Maintaining Temperature Compliance for Pharmaceuticals in the Supply Chain

A Continuing Education opportunity for the Responsible Person and the WDA holder


Course description

This webinar follows the success of the SeerPharma(UK) Responsible Person Continuing Education programme. The majority of medicines must be stored and transported within a specified range. Maintaining the correct temperatures at all stages throughout the supply chain is a difficulty faced at all stages but is a key feature of Good Distribution Practice (GDP). Decisions must be made to address temperature excursions. These decisions affect the quality of the medicine received by the user but are also regularly noted by regulatory inspectors as a non-compliance. As a former MHRA inspector with current and relevant hands-on distribution knowledge, Madeleine knows the difficulties you face and can help you protect the user, avoid expensive mistakes and keep on the right side of the regulator.

This Webinar takes you through preventative measures and a decision making process to address those temperature excursions. Frequently seen good and bad practices are used to illustrate the difficulties. There will be plenty of opportunities to interact and opportunities to assess your knowledge and your company procedures.

Course content

  • Equipment selection
  • Qualification of equipment
  • Validation of processes
  • Managing temperature excursions
  • The use of stability data
  • The use of Mean Kinetic Temperature (MKT)

Who should attend

This webinar is intended for the Responsible Person named on the WDA, the holder of the WDA, third party storage and transport providers, and Quality Assurance professionals.