BIOTECH 2012 - Life Cycle Validation of GMP Potency Bioassays

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Category GMP Potency Bioassays, Life Cycle Validation, bioassay selection, bioassay optimization, bioassay validation, biopharmaceutical methods validation, product development.

Deadline: February 09, 2012 | Date: February 09, 2012

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

Updated: 2011-12-08 19:56:04 (GMT+9)

Call For Papers - CFP

Why Should You Attend:

Potency bioassays are an integral part of release testing and stability studies for biotechnological products. There is a lack of clarity of how much work is required at each development phase to maintain scientific rigor and meet regulatory expectations.

Areas Covered in the Seminar:

- Rational approaches to bioassay selection and optimization.

- Effective transition of bioassays from early to late stage product development.

- Strategies to increase accuracy and repeatability.

- Techniques to avoid common technical problems.

- Guidelines for bioassay validation and regulatory documentation.

- Steps for preparing a method for technology transfer and commercial validation.

- Implementation of USP 1032, 1033 and 1034.

Who Will Benefit:

The following personnel from biotech and pharmaceutical companies and laboratories will benefit:

- Bioassay and analytical scientists

- Validation specialists

- Project Management

- Regulatory staff

- QA/QC

- Outsourcing Professionals

- Consultants