Course Information
Course Title: Validation, Verification and Transfer of Pharmaceutical Analytical Methods
Categories: 1 - Liquid Chromatography
2 - Pharmaceutical Sciences
3 - Quality/Regulatory/Compliance
4 - Gas Chromatography
Instructor(s): Gregory Martin Course Number: 49
Affiliation: Complectors Consulting
Course Date: 03/15/2012 - Thursday Course Length: 1 Day Course
Start Time: 08:30 AM End Time: 05:00 PM
Fee: $455 ($655 after 2/13/12) Textbook Fee:

Course Description
This interactive course is designed to provide a life-cycle approach to assuring analytical methods are suitable for their intended use. After an introduction to some of the compendial and regulatory guidance documents on the subject, we will discuss how approaches to method validation change across the life of a product and depend on a variety of situations. The course will then address specific requirements for chromatographic methods intended for monitoring impurities and degradates, chromatographic methods where the focus is on measuring the active ingredient and non-chromatographic methods. For each of these cases, an example of a successful validation will be presented, followed by discussion on how to troubleshoot situations where there are challenges to validation. Upon completion of the course the learner should be able to: 1. describe when it is appropriate to apply method validation, method verification or method transfer principles; 2. discuss the appropriate guidance documents related to method validation, verification and transfer; 3. design and execute method validation experiments; and 4. troubleshoot methods which are not performing well.

Target Audience
Chemists or managers responsible for development, validation, verification or transfer of analytical methods, and regulatory affairs/CMC personnel responsible for filings involving analytical methods.

Course Outline
Contents:
1) Rationale for demonstrating the validity of an analytical method
2) Guidance document related to method validation
a. USP
b. FDA
c. ICH
3) Life cycle approach to method validation
a. Early development
b. Later development
c. Transfer to other laboratories
d. Verification of methods from outside sources, including Compendia
4) Design of validation experiments
a. Chromatographic methods designed to be selective for impurities and degradates
b. Chromatographic methods designed to measure the primary component
c. Non-chromatographic methods
5) Troubleshooting analytical methods
Discussion of examples of methods where validation criteria were not met

Course Instructor's Biography
Greg Martin is President of Complectors Consulting (www.complectors.com) which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. He has particular interest in QbD/Lean approaches to dissolution testing, impurity methods, method lifecycle (development/validation/transfer) and instrument qualification, and is passionate about using good science and sound logic to achieve high quality results, consistent with cGMPs, while minimizing resources. Mr. Martin has over 30 years experience in the pharmaceutical industry and was Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company for many years. In addition, he has volunteered for the USP for over 12 years, and currently serves as Vice Chair of the General Chapters – Physical Analysis Expert Committee, where he is a core member of the Residual Solvents Subcommittee. He is also Chair-elect of the AAPS In Vitro Release and Dissolution Testing Focus Group. He serves on the Editorial Advisory Board of the Journal of Validation Technology and Journal of GXP Compliance. He can be contacted at greg.martin@complectors.com.