The accreditors of this session require that you periodically check in to verify that you are still attentive.
Please click the button below to indicate that you are.
Over the last decade, CGT Catapult has worked with industry in the development, production and adoption of ATMPs. CGT Catapult is an independent innovation and technology organization committed to the advancement of cell and gene therapies, with a vision for a thriving industry delivering life-changing advanced therapies to the world. PM Group designed the Catapult facility and will describe a process they have developed to accommodate multiple modalities within the same facility that is starting to be used more widely within the industry. CGT Catapult will then explain how they have been able to remain compliant having received multiple GXP inspections for a range of different ATMP modalities.
The new EudraLex Annex 1 describes very prescisly the requirements how to transfer any material from lower grades to the Grade A area with a special focus on Contamination Control…
FAMAR as a dynamically developing CDMO, actively operates in an extremely demanding legislative framework for the successful development, sustainable production and timely availability of pharmaceutical products fully compliant with the established regulations & specifications…