2019 - Implementing a Compliant Stability Program for Biologics

Overview:
Biologics, as well as small molecule pharmaceutical products, require expiry dating.The complex structure of large molecules presents greater opportunities for degradation. Biologics may lose identity by cleavage ultimately resulting in loss of potency.
Why should you Attend:
To collect data that supports expiry dating, the drug substance and the drug product must be thoroughly tested in stability indicating methods. Understanding the importance of these methods and the analysis and interpretation of the data is necessary for personnel involved in product development, product testing, and product release.
Areas Covered in the Session:
Testing CQAs
Stability Indicating Methods
Test conditions, including stress conditions
Data requirements
Considerations for expiry dating
Who Will Benefit:
Laboratory Scientists
Laboratory Managers
Quality Assurance Specialists
Quality Control Specialists
Speaker Profile:
Gwen Wise-Blackman, Ph.D. has over 20 years of combined experience in Cell-Based Assays and Quality Systems. She has worked at DuPont Pharmaceuticals, Catalent Pharma Solutions (formerly Magellan Laboratories and Cardinal Health), and Salix Pharmaceuticals where she successfully managed multiple projects and held positions of increasing accountability for scientific and quality expertise.
Event Fee: One Dial-in One Attendee Price: $150.00
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: compliance4all14-AT-gmail.com