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Quality risk management for cleanroom garment qualification in the light of GMP Annex 1

Webinar

Monday, 23rd March,2020 
11:00 to 12.00 CET

Replay

Helping you to understand key QRM principles for cleanroom garments

According to current GMP guidelines all aseptic manufacturing of sterile products should be managed by applying Quality Risk Management principles, that provide a proactive means of identifying, scientifically evaluating and controlling potential risks to quality. Because many factors contribute to the overall quality and suitability of cleanroom garment systems, the cleanroom garment qualification process is very important. During the webinar you will have the unique chance to learn about QRM principles for cleanroom garments, understand contamination risks as well as validation processes, all in the light of the latest draft of GMP Annex 1.

Presented by:

Steve Marnach

EMEA Training Manager and Critical Environments Expert
Steve joined DuPont in 1995 and has a Masters’ degree in Business Administration. After having held various positions within the company, he is currently the EMEA Training Manager and Critical Environments Marketing Specialist for DuPont Personal Protection, the chemical protective garments business that Steve has been working for since 2003. In his current role, Steve provides training sessions on the selection and safe handling of chemical protective garments used in, amongst others, pharmaceutical production and GMP grade B, C and D cleanroom operations, as well as giving technical support to all customers.