FDA Rules for Pharmaceutical Analytical Method Validation webinar

  • Instructor : Dr. Loren Gelber
  • Level : Intermediate
  • Study time : 43 minutes
  • Course ID: TF2952
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ABOUT THE COURSE

Do your method validation reports meet current FDA expectations?
Could your verification of compendial methods withstand an inspection?
Are you fully clear on the difference between validation and verification?


If you’re responsible for method development, validation, or review—this training is your blueprint to getting it right the first time and avoiding FDA red flags.


WHAT WILL YOU GAIN
  • Step-by-step clarity on FDA expectations for method validation and verification
  • Ability to define, document, and defend analytical specifications with precision
  • Strategies to reduce deficiencies in method validation reports and lab audits


WHY TAKE THIS COURSE
  • Prevent method-related 483s and submission rejections
  • Improve team consistency across analytical reporting and documentation
  • Use practical insights to meet both CGMP and submission requirements


KEY AREAS COVERED
  • Validation vs. verification—when each applies and why it matters
  • FDA expectations for method specificity, accuracy, and precision
  • Establishing and documenting analytical performance characteristics
  • Managing sensitivity, linearity, and range in your method process
  • Best practices for robustness and reproducibility in pharma labs
  • Order of validation activities and critical points of failure to avoid

Quality training, expert insights, and answers that matter. Know your Expert

Dr. LOREN GELBER

With over 40 years in regulatory compliance and a former FDA reviewer in the Division of Generic Drugs, Dr. Loren Gelber brings unmatched insight into pharmaceutical validation. Having served across top pharma companies and now consulting independently, she translates FDA expectations into practical, real-world steps that help scientists stay inspection-ready and submission-smart.

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