Implementing a Stability Program for a Biologic
Instructor:
Gwen Wise Blackman
Product ID: 705696
- Duration: 90 Min
Why Should You Attend:
It is must that drugs delivered to patients maintain established potency and efficacy within specified time windows and hence all drug substances/products require expiration dating. The process of data collection & analysis to support , expiry and self life need to be different for large molecules compared to small molecules as the complexity of large molecule therapeutics allows for a greater potential to lose potency through multiple pathways. This can occur during manufacture, transit, or storage.
This webinar addresses issues present when designing and implementing a stability program for large molecule therapeutics. Key topics will be addressed to provide insight into important issues that should be considered to assure maintenance of potency during shelf life of the product.
Areas Covered in the Webinar:
- Defining biologics - the difference between stability for small molecules and large molecules or complex drug products
- Degradation pathways
- Areas of concern for loss of stability
- Setting strategy to control stability
- Testing CQAs
- Stability Indicating Methods – Design and Validation
- Test conditions, including stress conditions
- Data requirements
- Considerations for expiry dating
Who Will Benefit:
- Early Development and Product Design Personnel
- Process Design Personnel
- Quality Control Analyst
- Quality Assurance Personnel
- Lab Management
- Stability Personnel
- Manufacturing Personnel
- Shipping and Distribution Personnel
- Regulatory Affairs
- Drug Packaging Personnel
Gwen Wise Blackman
Manager, Salix Pharmaceuticals
Gwen Wise-Blackman, Ph.D. has 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. Currently she is the owner of Gwen Wise-Blackman Consulting, LLC, a biopharmaceutical consulting firm. Her focus has been in High-Throughput Screening, Cell-Based Assay Method Development and Validation, Ligand Binding Methods, Technology Transfer, GxP Regulations, and Quality Assurance. Dr. Wise-Blackman has a Bachelor of Science degree in biology from M.I.T and a PhD in Pharmacology from the University of Virginia. She is a member of ASQ and AAPS.
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
