• Implement global GMPs for HVAC and Environmental Control
• Control and monitor HVAC system-critical parameters 
• Utilize pharmaceutical cleanroom air classifications 
• Improve product protection through efficient HVAC operation 
• Select HVAC system designs appropriate for each production phase

• GMPs for Environmental Control and HVAC
• Control of Contaminants and Cross-Contamination in Critical Environments
• The Design to Qualification Process (The Design Continuum)
• Cleanroom Design Considerations
• Cleanroom Design Techniques
• Typical Systems
• Documentation, Maintenance and Inspection
• Other References
• Final Exam, Exercises

• Pre-Course work materials
• Interactive hands-on exercises
• Tour of an HVAC system for various cleanroom grades from Grade D to Grade B at the EASE facility
• ISPE Good Practice Guide: Heating, Ventilation, and Air Conditioning

Stephan Neumann

Global Governance Critical Utilities

Boehringer Ingelheim GmbH

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.

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

• System and component sanitisation procedures and microbial control 
• Guidance regarding appropriate monitoring programmes during ongoing operation as well as during initial system qualification.

• Regulatory
• Planning and Programming
• Basic Water Chemistry and Microbiology
• Pretreatment and Purification Processes
• Choice of Systems and Processes
• Basic Chemistry and Microbiology
• Storage and Distribution Configurations
• Storage and Distribution Design
• Rogue, Stainless Steel and Passivation
• Tradition, Risk and Science Based Water System
• System Sampling

• Pre-Course work materials
  • This course includes access to course content that provides a review of the basics prior to the classroom course. Access information will be provided via email one week prior to the start of the training event.
  • The course will also cover regulatory requirements including USP, EP, and JP Monographs, the USFDA Guide to Inspections of High Purity Water Systems, current FDA views, and current Good Manufacturing Practice (cGMP) requirements. Common water system myths will also be explored and a variety of practical system designs will be evaluated for EP, EMA, USP and FDA compliance, as well as their advantages and disadvantages. Particular attention will be paid to system and component sanitization procedures and microbial control.
• Interactive exercises
• Utilities Tour of a HPW/WFI system + Pure Steam generator at the EASE facility
• Learning assessments
• Baseline Guide Vol 4: Water & Steam Systems 3rd Edition
• Good Practice Guide: Sampling for Pharmaceutical Water, Steam, and Process Gases

Stephan Neumann

Global Governance Critical Utilities

Boehringer Ingelheim GmbH

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.