After a successful first webinar the CQV Benelux organizes it’s second webinar. Learn about the Contamination Control Strategy (CCS) from Holistic view to relevant details. Even an interesting story about the focus on cleaning frequency’s, gowning and environmental monitoring during production/in process.
Speakers:
Attending the webinar is free for ISPE members. Non-members have to pay a fee of only €10,-. Registration is required.
Special thanks to our sponsors:
Event Date | 08-Nov-2022 15.00 |
Capacity | 100 |
Registered | 49 |
Individual Price | €10.00 |
15:00 |
Welcome |
15:05 |
CQV Chairman Tim Vertongen: IntroductionA warm welcome by our chairman for the speakers and introducing them and our subject of the day: Contamination Control Strategy (CCS) |
15:20 |
Frans Saurwalt; Contamination Control Strategy: From Holistic view to relevant detailsFrans Saurwalt, (Technical Manager at Kropman Contamination Control) Annex 1: “2.3…A Contamination Control Strategy (CCS) should be implemented across the facility in order to define all critical control points and assess the effectiveness of all the controls……. and monitoring measures employed to manage risks to medicinal product quality and safety...” “2.5 The development of the CCS requires detailed technical and process knowledge…………” This presentation will address ways to approach this in a practical way. |
15:50 |
Vanessa Morini; Contamination Control in practiceVanessa Morini (CEO & Co-founder Tru cleanroom cleaning) Her presentation will be about Cleaning Frequency's, Environmental monitoring and gowning during production |
16:20 |
Q&A |
17:00 |
Closure |
Vanessa is Entrepreneur since 2019 with co-founding Tru Cleanroom Cleaning. Before this she is well respected and active for more then 15 years in the life -science industry for companies as J&J and Sanofi.
Frans has 35+ years of experience in design, construction, commissioning, testing, documenting and qualification of contamination control projects. This includes GMP, Biosafety, Medical devices, Health care, Radiopharmaceutical and Micro-electronics facilities Frans is active in ISO, CEN and Dutch standards and guidelines as well as in the CC community (VCCN, ISPE, ICCCS, EHEDG)