Making the goods: Cleanliness, orderliness, scaling and other considerations.

A presentation by Gayle Piat (Alberta Cell Therapy Manufacturing Facility) and Friederike Pfau, PhD (Laboratory of Experimental Organogenesis, University of Laval) at the Bench to Bedside for Biotherapeutics (B3) Workshop held in Toronto on October 5, 2017.

In this seminar, Gayle Piat discusses Good Manufacturing Practices (GMP) and how to transition from a research lab environment to a GMP Facility. This seminar focuses on understanding what being GMP implies, understanding the difference between Quality Assurance (QA) and Quality Control (QC) as well understanding Quality Management Systems and the importance of record keeping. Next, Dr. Pfau delves deeper into understanding the realities of GMP Clean Rooms, how these facilities work to control air and reduce contamination as well as establishing and implementing operating and equipment handling procedures and lastly how to deal with changes.

This video is presented by the Clinical Translation Education Group:  BioCanRx, CCRM, CellCAN, Foundation Fighting Blindness, Ontario Institute for Cancer Research, Ontario Institute for Regenerative Medicine and Stem Cell Network.

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