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
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At http://www.webex.com/test-meeting.html
you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plugin. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
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