Who Should Attend
This three-day course is designed for management and professional staff involved in, or interested in quality assurance (QA) and quality control (QC) support for biologics and biopharmaceuticals. This course will be of particular interest to QA and QC personnel (lower-level and management), Regulatory Affairs, Manufacturing, Process Development and Analytical Development staff, and anyone involved with the biologic and biopharmaceutical industry.
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
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.