Analytical Methods Validation for FDA Compliance
This course is intended for individuals who have the responsibility for establishing the integrity of analytical methods for active pharmaceutical ingredients (APIs) or finished pharmaceutical dosage forms. This course will benefit individuals in:
- Event Type:
- Workshops/Training Courses
- Oct. 17-19, 2016
- Burlingame , CA , USA
• Quality Control
• Quality Assurance
• Technical Operations
Regulatory affairs personnel responsible for the review of such data will also benefit from this course.
RAPS - Regulatory Affairs Professional Society
This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's recertification of their Regulatory Affairs Certification (RAC) upon full completion. Course Description
Whether involved in method development, method validation, method verification or method transfer, this 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.
Although the general principles in this course may be applied to methods for testing biological molecules and medical devices, the focus of this course is on the validation of methods for the analysis of small molecules and not the unique analytical procedures often used for testing products of a biological nature.