FDA Best Audit Practices – Get Ready For The Inspection That Is Coming

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

• 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 SMEs 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 auditors
  perspective
• Responding/interacting with the inspection team
  inspection behavior
• how to act what to say and what not to say

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• Who does the FDA Inspect?
• Federal Food, Drug, and Cosmetics (FDC) 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

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Purpose of Inspections

• 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

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Types of Inspections

• 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

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• Types of Inspections
• Pre-Approval Inspections
• Post Approval Audit Inspections
• Drug Manufacturing Inspections

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Pre-Approval Inspections

• 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.

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Post Approval Audit Inspections

• 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

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Drug Manufacturing Inspections
To determine whether inspected firms are
operating in compliance with applicable cGMP
requirements
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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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Inspection Process Overview

• 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

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• 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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Post Inspection

• 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

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Why are SMEs Indispensable to the Organization?

• Expertise in Specific Areas
• Demonstrating Compliance
• Preparing Documentation
• Training and Coaching Staff
• Addressing Non-Compliance Issues
• Facilitating Communication
• Ensuring Ongoing Compliance

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Who are SMEs?

• 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

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Why is Proper SME Selection Important to the FDA
Inspection?

• 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

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Selecting SMEs

• 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

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Preparing SMEs

• 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

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• 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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What a Successful FDA Audit Looks Like

• 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

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Tips for Doing it Right

• 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

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Review

• 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

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Questions
Register Now
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