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Forced Degradation Studies/ Biologics Stability Programs for Biopharmaceuticals

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This 90-minute training will provide you with an overview of a forced degradation study on a protein therapeutic and help you interpret and leverage the results to design stability studies required for registration of the BLA.

Speaker
Instructor: Nanda Subbarao
Product ID: 701748
Training Level: Intermediate to Advanced

Why Should You Attend:

A comprehensive forced degradation study is essential for design of an analytical program which when implemented right from the initial stages of a project will result in right-first-time CMC data package and therefore lead to cost savings in terms of analytical lab and regulatory department resource requirements. The forced degradation results must be incorporated in the design of the compliant stability program which is essential for the success of a well characterized protein product.

This 90 minute session is designed to provide the attendee with an overview of a forced degradation study on a protein therapeutic and to interpret and leverage the results to design the stability studies required for registration of the BLA. The speaker will address the stress conditions typically used to study the tendency of the protein to undergo degradation along with the analytical methods required for the study. Forced degradation study data must be utilized during the design of the stability program. We will discuss how you can leverage the forced degradation results to design stability studies for the drug substance and drug product. The regulatory requirements for such studies will be addressed.

Areas Covered in the Webinar:

Who Will Benefit:

Instructor Profile:

Dr. Nanda Subbarao holds a Ph.D. in Bio-organic Chemistry. Her hands-on industrial experience covers stability and laboratory cGMP systems for both biologics and conventional drugs. She has extensive experience in evaluation of analytical methods and method validation for products ranging from conventional drugs, well characterized proteins, vaccines, cell therapy and gene therapy products, ranging from pre-clinical phase to commercial phases. She has extensive expertise in setup of cGMP/GLP complaint quality systems for laboratory and stability programs as well as upgrade of existing quality systems for products during development and in commercial phases. She is currently a senior consultant with the Biologics Consulting Group specializing in analytical, stability, CMC and GLP/GMP quality systems. She serves on the AAPS Stability Focus Group Steering Committee as well.

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Refund Policy
"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 only 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."
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Training Options Training Duration = 90 Min
Attend Live Online Training Only
February 25, Wednesday 10:00 AM PST | 01:00 PM EST
$249.00 One Dial-in One Attendee
$999.00 Group–Max. 10 Attendees/Location
(For multiple locations contact Customer Care)