San Francisco Professional Events List

Implementing a Compliant Stability Program for Biologics

Jun 05, 2019 - 10:00 AM
Netzealous LLC DBA - Compliance4All
161 Mission Falls Lane, Suite 216,,

ZIP: 94539
Phone: 8004479407

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

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: [email protected]

Event Categories
Keywords: Educational, Health


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