3-Hour FDA Audit Preparation Virtual Seminar

This seminar is broken into two phases. Phase one corresponding to Day 1 will build basic knowledge of the inspection – the who, what, and when. Phase Two will delve into the how of the inspection from the perspectives of the FDA and those being inspected.

One of the key components discussing and emphasizing the importance of truthfulness to the process – truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors.

Another key component of this seminar is the discussion of the tricks and techniques that inspectors use to elicit information. How you react and respond when they occur could impact your results.

Other key communication skills will be presented in the context of the inspection and interpersonal exchanges between inspectors and company associates being questioned.

We will complete the seminar by discussing how to handle, in the moment, adverse findings as they are identified by the inspector so as to not compound the issues and severity of the findings.

Register,
https://conferencepanel.com/conference/3-hour-fda-audit-preparation-seminar

1. FDA Audit, Preparation,
Inspection, Conduct
Do’s and Don’ts
By Speaker
Charles H. Paul, President
C. H. Paul Consulting, Inc.
© 2024 C. H. Paul Consulting Inc. All rights reserved

2. 2
Topics
◼Inspection basics
◼Types of inspections
◼Consequences of non-
compliance
◼Why does the FDA inspect?
◼Who does the FDA inspect?
◼Good Manufacturing
Practices
◼Who are the inspectors and
how do they work.
◼Investigation reference
documents
◼How to prepare for an FDA
inspection
◼Quality System Inspection
Readiness
◼Records and documents
◼CAPA and the FDA inspection
◼Inspection prep for CAPA
◼Data integrity
◼The inspection process
◼Personal behaviors during
the inspection

3. 3
FDA Inspections Introduction
◼The Food and Drug Administration (FDA) plays a pivotal role in
safeguarding public health by regulating various sectors within
the life sciences industries.
◼Central to its regulatory framework is the practice of conducting
inspections.
◼Inspections serve as a crucial mechanism for ensuring
compliance with regulatory standards and Good Manufacturing
Practices (GMP).
◼FDA inspections are unannounced and encompass a
comprehensive review of all aspects of production.
◼During inspections, FDA investigators meticulously evaluate
facilities' adherence to regulations.
◼By scrutinizing critical components, the FDA aims to identify any
deviations or deficiencies.
3

4. 4
Types of Inspections
◼Pre-Approval Inspections (PAIs)
◼Post Approval Inspections
◼Routine Surveillance Inspections
◼For-Cause or Compliance Follow-Up
Inspections
◼Post-Market Inspections
◼Import Inspections
4

5. 5
Difference between Post Approval, Post Market, and
Surveillance Inspections
◼Post-Approval FDA Inspection: Occurs after a product has
received regulatory approval or clearance
◼Post-Market Inspection: Conducted after a product has
been approved or cleared for marketing Routine
◼Surveillance Inspection: Conducted periodically or as
needed to assess compliance with regulatory
requirements.

6. 6
Inspection Overview
◼Initiated without prior notice,
◼FDA inspections are conducted by trained investigators
◼Manufacturing facilities, laboratories, and processes are
examined.
◼These inspections may be routine or conducted in response
to complaints, adverse events, or emerging safety
concerns.
◼Investigators employ a systematic approach to evaluate
facilities' adherence to Good Manufacturing Practices
(GMP) and other regulations.
◼Reviewing critical documentation such as standard
operating procedures.
◼Investigators assess the physical infrastructure of facilities.
6

7. 7
What Is The Difference Between Inspections?
◼Pharmaceutical inspections
◼Biotechnology inspections
◼Medical device inspections
◼Combination product inspections
7

8. 8
What is a Warning Letter?
◼The issuance of a warning letter represents a formal notice
from the FDA to the recipient that corrective actions are
required.
◼Warning letters are considered public documents and are
typically posted on the FDA's website for public access.
◼The issuance of a warning letter may have significant
implications for the recipient, including reputational
damage, increased regulatory scrutiny, and potential legal
liabilities.
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9. 9
Why Is Sound Inspection Preparation Important?
◼Regulatory Compliance standards during inspections.
◼Risk Mitigation
◼Reputation Management
◼Product Quality and Safety
◼Business Continuity
◼Continuous Improvement
9

10. 10
Critical Inspection Mistakes
◼Inadequate Documentation
◼Poor Record-Keeping Practices
◼Non-Compliance with GMPs/QSRs
◼Lack of Adequate Training
◼Insufficient Risk Management
◼Ineffective CAPA Processes
◼Poor Communication with FDA Inspectors
◼Failure to Implement Lessons Learned
10

11. 11
Best Practices – “Do the right Things Right”
◼Preparation
•Have adequately trained staff with relevant expertise and accountability.
•Obtain upper management support
•Utilize and value independent regulatory compliance and quality assurance
teams
•Ensure the commitments made from previous inspections have been
implemented
•Understand your potential quality data sources so information can be quickly
and easily sourced as required
•Implement and assess an effective quality system
•Ensure there is a designated company Inspection Team
•Ensure all proper documentation and records are up-to-date
•Maintain effective Management Review and CAPA systems.
•Identify true root causes of issues using appropriate problem-solving tools.
•Understand when a product, or quality issue is significant.
•Have defined metric systems to monitor your quality system in order to identify
trends, gaps, and opportunities
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12. 12
◼What is the implied documentation expectation?
That documents are complete – provide all necessary information
Clear – easily understood
◼Visual
◼Flawlessly written
Accurate - timely
Provide sufficient information for users to exactly perform the task
in the case of WI’s or exhibit the behavior in the case of other
general/policy SOPs
Are consistently followed – management element
Controlled and secure
Easily revised as requirements change
Training element
What is the Regulatory Expectation?

13. 13
What is CAPA?
◼Corrective and Preventive Actions. It is a systematic approach
used by organizations to identify, investigate, and address non-
conformities, quality issues, and potential risks.
◼The purpose of CAPA is:
Corrective actions focus on addressing an existing issue or non-
conformance, aiming to eliminate the root cause, mitigate
immediate risks, and restore compliance.
Preventive actions are proactive measures implemented to prevent
the recurrence of similar issues or potential problems in the
future.

14. 14
Preparation Steps
◼Understand Regulatory Requirements
◼Review and Update CAPA Procedures
◼Conduct Internal Audits
◼Train Personnel
◼Perform Mock Inspections
◼Document and Organize CAPA Records
◼Conduct CAPA System Review
◼Stay Updated on Regulatory Changes
◼Maintain a Culture of Compliance

15. 15
What is Data Integrity?
◼Data integrity refers to the accuracy, reliability, and
consistency of data
◼It is a fundamental aspect of regulatory compliance
◼Data integrity encompasses various principles, practices,
and controls

16. 16
Elements of Data Integrity
◼Accuracy
◼Completeness
◼Consistency
◼Validity
◼Timeliness
◼Security
◼Traceability

17. 17
Common Data Integrity Violations
◼Failure to maintain complete data derived from all
laboratory tests conducted to ensure compliance with
established API specifications and standards
◼Failure to prevent unauthorized access or changes to data,
and failure to provide adequate controls to prevent
omission of data
◼Failure to record activities at the time they are performed
and destruction of original records.
◼Failure to train employees on their particular operations
and related GMP practices.

18. 18
Common Data Integrity Errors
◼Incomplete Data
◼Data Falsification
◼Data Entry Errors
◼Data Overwriting
◼Data Duplication
◼Data Loss or Corruption
◼Lack of Data Traceability
◼Non-Compliant Electronic Records
◼Poor Data Management Practices
◼Insufficient Training and Oversight

19. 19
Documents that Cannot be Reviewed
•Audit reports
•Financial records and documents
•Research data/protocols
•Personnel records
•Management meeting minutes
19

20. 20
Exit Process
◼Inspector will present a written FDA form (FDA 483) if
necessary
◼Company should take extensive notes and make sure
everyone understands the issues
◼Any response to a 483 observation by the company
should be brief
◼If issue remains unresolved, request that the inspector
annotate the FDA 483
◼Note any corrective actions
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21. 21
Post Inspection
•Date of inspection
•Inspection team members
•Reasons for response
•Response to each cited deficiency
•Description of preventive and corrective action
•Items still in dispute
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22. 22
The Psychology Of Behavior And Communications
◼Trust and Rapport Building
◼Perception and Interpretation
◼Active Listening
◼Emotional Intelligence
◼Assertiveness and Advocacy
◼Conflict Resolution
◼Cultural Sensitivity and Diversity
◼Posture and Nonverbal Communication

23. 23
Behaviors That Must Be Exhibited
◼Professionalism
◼Cooperation
◼Transparency
◼Documentation
◼Attention to Detail
◼Compliance Mindset
◼Timeliness
◼Positive Attitude

24. 24
Doing The Right Thing
◼Always be professional
◼Be dressed properly – neat and clean
◼Follow all company cleanliness, movement, and dressing
requirements
◼Be courteous and polite at all times
◼Correct all errors and miscommunications when discovered
as soon as possible
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25. 25
Doing The Right Things
•When providing documents do so in a timely
manner
•Have documents available
•Limit the inspector’s access
•Always review the requested record before
providing
•Check that the record is the one asked for
•Send only the record
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26. 26
Dealing With Difficult Inspections and Inspectors
◼Remain Calm and Composed
◼Listen Attentively
◼Clarify Misunderstandings
◼Redirect to Procedure
◼Seek Resolution
◼Invoke Chain of Command
◼Document Interactions
◼Follow Up Appropriately

27. 27
Questions
© 2024 C. H. Paul Consulting Inc. All rights reserved