Wednesday, August 17, 2022

What is Pharmaceutical Temperature Mapping?

GMP Compliant and Temperature Mapping Workshop


Greetings!


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.



Who Should Attend?


Wholesalers, Distributors, Importers, Manufacturers, Quality Assurance Directors and Managers, Operations Managers who have direct responsibility for Quality Management, Quality Unit, Regulatory Affairs, Consultants, Auditors.

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Course Outline


This webinar will cover the different best practices you have to implement, whether you ship or store temperature-sensitive products. Participants will learn about the regulator context, what has to be done and how with concrete real examples and case studies.


The course details will include:

  • Temperature Mapping Introduction
  • Why should you comply?
  • What is a Quality Product?
  • How do we achieve Compliance?
  • Environmental Controls
  • Application of Controls
  • Selection of data loggers
  • When should temperature mapping be completed?
  • Audit and Risk Assessment
  • Temperature Mapping Protocol
  • Methodology
  • Review and Data Analysis
  • Summary Report
  • Impact of not completing Temperature Mapping
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Date and Time:

August 25, 2022

1:00 PM - 4:00 PM (EST)


How is the webinar delivered?

Live, interactive, instructor-led

GET CERTIFIED TODAY!

Interested in this workshop?

Register today by calling our team at 416-502-2277 or email us at info@aaps.ca.

Academy of Applied Pharmaceutical Sciences

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