News GMP for engineering department training course
27-28 September 2018
Kiev
Course Objectives
This training explained how the requirements laid down in the GMP and FDA regulations can be put into engineering practice. The whole lifecycle from the design, the qualification and the maintenance of utilities was covered.
Target audience
- specialists of maintains, engineering, production and quality assurance departments.
What you will receive by participating in the seminar:
- to obtain practical skills for risk analysis;
- improve their knowledge of Good engineering practice;
- will gain knowledge on the future of ways to meet the requirements of GMP in the design, installation, qualification, and operation: clean rooms, systems for obtaining and distributing purified water, water for injection, pure steam and compressed air
Agenda
27.09.2018 |
|
09:30 – 11:00 |
Quality risk assessment for the design |
11:15 – 13:00 |
Production, storage, and distribution of purified water and water for injection: - requirements - production, - storage and distribution, - qualification and re-qualification of systems based on risk managment, - monitoring, - inspection practice based on risk analysis. |
13:00 – 14:00 |
Lunch break |
14:00 –16:15 |
Production and distribution of pure steam, compressed air, nitrogen: - requirements - production, - distribution, - qualification and re-qualification of systems based on risk managment, - monitoring, - inspection practice based on risk assessment. |
16:30 -17:30 |
Case study |
28.09.2018 |
|
09:00 – 13:00 |
Clean rooms and HVAC system: - requirements, - AHU, - design based on risk analysis, - prevention of cross-contamination, - selection of the optimal air pressure differences between the rooms, - optimization of operating costs for ventilation in the framework of GMP requirements, - clean rooms garments, - qualification and re-qualification based on the risk assessment, - monitoring, - inspection practice. |
13:00 – 14:00 |
Lunch break |
14:00 –16:15 |
RABS & isolator: - classification, - principles of the HVAC, - material flows, - integration with equipment, - qualification. |
16:30 -17:00 |
Case study |
17:00 –17:30 |
Testing and discussion of results |
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