Excipient Significant Change Workshop
Tuesday March 23, 2010

Workshop Leader
R. Christian Moreton, Ph.D.

Description:
An effective Change Control system should be part of the quality system used by the excipient manufacturer. Some key concepts covered in this workshop are understanding the impact of a change on an excipient and its use, evaluation of the change, and understanding the reporting requirements and customer expectations. This course includes a review of the IPEC Significant Change Guide 2009.

Course Outline:

• Introduction to Excipients (Incl. Types, Sources, Variability)
• Changes in Excipients (Manufacturing, Additives, Specs, Documenting)
• Change from the Manufacturer’s perspective
• How to evaluate the impact of the change on the customer.
• Change from the User’s perspective (Risks analysis)
• Making it work (Confidentiality, Change control, Communication)

Validation Workshop
Wednesday March 24, 2010

Workshop Leader
Sidney A. Goode, PharmD

Description:
Validation is the key element in assuring that quality assurance goals are met and a consistent excipient quality is regularly achieved.The scope of this workshop includes removing some of the misunderstanding and preconceptions concerning validation.

Course Outline:

• Basic Explanation of Validation
• Purpose and Gains of Validation
• Compliance Requirements
• Validation Planning and Resources
• Issues to be addressed
• Validation Master Plan
• Validation Protocol preparation
• Implementing protocol and collection of data
• Interpretation and analysis of the data
• Management of changes
• Addressing re-validation
• Writing the final report