2018: FDA's New Inspection Policy and Strategic Regulatory Updates

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

Pack of 3 Bestselling Webinars for a Steal Away Price of $449!

In FDA-regulated industries, it is imperative that firms be well aware of and understand the laws and regulations governing FDA-regulated medical products (e.g., food, drugs, biologics, cosmetics, and medical devices including in vitro diagnostics). In particular, it is important to recognize policy changes and risk-based, strategic regulatory and compliance approaches (best practices) under the new administration.

In these sessions, expert speaker Dr. David Lim, Ph.D., RAC, ASQ-CQ, will discuss FDA’s policy changes, risk-based regulatory and compliance approaches under the new administration for 2018 and beyond. David will help you better prepare for risk-based FDA inspection and management, in a proactive and effective manner. David will share his actionable tips and advice in view of recent FDA policy changes and enforcement actions. He will help you improve your awareness and knowledge of FDA enforcement and inspection policy and risk-based approaches under the new administration.

1)  Preparing for 2018: FDA Inspection Policy and Best GMP Practices

Duration: 60 minutes

Session Agenda

  • 2018: FDA’s major policy goals
  • Investigations Operations Manual (IOM)
  • FDA investigator’s arrival – Dos
  • FDA inspection logistics – Dos
  • Contract Research Organization (CRO)
  • Sponsor/CRO/Monitor (SCM) inspections (General)
  • Responding to 483s (highly recommended)
  • FDA inspection management (good practices)
  • FDA pre-approval GMP inspection checklist for drugs
  • Top twenty (20) deficiencies cited in 483s for drugs
  • Top twenty (20) deficiencies for  devices
  • Administrative/civil/criminal actions
  • Practical and actionable lessons

2)  2018 and Beyond: FDA’s New Policy and Risk-Based Strategic Regulatory Updates Under New Administration

Duration: 60 minutes

Session Agenda

  • FDA Inspection authority, regulation, and manuals
  • Federal food, drug, and cosmetic act (the Act)
  • FDA regulations and additional laws enforced by the FDA Code of Federal Regulations (CFR) - Title 21
  • Guides to inspections (e.g., computer issues and BIMO of IVDs)
  • Compliance Program Guidance Manual (CPGM)
  • Statement from FDA Commissioner Scott Gottlieb, M.D.
  • Congresswomen meeting with the FDA commissioner: Contraceptive devices
  • What does FDA do before FDA (BIMO) inspection?
  • Inspection types and categories
  • Does FDA preannounce an FDA inspection (e.g., BIMO)?
  • Form FDA 482 and 483
  • Communication during FDA inspection – Don’ts
  • Training employees: Awareness

3)  What to Expect from Changes in FDA Policy and Inspection Operation in 2018

Duration: 60 minutes

Session Agenda

  • The Opioid (OxyContin) manufacturer stops promoting opioids
  • Updated FDA inspection manual
  • Depth of inspection
  • FDA investigator’s authority and responsibility
  • How to answer during FDA inspections – Dos
  • Sponsor’s specific responsibilities
  • Sponsor’s transfer of obligations

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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 (www.RegulatoryDoctor.us). 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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