Maybe you need a Cleanroom? Let’s check with Philippe Bourbon
The use of a cleanroom is something that depends on your products. Philippe Bourbon from the laboratory Icare will explain to us what exactly is needed to install and maintain cleanrooms. The post Maybe you need a Cleanroom? Let’s check with Philippe Bourbon appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Medical Device made Easy Podcast
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Show Notes
Cleanroom is an equipement that a lot of Medical Device manufacturer need to have. But do you really need it? How much does it cost? How to qualify it? How to maintain it? Philippe Bourbon from Groupe Icare Laboratory will help us understand all that. Check also the summary provided as a download.
Who is Philippe Bourbon?
Physician, passionate about topics related to particulate, microbiological and chemical contamination on industrial sites and health sectors. 30 years of experience, knowledge in a Cofrac and cGMP / BPF environment, Consulting / Training, Expert in contamination control, and sterilization processes, Sales, Technical Developments, Management of technicians, managers and salespeople , Activity Manager. Expertises: Sterilization by heat, S.I.P., Ethylene oxide, depyrogenation, cleanrooms and controlled environment, microbiological and chemical confinement, climatic and thermostatic chambers, compressed gas Pharmaceutical Regulation (GMP / cGMP), Medical Devices, Standards (ISO14644, ISO17665, FDX15-140, …) Diagnosis / Consulting / Validation strategy / Qualifications / Audits / Trouble shooting
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and notably Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now made the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses…
Links
- Philippe Bourbon Linkedin: https://www.linkedin.com/in/philippe-bourbon-a3227818/
- Groupe Icare website: https://www.groupeicare.com/en/home/
- Download cheat sheet: https://mailchi.mp/easymedicaldevice/190
- eQMS Scube SmartEye: https://scube-technologies.com/
Social Media to follow
- Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
- Twitter: https://twitter.com/elazzouzim
- Pinterest: https://www.pinterest.com/easymedicaldevice
- Instagram: https://www.instagram.com/easymedicaldevice
The post Maybe you need a Cleanroom? Let’s check with Philippe Bourbon appeared first on Medical Device made Easy Podcast. Monir El Azzouzi