Short Course Listings
 
Short Course

Course Information
Course Title: Developing, Validating and Troubleshooting Dissolution Methods
Categories: 1 - Liquid Chromatography
2 - Pharmaceutical Sciences
3 - Quality/Regulatory/Compliance
4 - Validation
Instructor(s): Gregory Martin Course Number: 164
Affiliation: Complectors Consulting
Course Date: 03/20/2013 - Wednesday 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 practical tools for those developing dissolution methods at various stages (including biorelevant methods), and to provide an understanding of the development process for managers, formulators and regulatory affairs/CMC personnel Building on the history of dissolution, the learner is presented with a systematic approach for developing dissolution methods. Validation and transfer of methods is also addressed. The course emphasizes troubleshooting methods, when changes in dissolution profiles are observed, and understanding the causes for those changes, with ample opportunities to discuss real or hypothetical situations. The topics of correlations between dissolution and in vivo data (IVIVC) and setting specifications are then introduced. Next, several key regulatory and compendial documents are discussed to assist the learners in connecting regulatory expectations with their methods. This leads into a discussion on dissolution instrument qualification. Finally, there is ample time for discussion of learner challenges and questions.

Target Audience
Chemists (Research, Quality Control, CRO) involved with dissolution method development or testing and their managers, formulators who rely on dissolution data and regulatory affairs/CMC personnel responsible for filings involving dissolution.

Course Outline
1) History of Dissolution and the Compendial Apparatus
a. Qualification of Dissolution Apparatus
2) A Practical Approach to Method Development
a. Using a QbD Approach to Method Lifecycle
b. Early phase
c. Biorelevant
d. Late phase
e. Setting Specifications
f. Interactive examples
3) Validation of Dissolution Methods
a. Verification of methods
b. Transfer of methods
4) Method Troubleshooting
a. Method Robustness
b. Differences Among Potencies
c. Impact of Stability
d. Lot-to-Lot Variability
e. Participants' Challenges
6) Regulatory and Compendial Documents
7) 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.