On-Demand Seminar: Academic Research Versus GMP Industry

The guidelines pertaining to academic research and GMP serve two different purposes. The protocols for the former are designed to protect scientific data integrity, and to provide the regulatory bodies with a clear and auditable record of open-ended research studies. In contrast, the regulations for the latter are intended to demonstrate whether or not individual batches of a regulated product are manufactured according to pre-defined manufacturing criteria.

Watch Kris Wronski, Applications Scientist at Thermo Fisher Scientific, highlighting the salient differences between academic research and the GMP industry, the challenges faced by both and how our capabilities can support each group.

The seminar covers the following topics:

• How academic research differs from the GMP industry
• The rules for documentation and record keeping
• The implications of quality management and training
• The importance of sample management, lab facilities and contamination risks, and equipment and maintenance