Stability Testing for Protein Drug Products & Substances

July 13, 2015

CfPA-The Center for Professional Advancement, Burlingame, CA
October 8-9, 2015

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.

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.

Maximize Your Learning!
Attend this course and its Companion Course:
Global QA/QC for Biopharmaceuticals, Vaccines and Other Biologics
October 6-7, 2015 • Burlingame, CA • Course ID #2535

Organized by:

CfPA-The Center for Professional Advancement

Invited Speakers:

Thomas J Pritchett, Ph.D., Consultant

Thomas J Pritchett, has worked with the US, European, and Canadian pharmaceutical, biopharmaceutical, and biologics industries for more than 25 years, during which he has gained considerable experience in regulatory and technical aspects of Quality Assurance, Quality Control and CGMP Compliance for both investigational and marketed products. He is also an experienced teacher, and has been directing courses for the Center for Professional Advancement since 1995. In addition, Dr. Pritchett has provided training sessions for the US FDA, for regulators and industry professionals in the Gulf Cooperation Council (GCC) and at the National Institutes of Health. Dr. Pritchett is also an active industry consultant and the co-founder/publisher of the newsletter BioQuality (www.bioquality.biz). He sits on the editorial advisory board of BioProcess International.

Deadline for Abstracts:

n/a

Registration:

Please click here for registration information.

E-mail:

sberg@cfpa.com

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