Why participate?
Identify the regulatory changes concerning sterile filtration following the implementation of the new Annex 1 of the GMP guidelines.
Ultimately, ensure compliance with the new regulations and be able to justify your filtration-related decisions.
Training Context:
The new Annex 1 was published on August 25, 2022, and came into force on August 25, 2023. While the revised document expanded from 16 to 59 pages and brings significant clarification, many questions remain — especially concerning sterile filtration, including differential pressure monitoring and the implementation of the Pre-Use Post-Sterilization Integrity Test (PUPSIT).
PUPSIT has been one of the most debated topics due to the complexity of its implementation. The SFQRM discussion group from the BPOG-PDA consortium has published several recommendations outlining the pros, cons, and associated risks.
Interactive teaching, real-life examples, experience sharing
Quality assurance, sterility assurance, regulatory compliance, managers, production supervisors
Prerequisites: knowledge of quality assurance, sterility, and regulatory compliance
Prices: Excluding tax, as the training is not subject to VAT.
In-house training rate: Please contact us.
Registering online or by e-mail is a pre-registration. We will process your request within one week:
Signing the training agreement commits the company or individual to the training course. Cancellation conditions are specified in the training agreement.
When no session date is specified, pre-registration allows us to note your interest in a programme, and we will keep you informed as soon as a new session is organised.
For more information, contact Daphné Brisard: 02 47 36 63 18 or formation@mabdesign.fr
