How to Most Effectively Prepare for and Manage FDA Inspection: Best Practices

Instructor: David Lim 
Product ID: 703245
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Jul-2015

Training CD / USB Drive

One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

This training program will discuss why it is important for you to be better aware of and to become better acquainted with FDA inspection best practices. In particular, the webinar will detail a list of Dos and Don’ts before, during and after the inspection.

Why Should You Attend:

This webinar will help attendees prepare for and manage an FDA inspection. The training program is integrated with emotional intelligence (EQ)-based practical and actionable guidance so that a firm’s preparation and management for an FDA inspection can be done in a more effective, meaningful and easily manageable manner at all levels of an organization.

At the end of the webinar, attendees will become familiar with the FDA inspection process to ensure proactively preparing for and better managing FDA inspection matters in a much less burdensome manner.

Learning Objectives:

  • To be familiar with FDA inspection preparation and management
  • To learn how to host an FDA inspection

Areas Covered in the Webinar:

  • FDA Authority for Inspection
  • Definitions
  • FDA Manuals for FDA Inspection
  • FDA Inspection Scope, Types and Categories
  • FDA Inspection Process
  • Hosting an FDA Inspection
  • Answering Questions
  • Responding to 483: Common Mistakes
  • Dos and Don’ts Before, During and After FDA Inspection
  • Misconception and Frequent Mistakes
  • Recent Enforcement Cases
  • Best Practices: Dos and Don’ts
  • Conclusion

Who Will Benefit:

  • Senior Management
  • Compliance Officers
  • Attorneys
  • Regulatory Affairs
  • Clinical Affairs
  • Quality Assurance
  • R&D
  • Consultants
  • Contractors/Subcontractors
  • Anyone Interested in the FDA (BIMO) Inspection Process

Instructor Profile:

Dr. David Lim, Ph.D., RAC, ASQ-CQA, is president and principal of Regulatory Doctor. He frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, he developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past eight years. Dr. Lim provides his feedback to regulatory agencies (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009. He contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. He serves as a member of the Advisory Board for Inspection Insider published by FDA News.

Follow us :
Seminars by Ex-FDA Officials
CLIA Waiver and Dual 510(k) CLIA Waiver Submissions to FDA

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email call +1-888-717-2436 (Toll Free).

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