logo
logo
Loading Events

« All Events

  • This event has passed.

GMP Compliant and Temperature Mapping Workshop

January 11, 2021 @ 8:00 am - 5:00 pm

GMP Compliant and Temperature Mapping Workshop

Live interactive and instructor led

Abstract

All pharmaceutical products are temperature sensitive. 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 labeled storage conditions. Whether they are ambient, refrigerated, frozen, on dry ice, or liquid nitrogen, it is crucial to take action to avoid cold chain failure that could impact the integrity of your products. Inside a tank, a freezer, a fridge, an incubator, a room, a warehouse, a trailer, or a shipping box, there are some best practices you have to follow to meet regulatory requirements.

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.

Topics to be covered

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:

  • Definition
  • 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
  • Final Advice

Note: Course outline is subject to change without notice. Please check back regularly for updates.

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.

Certificate of Attendance and Course Material

  • All participants will receive a certificate of attendance upon completion of the course.
  • The participants will be receiving specially prepared course manual.

Details

Date:
January 11, 2021
Time:
8:00 am - 5:00 pm