This Validation of Potency Bioassays training/webinar for Biologicals provides logical approaches that should be implemented during early development to increase predictability and deliver rugged, compliant assays through Phase III and commercialization.
What will Attendees Learn?
Why Should You Attend:
Potency bioassays are a regulatory requirement for all biopharmaceutical products yet validation guidelines are vague due to the large assortment of end points and targets. An additional obstacle is the perceived variability of the methods resulting in unacceptable failure rates due to unreliable accuracy and precision. The seminar also reviews critical validation parameters and uses case studies to highlight common pitfalls and their solutions.What will Attendees Learn?
- Selecting the appropriate bioassay for your product
- Preparation of GMP cell banks
- Maximizing precision and accuracy
- Setting specifications for the validation protocol
- Recognizing differences between Phase I/II and Phase III Validations
- Common pitfalls and solutions
- Case Studies
Who Will Benefit:
- Bioassay and analytical scientists
- Validation specialists
- Project Management
- Regulatory staff
- QA/QC
- Outsourcing Professionals
- Consultants
Course Provider
Ana Menendez,
