Recorded Webinar – GMP Compliant Temperature Mapping

Recorded Webinar Time: 1.5 Hours Cost: CAD$600+HST Buy Now!

Distinguished Faculty

Ms. Deborah Gordon B. Sc

Instructor and Program Chair
AAPS

Deborah Gordon, B. Sc., Dip. Pharm. QA, began her career in the Sciences as a Forensic Analyst working on crime scenes and in the lab, analyzing evidence to be presented in court. Her attention to detail, which was critical to crime scene investigation, eventually led her to the Quality Assurance field. Her experience as a Forensic Analyst paved the way for her career growth. In 2008, Deborah completed her training as an Auditor by successfully passing the American Society for Quality Auditor examination, (ASQ, CQA).

Deborah has 16 years of experience in the pharmaceutical industry, including 15 years of auditing experience. Her experience includes Quality Systems for storage, distribution, wholesaling, packaging/labeling and manufacturing of pharmaceuticals. She has done extensive work in temperature mapping of warehouses, fridges and freezers. As a leader in pharmaceutical quality assurance, she also enjoys the challenge of auditing and teaching.

Abstract

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, for example every three years 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.

Topics to be covered

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:

  • 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

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.