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Date: 26th - 28th August, 2008

Location: web seminar, USA

Summary:
Clinical, Cosmetic, Pharmaceutical, Water - Seminar

One of the most critical factors in developing pharmaceutical drug substances and drug products today is ensuring that the analytical methods used generate meaningful data. The FDA, USP, and ICH have all recognized the importance of analytical method validation to the drug development process, and have thus increased method validation requirements in recent years. Both systematic approaches to method development, as well as the theory behind the validation process, will be discussed and exemplified by applying the principles to HPLC method development. Some of the more common mathematical and statistical treatments of validation data will be presented.

Upon completion of this course, participants will have a clear understanding of how analytical method development and validation is conducted, and what regulatory agencies expect regarding validation. Participants will gain a better understanding of what elements are needed to effectively design development and validation programs, what is required in writing protocols and reports, and how to set reasonable acceptance limits for validations. Finally, participants will learn how to avoid common validation pitfalls.

Points to be Covered:
Session 1 (August 26, 2008)
Systematic Approach to Method Development
Setting goals
Selecting a starting point
Tuning the method
Checking for problems
Critical components of a method
Improving robustness

Session 2 (August 27, 2008)
Regulatory Guidance
Method Validation
Critical Validation Parameters
Validation Tests
Setting Acceptance Limits

Session 3 (August 28, 2008)
Method Validation
Method Validation Protocol
Method Validation Report