Biotech 2012 - Life Cycle Validation of GMP Potency Bioassays

This 90-minute webinar will provide guidelines for bioassay validation and regulatory documentation, the steps for technology transfer and commercial validation show how to implement the new USP chapters 1032, 1033 and 1034.
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