FDA Rules for Pharmaceutical Analytical Method Validation

Duration 60 Mins
Level Intermediate
Webinar ID IQW19D0410

  • General Information
  • Specificity
  • Accuracy
  • Precision
  • Sensitivity
  • Linearity
  • Range
  • Robustness
  • Reproducibility

Overview of the webinar

FDA Current Good Manufacturing Practice requirements include that validation of non-compendial analytical methods and the verification of compendial methods. The various aspects of validation or verification will be discussed, including the order in which they should be conducted and establishing specifications for success.

Who should attend?

  • Analytical Method Development Supervisors
  • Analytical Method Validation Supervisors
  • Method Research Chemist
  • Analytical Chemists
  • QC and R&D Laboratory Supervisors
  • Regulatory Affairs Supervisors

Why should you attend?

All chemists involved in the development and validation of analytical methods, those who supervise them and those who review or submit their method validation reports must know about the FDA rules for method validation. Defects or absence of validation or verification of analytical methods are frequent observations of FDA application reviewers and deficiencies during FDA inspections. Learning how to minimize these problems is highly recommended.

Faculty - Dr.Loren Gelber

Dr. Loren Gelber has more than 40 years in the pharmaceutical industry. She spent her first ten years at FDA, followed by 20 years in Regulatory Affairs and Compliance at various pharmaceutical companies, and the last ten years as a Regulatory Compliance Consultant. During this time she was a member of various groups and committees that worked on many compliance issues. She has published a number of papers and delivered various seminars and talks. Dr. Gelber holds a BA in Biology from Brandeis University, an MS in Chemistry from Brooklyn Polytechnic Institute (now part of NYU) and a PhD in Medicinal Chemistry from Northeastern University School of Pharmacy and Allied Health Professions. She current resides in Charlotte, NC.

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