HVAC: Practical Guidance for GMP Facilities

Good operational practices may be the key to good cGMP operations. A poor facility design can weaken even the best operations. In this webinar, learn key hallmarks of good heating, ventilation, and air conditioning (HVAC) design and the tell-tale signs of underlying problems. Primary objectives are familiarizing participants with the contents of the ISPE Good Practice Guide: Heating, Ventilation, and Air Conditioning (set for release in September 2009), and advising on application of the Guide’s best practices. At the conclusion of this session, participants will be able to:

  • Understand basic HVAC terms and equipment
  • Know critical issues faced by HVAC designers
  • Understand the relationship between product potency versus cross-contamination and resultant facility design features
  • Review typical designs for HVAC by facility type
  • Gain an understanding of basic cleanroom theory including: types of cleanrooms and flows; affect of people on room cleanliness; and relationship between filter rating versus mass and particle count efficiency
  • Know the pros and cons of energy saving practices
  • Be aware of common installation/startup issues with HVAC equipment
  • Have insight into the practical application of risk assessment for HVAC; tell-tale signs of inadequate risk assessment, and in which facilities and processes HVAC typically tends to be higher and lower risk
Norman A. Goldschmidt
Genesis Engineers Inc

Norman Goldschmidt is Vice President and Principal at Genesis Engineers, a full service A&E / EPCM firm based in Philadelphia. He has nearly 25 years of experience in planning, design and construction in the pharmaceutical and biotech industry. Prior to joining Genesis, Norman served in numerous capacities during 20 years with Bristol-Myers Squibb (BMS). Starting as a Mechanical Engineer / Project Manager and culminating as Executive Director, Global Engineering for Strategy and Design. His industry experience spans the many types of facilities and processes necessary to bring a drug to market - from R&D through Manufacturing. Goldschmidt studied Engineering Management at the State University of New York and Mechanical Engineering at the University of Buffalo. He holds four patents for innovations in HVAC and Pharmaceutical Processing, is an International Standards Organization (ISO) delegate, Adjunct Professor at the New Jersey Institute of Technology. Goldschmidt, a member of ISPE and the New Jersey Chapter sin 1996 was the lead author of the ISPE Good Practice Guide for HVAC as well as author, contributor and instructor for ISPE, ASHRAE, NSF and others.

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