How to control gas systems under GMP
Free Seminar
Date: Friday 1st February 2019
Time: 13.00 – 15.30
Address: Eurofins Professional Scientific Services Denmark A/S, Ørnebjergvej 1, 2600 Glostrup, Denmark
How to control gas systems under GMP?
There is an increasing focus from the regulatory authorities and a general concern in the biopharma industry regarding the monitoring and analysis of critical gasses which falls under GMP requirements i.e. all gasses which are in direct contact with the final product in a GMP production. Eurofins BPT will host a Mini-Seminar addressing the current concerns, requirements, guidelines and optimized approach to secure full compliance both in terms of GMP testing of both “purity” and “impurities”.
The main topics for the Seminar:
- Guidelines for when GMP testing is required?
- Typical frequencies for testing. Benchmarking against what others are doing.
- Sampling point determination i.e. which are critical and why?
- Testing parameters, securing compliance and state of control in an optimized way.
- What does it mean to qualify the gas-reservoirs/supply? And what does it mean to qualify the gas-distribution-line?
Who will benefit from attending the Seminar?
Gas testing under GMP can be a shared responsibility between multiple functions in an organization, including (not limited to):
- Critical Utility Manager / department
- Utilities Responsible
- Quality Manager / department
- Quality Control Manager / department
- Outsourcing Managers
- Production Manager
- Process support
- Process analysts
- Quality auditors
- Research and Development
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Agenda |
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13.00 – 13.15 |
Registration and networking Snack & Coffee |
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13.15 – 15.15 |
How to control gas systems under GMP? Speaker: Pablo Moreno, Process Control and Validation Manager |
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15.15 – 15.30 |
Questions from the audience |
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Eurofins will provide Material & an 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.