Analytical Method Validation for Pharmaceuticals
Dr. Loren Gelber has more than 40 years of experience in pharmaceutical industry regulatory compliance. She worked for about 10 years at the FDA, including as a reviewer in the Division of Generic Drugs. As an early user of HPLC, she was involved in establishing the FDA requirements for the validation of HPLC methods, and she published the results of her validations both within FDA and externally.
She then transitioned to industry, working for four different pharmaceutical companies. She has participated in many FDA inspections, often as the lead person from the pharmaceutical firm. For the last 13 years, she has been a regulatory compliance consultant, both for consulting companies and independently.
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.
- General Information
Course Level - Intermediate
Who Should Attend
- Analytical Chemists
- QC and R&D Laboratory Supervisors
- Regulatory Affairs
Why Should 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 is frequent observations of FDA application reviewers and deficiencies during FDA inspections. Learning how to minimize these problems is highly recommended.