New EU-GMP-Annex 1 and upcoming requirements for Clean Rooms, disinfectants, GMP-gas-systems, and GMP-water-systems.
With the issuing of the 2nd draft version of the new EU-GMP-Annex 1, we are all called to do a gap analysis “old vs new”.
Eurofins BPT will host a webinar addressing the current concerns, requirements, guidelines and optimized approach to secure full compliance in terms of these new upcoming GMP requirements. This webinar aims at providing overall vision in regard to gaps for clean rooms, disinfectants, GMP-gas-systems, and GMP-water-systems.
During the webinar we will be discussing strategies for securing compliance both at PQ stage and monitoring.
An important part of the program will focus on the best practices for sampling and testing.
The main topics for the webinar:
- Clean rooms and controlled environments: new requirements for state of control and qualification / re-qualification.
- Disinfectants and disinfection: new requirements in regard to how to demonstrate efficacy of disinfection processes and disinfectants in general.
- GMP-Gas-systems: deep dive in regard to requirements for gases in direct contact with product/primary container surfaces.
- GMP-Water-systems: advances on monitoring and qualification considering novel process analytical technologies.
Who will benefit from attending the webinar?
The GMP compliance for clean rooms, disinfectants, GMP-gas-systems, and GMP-water-systems can have shared responsibilities between multiple functions within an organization, including (but not limited to):
-Critical Utility Manager / department
-Utilities Responsible
-Quality Manager / department
-Quality Control Manager / department
-Outsourcing Managers
-Production Manager
-Process analysts
-Quality auditors
-Process support
When:
19th November 2020, 10.00 – 12.30
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Webinar program: New EU-GMP-Annex 1 and upcoming requirements for Clean Rooms, disinfectants, GMP-gas-systems, and GMP-water-systems. |
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10.30 – 10.45 |
Introduction about Eurofins BioPharma Product Testing Denmark A/S
Speaker: Edris Sadat, Business Development Manager, Medical Device |
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10.45 – 11.05 |
What´s new for Clean rooms and controlled environments? Speaker: Pablo Moreno, Process Control and Validation Manager
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11.05 – 11.20 |
What´s new on disinfection? Speaker: Pablo Moreno, Process Control and Validation Manager
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11.20 – 11.40 |
What´s new for GMP gas systems? Speaker: Pablo Moreno, Process Control and Validation Manager
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11.40 – 12.00 |
What´s new for GMP water systems? Speaker: Pablo Moreno, Process Control and Validation Manager
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12.00 – 12.25 |
Time for questions |
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12.25 – 12.30 |
Closure |
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Eurofins will provide Material & Attendance Certificate |
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Speakers
Mr. Pablo Moreno, M.Sc.Eng. acts as Business Unit Manager for Process Control and Validation at Eurofins Biopharma Product Testing in Denmark since 2016. Prior to his employment at Eurofins BPT, Mr. Pablo Moreno worked 11 years as a Business Unit Manager for Process Control and Validation in Italy, with a staff of 12 employees. His in-depth knowledge and problem solving mindset, makes Mr. Pablo Moreno a highly qualified expert in analytical testing, trending and qualification/validation services for a wide range of critical utilities like gasses, water systems and HVACs. Since 2013 Pablo has been an active member of ISPE.