By J. Mark Green
Published in: CFPA Course
Published on: November 1, 2023
Whether involved in method development, method validation, method verification or method transfer, this 18 hour ON DEMAND accredited course will provide a broad understanding and “hands-on” knowledge of the method validation process and the difficulties encountered in validating methods to comply with today’s upgraded FDA CDER requirements. Lectures will include not only theoretical basis and practical applications, but actual validation examples of HPLC, GC, UV/Vis, AA and titration methods for small organic molecules. Some of the more common mathematical and statistical treatments of validation data will also be discussed. Because of the tremendous effort that can be expended in conducting validation studies, efficiency of experimental design and documentation will be stressed throughout the discussions.
Authorities • Change Control • Compliance • Guidances • Methods • Pharmacopoeia • Quality • Regulations • Regulatory • Testing
