FDA Inspection (Recorded)

Non-compliance is an expense that no healthcare company can afford. Companies must establish proven and sustainable GXP Compliance Strategies and risk mitigation strategies when responding to a crisis so you avoid costly product approval delays, recalls and adverse impacts on shareholder value, including FDA enforcement actions. Companies must adopt a risk-based approach to managing quality and regulatory compliance not only for GCP, GLP and GMP but across the entire platform. Whatever solution you are using it needs to provide a common framework and an integrated approach to meet FDA GxP regulations through effective risk management, document control, compliance training, ongoing auditing, surveillance and monitoring activities and other critical areas that will be addressed during the seminar.

This is a practical, hands-on two-day seminar designed to provide pharmaceutical, biopharmaceutical, biologics and medical device professionals with the information and tools they require to prepare for and manage an FDA inspection efficiently, effectively, and successfully. Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer. This presentation will review and emphasize the do's and don'ts and cardinal rules as to interviewing, how to respond, reviewing documentation, etiquette, use of certain words, body language, responding to questions/requests, etc., and certainly replying to 483's and Warning Letters.

The course will go through what typically goes on during an FDA Inspection and will then cover how to prepare for, host and follow up to a regulatory inspection. It will emphasize and focus on the critical and vital elements that you should do or not do during the inspection. Typically, FDA inspections can be highly structured and there are procedures that are to be followed as you prepare for state of readiness. It is important for anyone who might be involved in the inspection to be aware of these procedures, including all employees and personnel to ensure there are no surprises.

The course will also provide information for inspections conducted by international agencies as well as non-FDA agencies, including self-inspections for manufacturing and the famous FDA Mock Inspection or Mock Audit. It will explain how to prepare for an inspection, how to handle a scheduled or non-scheduled inspection, what to expect during an inspection, and what follow-up to expect after an inspection.

Why Should You Attend?

• Define and execute proven GxP Compliance Strategies
• Proven Operational Readiness and State of Readiness tactics
• Determine optimal pathway during inspections and post-inspection correspondence and meetings
• Identify the visible signs of GXP compliance that are present as a daily reminder of the importance of GXP compliance with “risk-based” awareness demonstrated by companies
• Improve credibility and trust with the FDA and other regulators
• Important training areas in GxP compliance and topical issues
• Gain a better understanding of how to interact and communicate effectively with FDA
• Identify the ground rules and do’s and don’ts with FDA inspections
• Learn what the FDA can request and not request during an inspection
• Understanding the interview process and why pre-inspection planning is critical for your company
• Navigate the inspection process from preparation, and execution to close-out and debrief/exist interview
• FDA authority and process including 483s, Warning Letters, recalls, and other potential actions
• The FDA inspection process and approach
• The use of a mock audit and outside certifying audit
• Required documentation, format, and archive
• How to respond to inspection and audit results
• In a group setting, review and discuss pain points, challenges and workable regulatory and compliance solutions for any FDA inspection
• Prepare for lively discussions and a Mock Inspection as part of a classroom exercise
• Communicate effectively with FDA and reference FDA guidance and other critical resources

12.0 RAC CREDITS

RAPS - This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.