BIOTECH 2012 - Implementation of the USP GMP Potency Bioassay Suite

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Category Revised USP 111; USP GMP Potency Bioassay Suite; Potency Bioassays; regulatory requirements; USP Bioassay suite; USP 1032; USP 1033; USP 1034

Deadline: January 26, 2012 | Date: January 26, 2012

Venue/Country: Palo Alto, U.S.A

Updated: 2011-12-08 19:49:54 (GMT+9)

Call For Papers - CFP

Why Should You Attend:

Potency bioassays are a regulatory requirement for release and stability testing of all biopharmaceutical products. Guidelines have remained vague on bioassay expectations due to the large assortment of mechanisms, end points and targets required for these assays. An additional obstacle is the perceived variability of the methods resulting in unacceptable failure rates due to unreliable accuracy, precision and parallelism expectations. The draft USP Bioassay suite consists of the following new chapters: USP 1032, 1033 and 1034). These chapters will be finalized soon and are already being accepted as a coherent data-driven approach to develop, analyze and validate potency assays.

Areas Covered in the seminar:

- Step by step guide to interpreting new USP Bioassay suite.

- Review current expectations for parallelism.

- Decrease failure rate for precision and accuracy.

- Set specifications for the validation protocol and sample analysis.

- Recognize differences between Phase I/II and Phase III Validations.

- Case Studies.