Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. . 

Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.

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Implementing a Compliant Stability Program for Biologics

Start Date : June 5, 2019
End Date : June 5, 2019
Time : 10:00 am to11:30 am

Phone : (800) 447-9407
Email : compliance4all14@gmail.com

Description

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@gmail.com

Organized by

Organized by compliance4all14

Netzealous LLC DBA - Compliance4All ,
161 Mission Falls Lane, Suite 216,

Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. . 

Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.

Tel: 800-447-9407
Mobile: 8004479407
Email: compliance4all14@gmail.com
Website: http://www.compliance4all.com/


Event Categories: Health & Nutrition.




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