June 8, 2021
9:00 am - 12:00 am
CAD $485 + HST
Health Canada Guide 0069, Temperature Control of Drug Products during Storage and Transportation requires drug products to be transported, handled and stored in a manner that mitigates the risk of exposure to temperatures outside labelled storage conditions; potentially impacting the safety, quality and effectiveness of the drug product, fabricators, packagers/labelers, distributors, importers and wholesalers are additionally responsible for the appropriate handling, storage and distribution of drugs according to C.02.015 of the Food and Drug Regulations. Other Regulatory bodies such as the FDA also require the temperature of storage areas to be maintained in accordance with labelled storage conditions in order to maintain drug safety, quality and efficacy.
GMP Temperature Mapping should be completed on a periodic basis, in order to demonstrate continuing compliance. Temperature Mapping should also be completed when significant changes have been made to the equipment and storage areas which could impact air circulation or loading or unexplainable variability in temperature occurs outside of the specifications.
Temperature mapping is not only a regulatory requirement for your rooms or equipment. It is also a source of data you could rely on when it will be time to install your real time monitoring system. And help you to better understand how your products could be impacted by temperature deviations and take then appropriate decisions.
This webinar will assist Companies in understanding the Regulatory requirements for conducting a GMP Compliant Temperature Mapping of their facility. Participants will learn how to complete a risk assessment, document a Temperature Mapping Protocol and a Summary Report.
The course details will include:
Note: Course outline is subject to change without notice. Please check back regularly for updates.
Wholesalers, Distributors, Importers, Manufacturers, Quality Assurance Directors and Managers, Operations Managers who have direct responsibility for Quality Management; Quality Unit, Regulatory Affairs, Consultants, Auditors.