FDA Inspection Policy and Best GMP Practices

  • Speaker:Dr. David Lim
  • Date: 9th August 2017 10:00 AM PST | 01:00 PM EST
  • Duration:60Min
  • Product Code:GRC-90173

$229

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Description:

This seminar will discuss what FDA-regulated industry should know about FDA’s current inspection policy to adequately implement the Good Manufacturing Practices (GMPs). The common GMP deficiencies cited in 483s issued to medical device and pharmaceutical manufacturers will be discussed. The most common deficiencies are based on the speaker’s analysis of 483s issued for the past eight (8) years.

This presentation will greatly help you better prepare for and manage an FDA inspection in a proactive and effective manner.

The speaker will also discuss practical, actionable, and sustainable guidance on how to prepare for a sustainable FDA inspection and how to manage the FDA inspection process including Dos and Don’ts before, during and after the inspection.  

This presentation will provide great opportunities to become familiar with the FDA inspection policy and industry’s best GMP practices including the lessons learned from the most common deficiencies observed during the FDA inspections of firms (devices and pharmaceuticals) for the past eight years.

The speaker will share his PASS-IT recommendation/suggestions. 

Areas To Be Covered in this Seminar:


•    Applicable Laws and Regulations
•    FDA Manuals and Inspection Guides
•    Inspection Types and Categories
•    Inspection Classification
•    FDA Forms 482 and 483
•    Common Deficiencies
•    What/How to Prepare for and Manage an FDA Inspection
•    How to Communicate Before, During and After inspection: Dos and Don’ts
•    Inspection Preparation Procedures
•    Recent Trends
•    Responding to 483s, If Issued
•    How to Communicate with Emotional Intelligence
•    Employee Training
•    Actual Case Studies
•    Speaker’s PASS-IT Recommendations

Who will benefit:


•    CEOs
•    VPs
•    Compliance Officers
•    Attorneys
•    Regulatory Affairs
•    Clinical Affairs
•    Quality Assurance
•    R&D
•    Consultants
•    Contractors/Subcontractors
•    Anyone Interested in the FDA Drug Review and Approval Processes

Instructor Profile:

Dr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.us).  As a leading industry speaker, Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. 

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