The document outlines a webinar focused on FDA inspection readiness, covering topics such as the inspection process, types of inspections, and strategies for preparation and compliance. Key points include the importance of selecting and training subject matter experts (SMEs) and best practices for maintaining compliance with FDA regulations. The document emphasizes the need for effective communication, documentation, and operational improvements to ensure a successful audit.

1. Live Webinar
on
FDA Inspection
Readiness – Preparing
for an Inspection
Name of the Presenter.
Charles H Paul, President
C. H. Paul Consulting, Inc.

2. Topics
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◼ The mechanics of the readiness process, auditing – who gets audited,
frequency of audits, and the inspection process explained
◼ Types of inspections and their implications
◼ The heart of compliance – doing the right things right
◼ Selecting your subject matter experts
◼ Training your SME’s – what do they need to know and how do you train
◼ Inspection preparedness – what to expect and how to prepare
◼ The readiness inspection from the auditor’s perspective
◼ Responding/interacting with the inspection team – inspection behavior –
how to act – what to say and what not to say

3. Who does the FDA Inspect?
◼ Federal Food, Drug, and Cosmetics (FD&C) Act, domestic drug
establishments, and Class II and Class III device manufacturers inspected
every two years
◼ Foreign manufacturers
◼ Inspections conducted based on risk
◼ Higher-risk products more likely to be audited
◼ Facilities having historically significant violations
◼ Inspection focus
 Quality and Product Safety
 Facility
 Process
 Data
3

4. Purpose of Inspections
4
• Compliance with FDA regulations
• Product development
• Quality System (QS) and manufacturing practices
• Controls are in-place and they are effective
• Recalls, enforcement actions, complaints, significant
adverse event reports, surveillance
• Ensure consumer protection

5. Types of Inspections
5
◼ Pre-Approval Inspections (PAI Post-Approval Inspections
◼ Surveillance Inspections
◼ For-Cause or Triggered Inspections
◼ Compliance Follow-Up Inspections
◼ Foreign Inspections
◼ Focused Inspections
◼ Risk-Based Inspections
◼ Follow-Up or Recurrent Inspections
◼ Adverse Event Inspections
◼ Import Inspections
◼ Bioequivalence and Bioavailability Inspections

6. Types of Inspections
◼ Pre-Approval Inspections
◼ Post Approval Audit Inspections
◼ Drug Manufacturing Inspections
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7. Pre-Approval Inspections
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◼ FDA approves New Drug Applications, Abbreviated New
Drug Applications, Biologic Licensing Applications
◼ Assure that controls for manufacture, processing,
packing, and testing are adequate
◼ Pre-approval inspection performed to ensure that
manufacturer can manufacture the drug.

8. Post Approval Audit Inspections
8
◼ Designed to audit for changes in the production and
control practices that occur after approval
◼ Post Approval Audit Inspections confirm that
commitments have been completed or are underway

9. Drug Manufacturing Inspections
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To determine whether inspected firms
are operating in compliance with
applicable cGMP requirements

10. Best Practices – “Do the right Things Right”
10
◼ 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

11. Inspection Process Overview
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❑ Alert system activated
❑ Company Inspection Team members assemble
❑ FDA provides the company with Form 482
❑ FDA will explain why they are at your site
❑ FDA provided with a facility tour
❑ FDA inspection team, will request the documents they
need
❑ FDA will conduct the Exit Inspection Meeting.
❑ FDA findings are reviewed

12. 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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13. Post Inspection
13
◼ If the inspection has an Official Action
Indicated classification, FDA send a
warning letter
◼ Company will need to reply
◼ FDA conducts a follow-up inspection
◼ FDA may issue a close-out letter

14. Why are SME’s Indispensable to the Organization?
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◼ Expertise in Specific Areas
◼ Demonstrating Compliance
◼ Preparing Documentation
◼ Training and Coaching Staff
◼ Addressing Non-Compliance Issues
◼ Facilitating Communication
◼ Ensuring Ongoing Compliance

15. Who are SMEs?
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◼ Quality Assurance (QA) and Quality Control (QC) Experts
◼ Regulatory Affairs Specialists
◼ Manufacturing and Process Engineers
◼ Microbiologists and Chemists
◼ Clinical Research Professionals
◼ Pharmacovigilance Experts
◼ Labeling and Packaging Specialists
◼ Validation Experts
◼ Food Safety and HACCP Experts
◼ Clinical Laboratory Directors
◼ Environmental Health and Safety Specialists
◼ Documentation and Records Management Experts

16. Why is Proper SME Selection Important to the FDA
Inspection?
44
◼ Accuracy and Credibility
◼ Regulatory Understanding
◼ Effective Communication
◼ Smooth Inspection Process
◼ Confidence and Professionalism
◼ Problem-Solving Abilities
◼ Representation of Expertise
◼ Mitigating Risks
◼ Resource Efficiency
◼ Long-Term Impact
◼ Employee Morale
◼ Organizational Preparedness

17. Selecting SMEs
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◼ Identify Relevant Areas
◼ Define SME Criteria
◼ Cross-Functional Representation
◼ Regulatory Knowledge
◼ Communication Skills
◼ Experience with Inspections
◼ Problem-Solving Abilities
◼ Preparation and Training
◼ Calm Under Pressure
◼ Collaborative Attitude
◼ Post-Inspection Feedback

18. Preparing SME’s
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◼ Provide In-Depth Regulatory Training
◼ Review Inspection Process and Expectations
◼ Mock Inspection Workshops
◼ Communication Skills Training
◼ Prepare Documentation
◼ Familiarize with Facility Layout
◼ Prepare for Questions
◼ Confidence Building
◼ Team Collaboration
◼ Role-Playing Scenarios
◼ Post-Preparation Feedback

19. 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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20. What a Successful FDA Audit Looks Like
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◼ Compliance with Regulations
◼ Public Health and Safety
◼ Market Confidence
◼ Continued Market Access
◼ Operational Improvements
◼ Reduced Legal and Financial Risk
◼ Enhanced Consumer Trust
◼ Facilitates Innovations
◼ Employee Morale and Engagement
◼ Educational Opportunity

21. Tips for Doing it Right
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◼ Understand the Scope and Standards
◼ Maintain Compliance at All Times
◼ Conduct Regular Internal Audits
◼ Prepare Your Team
◼ Organize Documentation
◼ Review Past Inspections
◼ Mock Inspections
◼ Improve Communication Skills
◼ Ensure Facility Readiness
◼ Stay Informed About Industry Changes
◼ Legal and Expert Consultation
◼ Handle Issues Professionally

22. Review
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◼ Always be prepared by doing the right things right
◼ Always maintain a compliant GMP environment
◼ Have effective and accessible compliance documentation
◼ Have a plan for how you will manage your inspection
◼ Be professional during an inspection
◼ Demonstrate proper body language
◼ Be timely in providing the documents and samples requested
◼ Control the flow of communication
◼ Properly answer questions
◼ Respond to findings thoroughly and in a timely manner

23. Questions
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