Stability Testing for Protein Drug Products & Substances

July 07, 2017

CfPA-The Center for Professional Advancement, New Brunswick, NJ
October 30-31, 2017

Who Should Attend?
This course is designed to serve the needs of professionals working on Innovator and Biosimilar Protein and Peptide stability during development, for approval, and for postmarketing studies. Because of its comprehensive content, this course will be valuable to personnel in
  • Stability departments
  • Research and Development
  • QA and QC
  • Regulatory Affairs
  • Production

Professionals who are involved in planning, conducting, reviewing, supervising, or managing stability testing activities to determine shelf lives and retest dates of pharmaceutical proteins and peptides would benefit greatly from this training.

RAPS - Regulatory Affairs Professional Society
This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's recertification of their Regulatory Affairs Certification (RAC) upon full completion.

Course Description

This 2-day intensive course provides comprehensive and up-to-date knowledge of developing and executing compliant and effective stability programs for protein and peptide biopharmaceuticals and biologics. The course covers both US FDA and EU EMA regulatory and technical expectations and activities to fulfill those expectations, with the guidelines of the International Conference on Harmonization (ICH) receiving special attention. The approach of the course is practical as well as theoretical so that attendees will be able to plan, accomplish and review stability studies and programs. Attendees will have the opportunity to apply what they have learned during a workshop in which participants join the instructor in planning model stability programs for relevant product types.

Organized by:

CfPA-The Center for Professional Advancement

Invited Speakers:

Dr. Pardeep K. Gupta; Professor of Pharmaceutics, Philadelphia College of Pharmacy, University of The Sciences in Philadelphia (USP)

Dr. Pardeep K. Gupta is a Professor of Pharmaceutics in Philadelphia College of Pharmacy at the University of The Sciences in Philadelphia (USP). He received his B. Pharm. and M. Pharm. (pharmaceutical chemistry) degrees from India. He also received a M.S. degree in medicinal chemistry from USP and his Ph.D. in pharmaceutics from University of Wisconsin. His research interests include delivery of proteins and peptides and study of the interaction of drugs with biomembranes. He has published several articles and has authored several book chapters. His teaching responsibilities include courses in solubility, controlled drug delivery and drug stability at the graduate level. He is on the editorial board of Remington: The Science and Practice of Pharmacy, and is the editor of Pharmaceutical Chemistry and Pharmaceutical Testing, Analysis and Control sections of the book.

Deadline for Abstracts:

n/a

Registration:

Please click here for registration information.

E-mail:

jmorbit@cfpa.com

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