Course Format
- Online, Live Virtual
- Real Inspection Examples & Case Studies
- Mock FDA Inspection Exercises
- Practical Preparation Strategies
- Interactive Q&A & Compliance Best Practices
- 10 hours of Continuing Education Certificate of Completion
During inspections, investigators evaluate your quality systems, documentation, data integrity, and overall compliance with cGMP requirements.
This training provides a practical, real-world approach to preparing for and managing FDA inspections - helping you avoid common mistakes and respond effectively during audits.
By attending this training, you will be able to:
- Understand how FDA inspections are conducted and what inspectors look for
- Prepare your facility, documentation, and team for inspections
- Handle investigator questions and interactions confidently
- Avoid common mistakes that lead to 483 observations
- Respond effectively to inspection findings and implement CAPA
Why this training is important:
- FDA inspections assess compliance with cGMP and regulatory standards
- Inspection findings can result in 483 observations, warning letters, or delays
- Many companies struggle with inspection readiness and response strategies
- What you will be prepared for:
- Pre-approval inspections
- Routine GMP inspections
- For-cause inspections
- Handling FDA investigator questions
Course Content
Day 1
Day 2
Exercise on Day 2
Agenda
Day 1: FDA Inspection Readiness & Compliance Fundamentals ( 5hrs)Session 1: Introduction & Regulatory Foundation
- Introductions and participant background
- Overview of FDA’s inspectional authority and history
- Why FDA inspections are conducted and statutory basis
- Scope of FDA jurisdiction: what is covered vs. off-limits
- FDA inspection program overview
- Systems-based inspection approach
- Key FDA reference documents (IOM and related guidance)
- Enforcement categories and prohibited acts
- Key factors for a successful FDA inspection
- Building Quality System Readiness
- Organizational readiness and inspection planning (SOPs)
- Defining roles, responsibilities, and inspection response teams
- Ensuring required documentation is complete and inspection-ready
- Information management during inspections
- How to prepare your facility for an FDA inspection
- Training employees for inspection readiness
- Interacting with FDA investigators: Do’s and Don’ts
- Handling FDA interviews with employees and personnel
- Managing real-time inspection scenarios
- What to do when the inspection ends
- Exit interview best practices
- Responding to Form 483 observations and warning letters
- Documentation, remediation, and achieving closure
- Legal implications of non-compliance
Session 1: Compliance Recovery & Risk Management
- Strategies to maintain or return to regulatory compliance
- Minimizing operational downtime after inspection findings
- Establishing a proactive risk management plan
- Building an effective crisis management strategy
- Understanding the compliance remediation lifecycle
- Identifying issues, root cause analysis, and corrective actions
- Preventive strategies to avoid recurrence
- Strengthening your overall GxP compliance framework
- Overview of PDUFA meetings and Sponsor-FDA interactions
- How to request and prepare for FDA meetings
- Pre-submission meeting guidance and expected timelines
- Best practices for effective communication with FDA
- Key tactics for successful regulatory engagement
- Understanding Untitled Letters vs. Warning Letters
- Prioritizing follow-up on enforcement actions
- Developing a structured Warning Letter close-out process
- Ensuring timely and effective regulatory responses
- Review of recent FDA enforcement trends and observations
- Key compliance risks and emerging regulatory focus areas
- Lessons learned from past inspection outcomes
- Importance of mock inspections and audits
- Role-playing FDA inspection scenarios
- Preparing teams for real inspection environments
- Conducting internal audits to assess readiness
Course Provider
Kelly Thomas,
