At the end of the course you will:

• Understand the critical importance and underlying principles for the QA/QC of biologics and biopharmaceuticals, and know how these principles differ from those for chemical-origin drug products
• Be able to develop a cost-effective, risk-managed QA/QC strategy to move these products through clinical development and into commercialization, including establishing effective inter-company quality agreements with outsourced contractors
• Have the tools and understanding necessary to adequately address biosafety (adventitious agents), potency (biological functioning bioassays) and impurity profile issues for biologic and biopharmaceutical products; and how to set appropriate and adequate product specifications and expiration dates

Course Description

While there are considerable similarities between biologics/biopharmaceuticals and chemically-synthesized drug products, many of the QA/QC issues and challenges are significantly different.  Biology-based drug products are more complex products, derived from potentially changing living sources that are highly susceptible to contamination with adventitious agents such as prions, viruses and mycoplasmas. Process-related impurities in biologic/biopharmaceutical products raise concern not only of potential toxicity but also of tumorigenicity and immunogenicity. Furthermore, unlike many chemically-synthesized drug products, the manufacturing process itself can impact both the potency and the immunogenicity of biologic/biopharmaceutical products.

This landscape for biologic and biopharmaceutical products, coupled with ongoing changes in regulations and expectations, makes it extremely important for a company to have an effective QA/QC risk management strategy for each stage of drug development, from Phase 1 clinical trials through market approval.       

This course highlights the challenges and pressures facing QA/QC in today’s biologic and biopharmaceutical environment, and presents the strategic importance and value generated by QA/QC for their involvement in control of the manufacturing process, and testing and release of these products. QA/QC regulations and guidances from the U.S. FDA, EMEA and ICH are discussed in detail.



View Course Agenda



Past Participants' Comments

"The course was very effective in presenting regulatory issues. The instructor was very knowledgeable and discussed real-life situations."
Steve R., Drug Information Specialist, Organon

“The Course Director put a great deal effort into producing an outstanding course. I would recommend this course to all of my colleagues.”
Jeffrey M., Sr. Information Technology Analyst, Biogen Idec

“The fact that this company limits the class size allows the Course Director to tailor the material to those in attendance. It was obvious that a lot of preparation went into addressing our needs. Needless to say, the instructor was very experienced and did a great job.”
Amy C., Genentech

"Probably the most specifically appropriate and pertinent course I have ever attended"
Senior Drug Information Manager, Bristol Myers

"This course was much better than others I attended and I would strongly recommend this course to others."
Dr. Shahid A., VP of Research & Development, NeoPharm Inc.