Preparing for an FDA Inspection: What to Do and What Not to Do

Event Information
Product Format
Prerecorded Event
Dr. David Lim, Ph.D., RAC, ASQ-CQA
60 minutes
Product Description

What Can You Learn from FDA Enforcement and Inspection Practices

In FDA-regulated industries, firms must comply with a range of laws and regulations that apply to medical and other products such as food, drugs, biologics, cosmetics and medical devices, including those for in vitro diagnostics. The FDA’s Office of Regulatory Affairs (ORA) handles inspections to enforce these regulations, and if ORA investigators find violations, they list their observations on the FDA Form 483.

Join this session with expert speaker Dr. David Lim, Ph.D., RAC, ASQ-CQA, who will discuss FDA inspection practices and help you better prepare for and manage an FDA inspection. David will show you how to take a proactive and effective approach, including do’s and don’ts for before, during and after the inspection. David will also share his analysis of Form 483s and FDA warning letters issued for the past several years.

The session will provide you with key lessons learned from actual FDA enforcement and inspection practices. It will also provide you with an opportunity to get familiar with FDA enforcement actions and the agency’s inspection process. David will also share his PASS-IT recommendation/suggestions, which will help you put these crucial do’s and don’ts into practice.

Session Highlights

This session will cover:

  • Applicable laws and regulations
  • FDA manuals
  • Inspection types, categories and classification
  • FDA Forms 482 and 483
  • Inspection reports
  • Most common deficiencies
  • What/how to prepare for and manage an FDA inspection
  • Why communication is important: Dos and don’ts for communicating with the agèncy
  • Inspection preparation and management
  • Communication with EQ skills
  • Employee training
  • Actual case studies
  • Speaker’s PASS-IT suggestions and recommendations

Session Agenda

  • FDA inspection laws, regulations and guidance manuals
  • Legal authority for cGMP
  • Field management directives manual
  • Investigations operations manual (IOM)
  • Compliance program guidance manual (CPGM)
  • Misconception, frequent mistakes, and how to best deal with them
  • How FDA prepares for its BIMO inspection
  • Inspection types and categories
  • FDA inspection pre-announcements
  • FDA investigator’s authority and responsibility
  • Forms FDA 482 and 483
  • Dos and don'ts of communication during FDA inspection
  • Roles and responsibilities of sponsors, monitors and contract research organization (CRO)
  • Sponsor/CRO/Monitor (SCM) inspections
  • FDA pre-approval GMP inspection checklist for drugs
  • 2017 inspection enforcement trend
  • FDA enforcement for contract manufacturing
  • FDA inspection management

Who Should Attend

  • CEOs
  • VPs
  • Compliance officers
  • Attorneys
  • Regulatory affairs
  • Clinical affairs
  • Quality assurance
  • R&D
  • Consultants
  • Contractors and subcontractors
  • Anyone Interested in the FDA regulatory pathways for new drugs and generics

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About Our Speaker

Dr. David Lim - FDA Medical Device  Regulation Expert

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor ( As a leading industry speaker, Dr. Lim frequently presents various topics in areas of FDA regulatory, clinical, quality and regulatory compliance matters in various forums and meetings.

Dr. Lim has helped both pharma and medical device industry for regulatory, clinical and compliance...   More Info
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