Stand Out in Your Field with Specialized Training
Ensure control of critical environments within your facility and maintain GMP inspection readiness through improvements to your air, HVAC, and contamination controls. Topics include control system alarm management, common system construction deficiencies, GMP documentation, maintaining an "inspection ready" state, frequency of testing and balancing, airflow visualization, air change rate reduction and more.
Stephan Neumann an M.Sc. in Utility Engineering and an M.Sc. in Pharmaceutical Microbiology. With a tenure at Boehringer Ingelheim since 2002, he has held various roles in local engineering and Corporate Quality and currently serving as the Global Head of HVAV & Critical Utilities in the global engineering organization. His experiences include designing, commissioning, and validating HVAC and Critical Utilities systems, as well as providing support and maintaining technical engineering standards for pharmaceutical water systems and HVAC systems across the global production sites.
He did contribute to the ISPE Handbook "Production of Water for Injection without Distillation", which describes multiple ways to produce WFI acc. to European regulations. He also was a chapter lead for the ISPE Good Practice Guide on "Membrane Based WFI systems", ISPE Good Practice Guide on "Maintenance" and was co-chairing the revision of the ISPE Good Practice Guide on "Process Gases".
Stephan is also one of two technical experts of the EDQM Water Group. This group is responsible for the water monographies in the European Union.
Training course times are listed in Central European Time (CET). Find your personal viewing time on the World Clock.
0830 – 0845 | Login |
0845 - 0900 | Introductions |
0900 - 1030 | Course Content & Exercise |
1030 - 1045 | Break |
1045 - 1215 | Course Content & Exercise |
1215 - 1300 | Lunch |
1300 - 1430 | Course Content & Exercise |
1430 - 1445 | Break |
1445 - 1615 | Course Content & Exercise |
1615 - 1630 | Wrap-up, Questions, Discussion |
0830 – 0845 | Login |
0845 - 0900 | Recap |
0900 - 1030 | Course Content & Exercise |
1030 - 1045 | Break |
1045 - 1215 | Course Content & Exercise |
1215 - 1300 | Lunch |
1300 - 1430 | Course Content & Exercise |
1430 - 1445 | Break |
1445 - 1615 | Course Content & Exercise |
1615 - 1630 | Wrap-up, Questions, Discussion |
Pharmaceutical Water is, perhaps, the most important of all pharmaceutical utilities. It is used as an excipient in many pharmaceutical formulations, as a cleaning agent, and as a separately packaged product diluent. In addition to non-compendial systems, pharmaceutical facilities typically include systems for delivering pharmacopoeial Purified Water (PW) Water for Injections (WFI), and Highly Purified Water (HPW).
This course has been substantially updated to feature the guiding principles of the ISPE Baseline Guide: Water and Steam Systems (Second Edition) with particular emphasis placed upon microbial control and laboratory water as well as key design philosophies. The principles of design and operation of water systems used directly in pharmaceutical manufacturing and laboratory applications, including the essential concepts and principles of systems used to generate USP, EP and non-compendial waters will be covered. These concepts include specification, design, operation, testing, and maintenance of equipment and systems for water generation.
Upon completing days 1 and 2 of this event, you will be able to examine methods for proper water quality selection and receive detailed guidance regarding the choice and use of appropriate construction materials and instrumentation. Particular attention will be paid to
Stephan Neumann an M.Sc. in Utility Engineering and an M.Sc. in Pharmaceutical Microbiology. With a tenure at Boehringer Ingelheim since 2002, he has held various roles in local engineering and Corporate Quality and currently serving as the Global Head of HVAV & Critical Utilities in the global engineering organization. His experiences include designing, commissioning, and validating HVAC and Critical Utilities systems, as well as providing support and maintaining technical engineering standards for pharmaceutical water systems and HVAC systems across the global production sites.
He did contribute to the ISPE Handbook "Production of Water for Injection without Distillation", which describes multiple ways to produce WFI acc. to European regulations. He also was a chapter lead for the ISPE Good Practice Guide on "Membrane Based WFI systems", ISPE Good Practice Guide on "Maintenance" and was co-chairing the revision of the ISPE Good Practice Guide on "Process Gases".
Stephan is also one of two technical experts of the EDQM Water Group. This group is responsible for the water monographies in the European Union.
Training course times are listed in Central European Time (CET). Find your personal viewing time on the World Clock.
0830 – 0845 | Login |
0845 - 0900 | Introductions |
0900 - 1030 | Course Content & Exercise |
1030 - 1045 | Break |
1045 - 1215 | Course Content & Exercise |
1215 - 1300 | Lunch |
1300 - 1430 | Course Content & Exercise |
1430 - 1445 | Break |
1445 - 1615 | Course Content & Exercise |
1615 - 1630 | Wrap-up, Questions, Discussion |
0830 – 0845 | Login |
0845 - 0900 | Recap |
0900 - 1030 | Course Content & Exercise |
1030 - 1045 | Break |
1045 - 1215 | Course Content & Exercise |
1215 - 1300 | Lunch |
1300 - 1430 | Course Content & Exercise |
1430 - 1445 | Break |
1445 - 1615 | Course Content & Exercise |
1615 - 1630 | Wrap-up, Questions, Discussion |
Early Registration *Ends 13 Feb 2024 | Regular Registration | |
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Member | $3,200.00 | $3,500.00 |
Non Member | $3,500.00 | $3,800.00 |
Government | $1,600.00 | $1,600.00 |
Student | $1,000.00 | $1,000.00 |