Avoiding FDA observations: Do's and Don'ts during Laboratory Inspections

Instructor: Kim Huynh-Ba
Product ID: 703278
  • Duration: 60 Min
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This training will provide the attendees best practices for handling FDA inspections to avoid form 483 and Warning Letters.

Why Should You Attend:

Most of the activities during an inspection traditionally may be handled by the quality assurance group; however, more and more often, technical personnel are needed to address questions from regulatory agencies. Therefore, handling an inspection is a very critical activity. Clear and concise presentation of information will aid the regulatory agency in their review.

This webinar will discuss the important structure of a regulatory agency’s inspection and the key behaviors needed to ensure that appropriate information is presented. Proper recordkeeping and documentation will be discussed as will how best to cite and prepare summaries of the observations.

Areas Covered in the Webinar:

  • Determine the sequences of an inspection
  • Good recordkeeping for GMP and non-GMP studies
  • Establish a process of handling an inspection
  • Presenting clear and concise information
  • Train your personnel to handle an inspection
  • Keep clear and concise records of observations

Who will Benefit:

  • Regulatory Affairs
  • Quality Assurance/Control
  • Analytical Chemists
  • Auditing
  • Scientists
  • Research & Development
  • Quality Systems Management
  • Documentation Management
  • VPs, Directors and Heads of: Quality Assurance, Compliance, Validation & Regulatory Affairs

Instructor Profile:

Kim Huynh-Ba, has almost 25 years of experience in analytical development, project management, strategic drug development and stability sciences. She currently is the Executive Director of Pharmalytik, where she provides consulting and training services to pharmaceutical companies, including companies operating under FDA’s Consent Decree on harmonization and optimization of analytical best practices since 2003. Prior to Pharmalytik, she was the Director of Pharmacopeial Education Department of U.S. Pharmacopeia (USP), where she was responsible for their education programs worldwide. Kim is also a short course instructor on cGMP compliance and quality topics for several global organizations such as ACS, AAPS, Pittsburgh Conference, and many other international training groups. She is an Adjunct Professor at Temple University-School of Pharmacy, Widener University and Illinois Institute of Technology (IIT) teaching pharmaceutical analysis and analytical chemistry graduate courses.

She is a member of the Executive Committee of Governing Board of Eastern Analytical Symposium (EAS) and was their 2013 President. She is the Chair of USP Good Documentation Practices Expert Panel and a member of USP Impurities of Drug Products Expert Panel.

She has authored numerous technical publications and book chapters and has spoken extensively, both domestic and internationally, of the compliance and quality areas. She is the editor of the “Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices” (2008) and “Pharmaceutical Stability Testing to Support Global Markets” (2010).

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