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Short Course

Course Information
Course Title: Lifecycle Approach to Analytical Methods for Drug Products: Design, Qualification, Continuing Verification
Categories: 1 - Liquid Chromatography
2 - Pharmaceutical Sciences
3 - Quality/Regulatory/Compliance
4 - Validation
Instructor(s): Greg Martin Course Number: 123
Affiliation: Complectors Consulting
Course Date: 03/08/2017 - Wednesday Course Length: 1 Day Course
Start Time: 08:30 AM End Time: 05:00 PM
Fee: $575 ($775 after 2/18/17) Textbook Fee:

Course Description
This highly interactive course is designed to provide participants with a lifecycle approach to developing and validating analytical methods, including elements aligned with QbD concepts. By using a lifecycle approach, methods are more likely to meet their intended purpose, and scientists are more likely to have success during validation and transfer exercises. The course will build on traditional concepts of method development, validation and transfer by introducing the Analytical Target Profile (which identifies what the method is expected to accomplish), fostering method understanding (using QbD concepts of Risk Assessment and Control Strategy, and stressing the importance of real samples in the environment where they will be tested) and demonstrating how these principles can be used iteratively as methods change location or evolve technically. This approach will be linked with current compendial requirements. There will be ample opportunity for questions and interaction throughout the course.

Target Audience
Chemists, supervisors, managers or directors from pharmaceutical (human and veterinary), generic or OTC companies or contract research organizations who are responsible for development, validation, verification or transfer of analytical methods, and regulatory affairs/CMC personnel responsible for filings involving analytical methods

Course Outline
•Introduction: Using a Lifecycle Approach for Pharmaceutical Analytical Procedures
•Method Design: Introducing the concept of the Analytical Target Profile
o What is an Analytical Target Profile?
o ATP for Assay or uniformity, Dissolution or Stability indicating methods
o PRACTICAL EXERCISE: Develop an ATP for a stability indicating method
o Risk Assessment and development of a Control Strategy
•Method Qualification
o Rationale for demonstrating the validity of an analytical method
o Life cycle approach to method validation
o Applying the concepts of ICH Q2 and USP <1225>
o Design of validation experiments
- Establishing acceptance criteria
o PRACTICAL EXERCISE: Designing a validation protocol
•Continuing Verification of Analytical Methods
o Method Modifications: Change control and method revalidation strategies
o Verification of Compendial Procedures
o Method Transfer
o Troubleshooting analytical methods
•Questions and discussion

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. Mr. Martin has over 25 years experience in the pharmaceutical industry and was Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company for a number of years. In addition, he has volunteered for the USP for over 10 years, and currently serves on the General Chapters – Chemical Analysis Expert Committee, and serves on Expert Panels on Validation and Verification, Residual Solvents and Use of Enzymes for Dissolution Testing of Gelatin Capsules. He has particular interest in QbD/Lean approaches to dissolution testing, impurity methods, method lifecycle (development/qualification/continuing verification) 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 is author of several papers in the areas of dissolution and analytical method validation, and is past chair of the AAPS In Vitro Release and Dissolution Testing Focus Group. He can be contacted at greg.martin@complectors.com.