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  • FDA Inspection Preparation and Management: Dos and Don'ts

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Wednesday - Feb 12, 2014 10:00 AM
  • End Time:
  • Wednesday - Feb 12, 2014 11:00 AM
  • Location:
  • Online
  • This training will provide the attendees best practices for preparing and managing FDA inspection process including dos and don’ts before, during and after the inspection. Learn how to respond to Form 483 citations, Warning Letters.

    Why Should You Attend:
    Regardless of whether your company has been at the receiving end of a regulatory action or not, this course will help you to be better prepared for an FDA inspection and effectively manage and respond to FDA inspections.
    This webinar will provide emotional intelligence (EQ)-based practical, actionable, and sustainable guidance on how to proactively prepare for an FDA inspection and also to adequately manage the FDA inspection process including Dos and Don’ts before, during and after the inspection. This training is further intended to discuss and understand FDA’s inspection authority, inspection process, and FDA’s compliance programs.
    This 60-min webinar will provide great opportunities to get better familiar with an FDA inspection and to greatly improve your awareness so that you would better prepare for and confidently manage all FDA inspection-related matters.

    Areas Covered in the Webinar:
    -Statutes and Regulations
    -Field Management Directives
    -Investigations Operations Manual (IOM)
    -Inspection guides
    -Compliance Program Guidance Manual (CPGM)
    -How to host an FDA inspection
    -Inspection types and categories
    -Inspection classification
    -Inspection process
    FDA Forms 482 and 483
    -Inspection response
    -What/How to prepare for and to manage an FDA inspection
    -How to communicate before, during and after inspection: Dos and Don’ts
    -Case studies

    Who Will Benefit:
    -Regulatory affairs (associates, specialists, managers, directors or VPs)
    -Quality professionals (associates, specialists, managers, directors or VPs)
    -R&D (engineers, scientists, managers, directors or VPs)
    -Complaint and risk management personnel
    -Clinical affairs (associates, specialists, managers, directors or VPs)
    -Other interested parties

    Instructor Profile:
    Dr. David Lim, Ph.D., RAC, ASQ-CQA is President and Principal of Regulatory Doctor ( Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, he 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 seven years.


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