:• A short time in the warehouse is often enough• Document control can be assessed throughout the

inspection• Look for key elements in an SOP - verify by

questioning

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Thorough – time management

• The inspection plan should allocate time on a risk basis

• Be flexible and manage the unexpected

• Review and revise the plan as necessary – communicate

• Stay focussed and keep moving

• Don’t waste time pursuing trivia

• Once compliance or non-compliance has been established, move on

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Thorough

Horizontal vs vertical inspection

• We have to cover as much as possible in the time allocated

• Skimming the surface in a purely horizontal inspection is not acceptable

• Be prudent in deciding when to dig deeper and how deep to dig• A must for critical elements• For minor things, dig to next level - if OK, move on

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Thorough

• Critical elements should never be left out

• Note in the inspection report “not covered” or “briefly covered”• The next inspection should cover these properly

If time runs out, it is OK if a few minor elements are not covered:

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FFFT Inspections

Fair

Firm

Friendly

Thorough

You are expected to conduct thorough inspections in a fair, firm and friendly manner.

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Activity 3: Preparing for a self inspection

Open your workbook

• Outline how you would go about preparing and conducting a self inspection in your chosen department

• Present to the group

Workbook:

Module 4: Communication Styles

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Effective Communication

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Effective communication is the greatest quality of every inspector!

• Learnt skills alone are insufficient

• Other qualities are essential

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3 qualities/ attitudes of effective communicators:

Genuineness Completeness Empathy

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• is to be honest and open about ones feelings, needs, ideasTo be genuine:

• the receiver gets all the information needed to process the message and take action

To be complete:

• to be able to see and hear another person from their perspectiveTo be empathetic:

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To be an effective inspector means:

Knowing how to use soft skills and non-verbal communication

Knowing how to ask questions

Knowing how to listen

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Use of soft skills and non-verbal communication

Establishing Rapport• Try not to behave too official• Explain your task• Give space and “permission” to speak

You can control (to a level) how people feel and respond when being interviewed

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Questioning Styles

There are several type of questioning styles experienced inspectors use during the inspection to:

initiate conversation

obtain information

verify information

test the level of knowledge

get acceptance of inspection findings

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Questioning StylesQuestioning Style Example

Closed This is used to narrow the context and establish a point of fact. It is also a good type of question to open up. Are you responsible for… data entry?

Open Relaxes and instils some confidence in responding person. Encourages/gives permission to talk.

Tell me … how samples are logged into laboratory?

Probing Allows to probe very deeply into a critical subject matter.

What sort of impact do you think…? How did you decide…? How did you determine…?

Hypothetical Allow to assess their knowledge of procedures, level of controls.

What would you do if … samples tested out of spec?

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Questioning StylesQuestioning Style Example

Leading This is used to get acceptance (of an observation, or a deficiency). I suppose that you are going to … change the procedure to reflect how samples are logged?

Reflective Allows the communication of feelings.

How do you feel about the current process?

Paraphrase Checks for understanding.

From what you have told me… while the procedure was said to be followed an error was made in that step 5 was conducted before step 4. Is my understanding correct?

Clarifying When you need more information.Start with AND - And after you have entered the data what happened next?

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Activity 4: Questioning Styles

Closed Open Probing

Hypothetical Leading Reflective

Paraphrase Clarifying

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Active Listening

• Look at the person talking to you

• It is OK to take brief notes (write more later)

• Nod your head to show that you are listening

• Focus on person train of thoughts, NOT on your next questions

• If there is a gap, don’t rush and ask another question

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Competitive Listening

You have your own idea how things should be done or what has happened instead of listening what someone is saying.

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Passive Listening

Not paraphrasing the answers

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Active Listening – use it!

Remember: make an effort to let people know that you are listening

Engage yourself

Encourage the person by

body signs

Confirm that the message is understood

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Active Listening

Use different types of communication to achieve results:

Always remain in

the“here and

now”

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Investigation Rules

Use systematic doubt and...question everything

Recognise the difference between rational proof and... persuasion

Be precise in the use of words and demand the same from others

Pay specific attention to “unusual events”

Always watch for errors... in every system of controls, in every document, record reviewed

Module 5: Dealing with difficult behaviour

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Dealing with Difficult Behaviour

The Auditor may encounter from time to time defensive behaviour and have to be able to recognise the behaviour, identify the real reasons behind it and handle it appropriately.

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Low reactions

• Feared by most experienced auditors

• Reaction to the topic

• Behaviour that is most difficult to deal with

• Little information provided on how someone feels about the issue under discussion

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Low reactions

A Low Reactor spends less than 10% of their time supporting; disagreeing and defending or attacking.

They may actually say a lot but do not express their opinion.

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Low Reactions: Normal Response

Distinct feeling of discomfort

Concern about how to get through the individual

Feeling of hostility which gradually increases

Lessening self confidence

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Low Reactions: Traps

• Talking faster or drying up completely• Becoming agitated and not being able to argue our case• Repeating ourselves• Asking fewer questions (inhibition)• Exaggerating or making things up to get a response

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Dealing with Low Reactors

• Identify lack of response/ falling into a trap

Recognise what is happening

• Do not imagine objections or resistance which is not there

Maintain sense of perspective

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Dealing with Low Reactors

Ask questions• Rephrase if necessary

until you get a useful response

Avoid repetition• If you sure they have

heard, follow with silence as they may be considering the point

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Anger

• Anger is quite a common defensive response

• To cope with it effectively the auditor must understand what part it plays in behaviour and distinguish it from aggression

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Understanding Anger

• Anger is a natural psychological and physical experience

• Anger warns us that we or our circle of concern are under threat

• Anger provides us with energy and power to defend ourselves

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Understanding Anger

• Some people were taught that it is undesirable to express anger. • This can lead to frustration and silent resentment, as there is no way to

express feelings. • Interviews can become very tense.

• Other people were encouraged to express their anger and found out that it helps them to get their way. • These people may become aggressive.

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Dealing with Anger

• Angry people are unlikely to listen well or be rational, therefore:

Listen well (not easy)

Clarify what the person is saying

Do not argue back

Do not try to be too rational

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Dealing with Anger

Acknowledge the anger (yes I can see that your are angry)

Recognise if you are getting angry

State your points assertively

Try to solve problem involving the other person

Never say something which make the matter worse

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Anger and Aggression

While anger is a natural emotion, aggression is a style of behaviour, therefore aggression is directed at control and defending territory.

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Aggression may benefit an individual by:

Winning at the expense of others

Controlling others

Creating an image of power

Devaluing the competence of others (auditor’s?)

Reducing the number and direction of questions

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Clues for an interview:

Is aggression expressed

because of lack of self esteem? or

because someone is trying to project

the image of power?

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Expression of Aggression

• Overtly aggressive behaviour shows as:

Strength Volume Body language

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Expression of Aggression

• Indirect aggression is much harder to deal with as difficult to recognise it for what it is – an equally strong bid to control others.

• Expressed in people who have difficulty with dealing with a conflict and may lead to manipulations.

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Manipulation

People who don’t like what we are saying may try an indirect manipulative response.

• For example, trivialise us or our case.

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Guilt

Guilt could be a formidable weapon in capable hands. We are encouraged to believe that we are making life unnecessarily difficult for someone or perhaps not treating them fairly.

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Irrelevant logic

Irrelevant logic is used to distract us from our objective.

The other party introduces arguments that sound convincing but, in fact, are irrelevant.

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Effective Verbal Strategies

• Our first response when dealing with difficult behaviour is to react. • When attacked, we bite back or retreat. • These reactions reinforce the other person’s behaviour.

Control initial reaction

Understand the other person’s

behaviour Respond

appropriately

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Developing objectivity

When faced with difficult behaviour:• Detach yourself emotionally• Take few steps back• Look at the situation from a distance

You will see more clearly what is happening

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Defusing Defensiveness

Try to get behind the other person’s defensiveness

Acknowledge their feelings

Paraphrase what they say and check you have understood

Agree where you can (it is natural to focus on differences)

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Defusing Defensiveness

• Do not use the word “but”. Say “yes and ...” Stipulate discussion.• Make “I” statements rather than “You” statements.

Stand up for yourself

Put your view clear

Use assertive behaviour

Module 6: Risk-based inspections

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Introduction

• Risk management principles can be applied to all aspects of inspections

• Scheduling• Planning• Performing• Report writing

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Applying Risk Management (RM)

Applying RM principles during audit planning and execution is essential.

During an audit we assess risk in terms of threat to the patient and to the company.

The time devoted to any activity during an audit should be commensurate to the risk associated with the activity.

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Scheduling inspections

• There are 3 main types of regulatory inspections

Initial Special Routine

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Initial inspection

The first inspection of a new manufacturer or first inspection of a new facility of an existing manufacturer.

Normally conducted to determine GMP compliance for the purpose of licence issue.

All initial inspections are full inspections.

No risk because manufacture hasn’t started

Need to be scheduled as soon as possible because manufacturer is waiting

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Special inspection

An unscheduled inspection conducted for a special reason

• e.g. to investigate a complaint, recall or product failure, follow up specific areas of concern that may exist at a company.

Usually there is an existing risk, but magnitude may not be known – the reason for the inspection.

Because of the risk, need to be scheduled as soon as possible

• Timing depends on situation• Usually need to be given priority• May need to be done immediately.

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Routine inspections

• Regular on-going inspections of licenced manufacturers to verify continuing GMP compliance and eligibility to hold a manufacturing licence.

• Normally are full inspections.• For very large sites could be a series of rolling inspections

• There is always a residual risk, but this was determined to be acceptable at last inspection.• Confidence in the risk being acceptable diminishes with time• Regular re-inspections are necessary• Frequency depends on a number of risk factors

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Routine inspection frequency

Schedule on a risk basis, taking into account all known factors that could affect quality, safety and efficacy, including:

type of product(s) manufactured and nature of activities1results of previous GMP inspections2recalls or complaints since last inspection3results of product testing4significant changes within the manufacturer, eg. changes to key personnel, buildings, equipment, products etc.5any other relevant information6

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TGA: risk-based approach to frequency

• Employ a risk-based approach to the frequency of manufacturer inspections. • Inspection frequency matrices are used to guide the frequency of inspections. • In planning the inspection program, they also take into account:

• emerging trends• recalls• adverse events• results of laboratory testing• feedback and inspections undertaken by other regulators

https://www.tga.gov.au/manufacturer-inspections-risk-based-approach-frequency

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• In planning the inspection program, they also take into account:• compliance history• significant changes within the company, including:• key personnel appointments or resignations• building• key equipment• product lines• intention to cease business.


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This information is collated in the Manufacturer Profile, which may be updated at any time to reflect recent events or changes to risk factors.

Where necessary, an unannounced inspection may be undertaken at any time outside of the regular inspection cycle, or the date of the next scheduled inspection may be brought forward.


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• TGA recognize that manufacturers with a history of high level compliance, as evidenced by repeat A1 inspection ratings, do not need to be inspected as frequently as other manufacturers.

• Their reinspection frequencies therefore include extended reinspection frequencies and reduced inspection scope (i.e. shorter inspections) for such manufacturers.

• It is important to note that extended reinspection frequencies and reduced inspection scopes will no longer apply if a manufacturer with a history of A1 inspection ratings receives an A2 or A3 rating.


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• In planning the next inspection of a manufacturer the TGA does take into account the number of deficiencies identified at the previous inspection.

• This is to allow inspectors sufficient time to assess the corrective and preventive actions taken by the manufacturer to address the issues.

• For example, the TGA anticipates that a reinspection of a manufacturer that achieved an A2 rating may require an additional half day at the next inspection, whereas an additional full day may be required where the previous inspection resulted in an A3 rating.

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In cases where there are compliance concerns the TGA will continue to apply their full suite of regulatory tools, including unannounced inspections, close out inspections and bringing forward planned inspections, to protect the health and safety of Australian consumers.

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Listed Medicines


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Registered medicines and blood, tissue and cellular therapies


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Inspection duration

• Sufficient time must be allowed for a thorough risk-based inspection.

• Several factors must be considered when deciding inspection duration. For example:• size of manufacturer • types of products manufactured, number of products

manufactured • compliance history• composition of inspection team.

• Depending on these factors, inspection duration may vary from 1 day to 5 days.

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Inspection preparation

• Good preparation is essential.• Inspection preparation should include (as relevant) a review of:

Site Master File

at least the last two inspection reports, close-

out records and associated correspondence from

company, including CAPAs

licence application (if applicable)

manufacturing licence and conditions

any complaints, recalls or results of any analytical

testing

products registered – print data for a representative

range of products to check against manufacturing

records

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Inspection planning

The benefits of planning:

Good preparation allows you to start the inspection smoothly in professional manner.

Being well prepared allows you to concentrate on the important and high risk areas.

You will be organised and relaxed during the inspection.

Ensures that nothing will be missed.

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Applying risk management to inspection planning

It is impossible to look at everything during an audit in a given time

An audit is a sampling exercise and therefore an auditor should know where to sample and how much sample

Effort (time) should be consistent with potential risks

Module 7: Managing an Audit Program (ISO 19011)

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Audit program

• An audit program should reflect the size, nature and complexity of the organisation

• Top management should nominate someone to manage the audit program (audit program manager)

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Management of an audit programme

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PlanDo

CheckAct

5.2 Establishing the audit programme objectives

5.4 Establishing the audit programme

5.5 Implementing audit programme

5.6 Monitoring the audit programme

5.7 Reviewing and improving the audit programme

Competence and evaluation of auditors (Clause 7)

Conducting an audit (Clause 6)

5.3 Determining and evaluating audit programme risks and opportunities

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Why is planning so crucial to a successful audit?

Planning is a key to audit success.

If you fail to plan an audit, you plan to fail.

PlanDo

CheckAct

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The benefits of planning

Good preparation allows you to start the audit smoothly in professional manner

Good preparation shows that you are taking it seriously

Involving the auditee builds positive working relationship

PlanDo

CheckAct

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The benefits of planning

Being well prepared allows you to concentrate on the important and high risk

Being well prepared means there will be little of surprises

You will be relaxed during the audit

PlanDo

CheckAct

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5.2 Establishing audit programme objectives

Objectives should be consistent with and support management system policy and objectives, based on:

o Results of previous auditso Risks to auditeeoManagement prioritiesoManagement system requirements

PlanDo

CheckAct

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Establish the audit program - objectives

• Examples:• to meet requirements for certification to a

standard• to verify conformance with contractual

requirements• to obtain and maintain confidence in the

capability of a supplier• to continue to improve the management

system.

PlanDo

CheckAct

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Objectives: Plan

PlanDo

CheckAct


The individual managing the audit programme should identify and present the risks and opportunities considered when developing the audit programme and resource requirements so that they can be addressed appropriately.


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5.3 Determining and evaluating audit programme risks and opportunities Plan

DoCheck

Act5.3 Determining and evaluating audit programme

risks and opportunities - Risks

Planning: Failure to determined extent and

number of auditors

Planning: Failure to set objectives, duration,

location, schedule of the audit

Resources: insufficient time/equipment/ training

for the developing the audit programme or conducting the audit

Audit team selection: insufficient overall

competence to conduct the audit effectively

Communication: ineffective internal/

external communication processes/ channels

Implementation: ineffective coordination or

not considering information security and

confidentiality

Control of documented information: ineffective documented information ,

failure to adequately protect audit records to

demonstrate audit program

Monitoring, reviewing and improving

programme: ineffective monitoring of audit

programme outcomes

Availability and cooperation of auditee

and availability of evidence to be sampled

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5.3 Determining and evaluating audit programme risks and opportunities Plan

DoCheck

Act5.3 Determining and evaluating audit programme

risks and opportunities - Opportunities

Allowing multiple audits to be conducted in a

single visitMinimizing time and

distances travelling to site

Matching level of competence of the audit

team to the level of competence needed to

achieve the audit objectives

Aligning audit dates with the availability of auditee’s key staff

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Objectives: Plan

PlanDo

CheckAct


5.4.1 Roles and responsibilities of the person managing the audit programme

5.4.2 Competence of the person managing the audit programme

5.4.3 Establishing the extent of the audit programme5.4.4 Identifying audit programme resources



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PlanDo

CheckAct

5.4.1 Roles and responsibilities of the person managing the audit programme

Establish extent of the programme

Identify and evaluate risks

Establish audit responsibilities

Establish audit procedures

Determine resources

Ensure implementation

Ensure maintenance of

records

Monitor and review the programme

Keep top management

informed

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The person managing the audit should have the necessary competence to manage the programme and its associated risks.Key knowledge includes:• Audit principles, procedures and methods• Management systems standards and reference/

guidance documents• Auditee context of organisation (external/internal

issues, interested parties, business activities, products, services and processes)

• Applicable statutory and regulatory requirements relevant to the business activities

PlanDo

CheckAct

5.4.2 Competence of the person managing the audit programme

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Objective, scope, duration, number of audits

Number of activities to be audited

Complexity of activities to be audited

Conclusions of previous internal or external audits

Significant changes to operations

Product failures, health and safety incidents

PlanDo

CheckAct

5.4.3 Establishing the extent of the audit programme

Management system standards

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Establish the audit program - extent

• Influenced by the size, nature and complexity of the organisation (risk)

• Also:• importance of activities being audited• previous audit findings• significant changes to the organisation or its

operation

PlanDo

CheckAct

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Financial resources Audit methods Availability of auditors

Technical experts Travelling time, cost, accommodation

Information and communication technologies

PlanDo

CheckAct

5.4.4 Identifying audit programme resources

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Objectives: Do

PlanDo

CheckAct

5.5.1 General5.5.2 Defining the objectives, scope and criteria for an

individual audit5.5.3 Selecting the audit methods5.5.4 Selecting the audit team members5.5.5 Assigning responsibility for an individual audit to the

audit team leader5.5.6 Managing the audit programme results5.5.7 Managing and maintaining audit programme records

5.5 Implementing the audit programme

Competence and evaluation of auditors

(Clause 7)Performing an audit

(Clause 6)

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PlanDo

CheckAct

5.5.2 Defining the objectives, scope and criteria for an individual audit

Audit objectives• Define what is to

be accomplished by the individual audit

Audit scope• Physical location,

organisational units, activities and processes to be audited

Audit criteria• Reference

against which conformity is determined e.g. policies, standards, legal requirements

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PlanDo

CheckAct

5.5.3 Selecting the audit methods

Extent of involvement

between the auditor and the auditee

Location of the auditor

On-site Remote

Human interaction • Conducting interviews• Completing checklists and

questionnaires with auditee participation

• Conducting document review with auditee participation

• Sampling

Via interactive communication means:• Conducting interviews• Completing questionnaires

and checklists• Conducting document review

with auditee participation

No humaninteraction

• Conducting document review (e.g. records, data analysis)

• Observation of work performed

• Conducting on-site visit• Completing checklists• Sampling (e.g. products)

• Conducting document review (e.g. records, data analysis)

• Observing work performed via surveillance means, considering social and legal requirements

• Analysing data

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Ensure overall competence of the audit team:1. Identify the knowledge and

skills required to achieve the objectives of the audit

2. Select audit team members to that all of the necessary knowledge and skills are present in the audit team

PlanDo

CheckAct

5.5.4 Selecting the audit team members

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Information to provide to audit leader:• Audit report distribution requirements• Confidentiality requirements• Health and safety requirements• Security and authorisation

requirements• Follow-up actions from previous

reports

PlanDo

CheckAct

5.5.5 Assigning responsibility for an individual audit to the audit team leader

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PlanDo

CheckAct

5.5.6 Managing the audit programme results

Evaluate the achievement of the objectives for each audit

Review and approve audit reports

Review of root cause analysis and effectiveness of CAPAs

Distribution of audit reports to top management

Determination of necessary follow-up audits

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PlanDo

CheckAct

5.5.7 Managing and maintaining audit programme records

• Documented audit programme (including schedule) objectives and extent• Documents addressing audit programme risks and opportunities• Reviews of the audit programme effectiveness

Audit programme records

• Audit plans and reports• Objective audit evidence and findings• Nonconformity reports / Corrective and preventative action reports• Audit follow-up reports

Records relating to each individual audit

• Competence and performance evaluation of audit team members• Selection of audit teams and team members• Maintenance And improvement of competence

Records related to audit personnel

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Objectives: Check

PlanDo

CheckAct

5.6 Monitoring the audit programme

• Evaluate conformity with objectives• Evaluate audit team members’ performance• Evaluate audit teams’ ability to implement audit

plans• Evaluate feedback from management• Take note of changes that impact the audit

programme, for example:• Changes to suppliers, standards, legal requirements, or

auditee’s management system

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Objectives: Act

PlanDo

CheckAct

5.7 Reviewing and improving the audit programme

Review and improve audit programme• Monitoring results and trends• Conformity with procedures• Audit programme records• New/alternative auditing methods• Effectiveness of mitigation measures to address

audit programme risks• Confidentiality and information security issuesReport results to management

Conducting an Audit (ISO 19011 Clause 6)

PO1610_1_r01

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Conducting an audit

6.2 Initiating the audit

6.3 Preparing audit activities

6.4 Conducting the audit activities

6.5 Preparing and distributing the audit report

6.6 Completing the audit

6.7 Conducting audit follow up

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6.2 Initiating the audit

• Responsibility remains with the assigned team leader

6.2.1 General

• Can be formal or informal

6.2.2 Establish contact with auditee

• Sufficient and appropriate information for planning and conducting the audit

• Adequate cooperation from the auditee• Adequate time and resources for conducting the

audit.

6.2.3 Determine feasibility of audit

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Pre-Audit Meeting

• Best face-to-face• Discuss/agree on scope,

objective, timeo Identify constraints (people, process, time)

• Discuss information needed from manufacturer

• Discuss roles: o who should be the contact for the

manufacturer /departmento who is going to be the leader

• Prepare a draft audit plano Agree which parts will be covered by whom

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6.3 Preparing audit activities

6.3.1Perform document review in preparation for the audit

6.3.2 Prepare audit plan

6.3.3 Assign work to the audit team

6.3.4 Prepare work documents

Also Make appropriate travel arrangements

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Audit Plan

Risk based approach to planning:• Consider risk to auditee’s processes• Efficient scheduling to achieve the audit

objectives effectively• Audit plan details should reflect the

complexity of the audit as well as the risk of not achieving the audit objectives

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Audit Plan

Should include:• Audit objectives, scope, agenda

and criteria• Locations, dates, expected time

and duration of audit activities to be conducted

• Audit methods to be used, including sampling plan• Roles and responsibilities of audit team members• Allocation of appropriate resources to critical areas of

the audit

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Audit Plan

May also include:• Identification of auditee’s

representative for the audit• Working and reporting language

of the audit, if applicable• Audit report topics• Logistics and communications arrangements• Any specific measures taken to address the effect of

uncertainty on achieving audit objectives• Any follow-up actions from previous audit• Any follow-up activities to the planned audit

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Audit Plan

Consider preparing two copies:

• Include important points noted during preparation• Include significant deficiencies observed at previous

audit

One for the manufacturer

One for the audit team

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Select Audit Team

When selecting an audit team consider:

Allocate responsibilities including a team leader and technical specialist.

The audit scope

Expertise required

Available resources

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Pre-Audit Information

• Site Master File: size of company, products manufactured on site, organisation chart with responsibilities and authorities, processes, QA and QC structures, facility design, utilities etc.

• Facility plans, utility plans• Process flow charts (inclusive of equipment

and in process controls)• Number of batches manufactured• List of contracted manufacturers, testing laboratories• Performance indicators (number of

deviations, recalls, customer complaints, % products re-worked etc.)

Request relevant information from the manufacturer:

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Aide Memoires

• Aide memoires, if appropriately prepared, are excellent tools to be used during an audit.

• They should focus on those audit activities that were identified as significant and high risk during audit preparation and planning.

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Pre-Audit Information

Prepare an audit agenda• Agree on time to be

allocated to the audit and which parts will be covered by whom

Clarify all arrangements for the

first day

Always remember to:

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Activity 5: Audit Plan

Open your workbook

• You have been asked to conduct an audit of one of your suppliers.

• Use example Audit Plan & your standard to create your own plan for this audit.

• Present to the group.

Workbook:

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6.4 Conducting the audit activities

6.4.3 Conducting the opening meeting

6.4.6 Reviewing documented information while conducting the audit

6.4.4 Communicating during the audit

6.4.5 Audit information availability and Access

6.4.7 Collecting and verifying information

6.4.8 Generating audit findings

6.4.9 Determining audit conclusions

6.4.10 Conducting the closing meeting

6.4.2 Assigning roles and responsibilities of guide and observers

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Conducting the audit

Establish a good rapport by maintaining professional image throughout the audit and the follow up phases.

Be professional

Be polite and courteous

Be sensitiveto peoples reactions

Be properly prepared

Be punctual, clean and

tidy

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Strive to be precise at all times. Loosely phrased questions attract loose answers.

• Maintain concentration and focus• Be constructive• Think risk and stay balanced• Never criticise people• Avoid disputes• Allow people to “save face”

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Conducting an audit interview

• Interviewing is an important technique to collect information.

• The auditor(s) should:• conduct the interview during normal working hours• put the interviewee at ease, courtesies• explain the reason for the interview• initiate questions by asking the interviewee to describe their work.

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Recognise ploys that could be used to confuse or frustrate and take evasive actions:

à Handle these situations with courtesy, but firmly

Time wasting

Deliberate attempt to confuse

Deliberate attempt to intimidate the auditor

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Collect and verify information

Audit conclusions

Reviewing

Audit findings

Evaluating against audit criteria

Audit evidence

Collecting by means of appropriate sampling

Source of information

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Conduct the audit

• Sources will vary depending on the scope and complexity of the audit

• Sources of information include:• interviews with personnel• observation of activities and surrounding work environment• documents (policies, plans, procedures, forms, standards, instructions,

specifications, drawings, etc.)

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Conduct the audit

• Sources of information include:• records (inspection records, meeting minutes, batch records, audit reports, etc.)• customer feedback and complaints• corrective and preventative actions• computerised databases and websites.

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Audit techniques

• Trace forward – start with the raw material and follow the production flow (most common)

• Trace backwards – review history of a specific batch

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Audit techniques

• Random – start from points that appear significant e.g. complaint, CAPA, change control, training

• Functional – laboratory / production / research and development

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Note taking

It is important to take good notes on what, when and where. Notes must be accurate and legible.• These will be used for exit interview

(little preparation time) and preparation of your final report

Some useful hints on note taking:• Avoid long descriptive text• Use key words• Do not write anything down unless you understand it• Use symbols• Re-write at your earliest convenience

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Conducting an audit

• Summarise findings and try to get agreements

• List outstanding items• Communicate any changes to audit plan• Discuss disagreements• Confirm plan for the next day

Daily progress meetings

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Conducting an audit

• Encourage the management to invite all concerned

• Summarise your findings for each department:• Strengths• Weaknesses• Areas of concern

Closing meeting

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Final audit activities

6.5 Prepare and distribute

the audit report6.6 Complete

the audit6.7 Conduct

audit follow-up

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Audit Report

Sentences should be:• Grammatically sound and complete.

• e.g. Company quality system acceptable

This should read:• The company’s quality system was

acceptable.

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Audit Report

Sentences should be short…….but not too short:

The company had implemented an adequate system of quality management that met the requirements of the

PIC/S Code of GMP

The quality system was assessed as satisfactory

The quality system was assessed

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Audit Report

The report should be easy to read and understood by someone not at the audit.

If a sentence or paragraph doesn’t make sense to the audit reviewer, or has to be read three times to understand the issue, it needs a rewrite.

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Audit Report

• Audit report should be relatively brief.

• There may be exceptions where a report needs to be longer but this would be uncommon.

• A long audit report does not show that you are a better auditor!!

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Audit Report

• Write reports in past tense.• Do edit check for consistency before submitting report for review.

• e.g. The company has an appropriate complaints procedure and had documented the protocols required for recalls.

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Audit Report

The scope should document what you assessed at audit. • e.g. Manufacture of bulk soft gelatine capsules for complementary and OTC

medicines

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Audit Report

• Brief description of the company and its activities.Introduction:

• Ensure that you briefly document major changes since the last audit.

Changes:

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Audit Report

Audit findings:

All critical and major deficiencies to be cross referenced in the report.

Other deficiencies can be cross referenced in the report but this is not essential.

Deficiencies that reference an SOP should fully identify the SOP in question.

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Activity 6: Medicine inspection deficiencies

Open your workbook

• Determine if the inspection findings are Critical or Major deficiencies

• Work in teams

• Present to the group

Workbook:

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TGA Guidance on inspections

• Describes: the inspection process• Appendix 1: Performance measures

and targets• Appendix 2: Examples of medicine

inspection deficiencies• Critical• Major

• Appendix 3: Examples of devices inspection nonconformities

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Audit Report

There should be consistency between the body of the report and the recorded deficiencies.• e.g. The documentation system should not be recorded as being of a good

standard if there are multiple deficiencies in relation to it.

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Audit Report

• Reporting of deficiencies in Audit Report.

• Only deficiencies for which a relevant reference (clause) could be found in the relevant Code or Standard, or Company Policy should be listed.

• All deficiencies must be supported by objective evidence recorded at the time of audit.

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Audit Report

All deficiencies should be discussed at the exit

meeting.

Those of special significance should be stressed, particularly

those that could result in a significant decision.

Deficiencies should be concisely and clearly

worded.

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Audit Report

Where appropriate, group only examples under a single core deficiency.

Detail the core deficiency……………., for example:• Detail the first example of the core deficiency….• Detail the second example of the core deficiency….• Etc

• (Enter relevant Code/Reference clause(s)…….)

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Audit Report

Examples listed must be clearly relevant to the core deficiency. If there is any

doubt, the deficiency should be listed separately.

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Audit Report

• Think of the people who may read it.• Be objective. Be diligent. Pay attention to detail.

• Keep deficiencies simple and clear. Use wording from a relevant clause in the Code or Standard.

• Always reference the correct clause(s).• Be factual. Every deficiency must be supported by

evidence gathered during the audit.

When preparing an Audit Report:

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Audit Close Out

• Use formal “Audit Close Out” record for communications.

• “Critical” and “Major” deficiencies should be closed on provided evidence.

• “Other” deficiencies could be closed on corrective action plan and target day for completion.

• All audits should be reviewed upon completion.

Module 8: Audit Trends and Findings

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RCA, CAPA (human error)1RCA for significant Deviations2Records not completed in real-time3Doc control and integrity of records4Doc design, distribution and reproduction5Product Quality Reviews6Documents – unambiguous, approved7Training8Storage areas - conditions9Equipment calibration10

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FDA Warning Letter Review

• Official message from the US FDA to a manufacturer that has violated some rule in a federally regulated activity.

• Warning Letters should only be issued for violations of regulatory significance, i.e., those that may actually lead to an enforcement action if the documented violations are not promptly and adequately corrected.

• A Warning Letter is one of the Agency’s principal means of achieving prompt voluntary compliance with the Act.

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Activity 7: Audit Report Review

Review your chosen FDA Warning Letter and list the main deficiencies cited in the audit report.

Contribute to group discussion

Workbook:

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Summary…..

• Focus on improving RCA techniques and CAPA• Verify your supply chain for critical materials• Perform a Data Integrity Gap Analysis and include DI

in your self-inspection program• Use the Management Reviews and PQRs to identify

improvement opportunities• Strengthen your training strategy – not just tick the

box but move to competency mindset• Ensure you have a strong strategy regarding cross-

contamination prevention and include this as part of the QRM process

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Course Agenda

01 Introduction

02 Types of inspections

03 The art of inspecting

04 Communication styles

05 Difficult behaviour

06 Risk-Based Inspections

07 Managing the audit program

08 Audit trends and findings

© PharmOut 2020

Course Assessment – Online GMP

At the end of the training you will complete an online assessment through www.onlinegmptraining.com:

• You have 60 days access to complete the assessment and evaluation and download materials.

• The assessment is ‘open book’

• The assessment will take Approximately 10 minutes and you will get your certificate

© PharmOut 2020


Various documents

Presentation

EvaluationAssessment

Course Title

Course Information

1. Mark Complete

2. Complete Evaluation

3. Complete Test

4. Download Certificate

© PharmOut 2020

Thank you for your time.Questions?

Maria Mylonas

[email protected]

Learning & Development Director

www.pharmout.net

PowerPoint Template - Online GMP Training

Documents

Transcript of PowerPoint Template - Online GMP Training