Temperature qualification has long been a requirement for areas used for the storage of pharmaceutical products and the maturing regulatory requirements have increasingly higher expectations for compliance in this area. The EU-GDP Guidelines (Chapter 3 – Premises and Equipment) provide some broad requirements but with little guidance on the ‘how to’ element, and the WHO guidelines (Supplement 8 –Temperature mapping of storage areas) goes a step further in regards to technical elements.
This webinar is aimed at taking out the guess work of such an exercise and clearly outlining the main components of a successful and compliant qualification.
This webinar is designed for all managers, supervisors, technical staff, Responsible Persons (RP’s) and other employees who are involved in the compliant storage of temperature sensitive pharmaceutical products within a GxP environment. It will be of interest in particular for personnel from the following departments:
- Quality Assurance
- Cold Chain
- Regulatory Compliance
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
The aim of this webinar is to provide attendees an overview of the qualification process and its implementation. The following topics will be covered:
- The regulatory landscape in regards to temperature qualification
- The approach to facility qualification using the IQ/OQ/PQ cycle
- How to prepare for the thermal qualification of cold storage and warehousing facilities
- How the process differs with new or existing facilities
- Corrective actions and recommendations for permanent monitoring
Date of the recording: 30.11.2020
Duration of the recording: approx. 1.5 h