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Short Course

Course Information
Course Title: Analytical Method Validation, Verification and Transfer: Using a QbD Approach to Method Lifecycle
Categories: 1 - Liquid Chromatography
2 - Pharmaceutical Sciences
3 - Quality/Regulatory/Compliance
4 - Validation
Instructor(s): Gregory Martin Course Number: 161
Affiliation: Complectors Consulting
Course Date: 03/17/2013 - Sunday Course Length: 1 Day Course
Start Time: 08:30 AM End Time: 05:00 PM
Fee: $480 ($680 after 2/18/13) Textbook Fee:

Course Description
This interactive course is designed to provide participants with an understanding of the requirements for validation, verification and transfer of pharmaceutical analytical methods. A lifecycle approach will be presented to establish the expectations for the method, after which key guidance documents will be reviewed. Different types of methods will be addressed, including those focusing primarily on the active, stability indicating methods and dissolution methods. The similarities and differences between validation, verification and transfer will be discussed and used to formulate protocols which are appropriate to a variety of situations. Establishment of acceptance criteria are a key component of these protocols, and the rationale for selecting criteria will be discussed. Some common issues which arise during these experiments will be discussed, including ways to recognize and address problems.

Target Audience
Chemists (Research, Quality Control, CRO), supervisors, managers or directors from pharmaceutical companies, generic 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
1) Overview of Analytical Method Validation, Verification and Transfer
a. Review of Regulatory, Compendial and ICH Guidance Documents
2) A QbD Framework for Analytical Method Lifecycle
a. Method Design
i. Analtyical Target Profile
ii. Method Development
iii. Method Understanding: Method Operational Space
iv. System Suitability
b. Method Qualification
i. Method IQ (Facilities)
ii. Method OQ (Validation)
iii. Method PQ (Real Samples)
c. Continued Method Verification
i. Change Control
ii. Method Transfer
iii. Method Verification
3) Correlating This Approach with Compendial Requirements
a. Validation, following ICH Q2 and USP <1225>
i. Stability Indicating Chromatographic Method with Degradates/Impurities
ii. Chromatographic method for Major Component
iii. Non-chromatographic methods
b. Verification of Compendial Methods
c. Transfer of Analytical Methods Between Laboratories
d. When to do validation, verification and transfer apply?
4) Practical Considerations
a. Designing Validation Experiments to minimize time and resources
b. Sensible pre-validation experiments
c. Writing validation protocols and establishing practical acceptance criteria
d .Writing validation reports
e. Troubleshooting unexpected results

5) Attendee 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. 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 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 as Vice Chair of the General Chapters – Physical Analysis Expert Committee, and serves on Expert Panels on Validation and Verification, Weights and Balances and Use of Enzymes for Dissolution Testing of Gelatin Capsules. He is also Chair-elect of the AAPS In Vitro Release and Dissolution Testing Focus Group. He can be contacted at greg.martin@complectors.com.