This course is a part of our advanced level Master Class series. Seats are limited.
The application of Heating, Ventilation and Air Conditioning (HVAC) systems to achieve controlled operating environments is among the most important engineering and compliance issues to be addressed by the pharmaceutical industry. In order to apply environmental controls efficiently and effectively, it is necessary to understand the principals of HVAC design, control, and monitoring. This course is designed to explore beneath the surface of environmental conditions into the why and how of HVAC system and controlled environment design and application.
This interactive full day lecture will provide comprehensive coverage of HVAC Systems, clean rooms and other controlled environments. It will draw extensively upon ISO Standard 14644 Clean Rooms and Associated Controlled Environments as well as other industry standards.
It will explore:
- – Environmental requirements
- – Types and classification of controlled environments
- – Sources of contamination
- – Risk evaluation
- – Design parameters and options
- – Design and operating myths, control systems
- – System commissioning and qualification
- – Operating requirements (including access control and gowning)
- – Environmental monitoring
- – Risk management
- – Deviations
This course is intended for individuals with a basic understanding and experience with controlled spaces for the manufacturing, testing and holding of pharmaceutical and biological products. It will present a balance of engineering and compliance content so that it will be valuable for those who are required to specify, design and maintain HVAC systems, as well as those who use them and oversee their performance (e.g., Quality Assurance, Regulatory Investigators).
SPEAKER: Mr. Phil DeSantis
Phil DeSantis is a pharmaceutical consultant, specializing in Pharmaceutical Engineering and Compliance. Phil retired in 2011 as Senior Director, Pharmaceutical Engineering Compliance for Global Engineering Service at Merck (formerly Schering-Plough) located in Whitehouse Station, NJ. His responsibilities included development, implementation and support of standards and practices for all facility and equipment-related capital projects and site operations. He served as Global Subject Matter Expert for Facilities and Equipment and on the Global Validation Review Board and Quality Systems and Standards Committee.
Phil is a chemical engineer, having received a BSChE from the University of Pennsylvania and an MSChE from New Jersey Institute of Technology. He has over forty-four years of pharmaceutical engineering industry experience. Prior to Schering-Plough, Phil held executive positions for Fluor Corporation and Raytheon Engineers & Constructors, where he led groups providing validation and compliance consulting services to pharmaceutical and biotech clients. Prior to that, he served in technical positions in several major pharmaceutical firms, including Squibb, Ortho Pharmaceutical Corporation and an earlier period at Merck. He is on the PDA Scientific Advisory Board and is active in the International Society for Pharmaceutical Engineering (ISPE). He has been as a frequent lecturer for both organizations. He has published or contributed to several articles and books in the area of validation and pharmaceutical engineering. In addition, Phil has lectured on “Steam and Dry Heat Sterilization” as part of the FDA’s field investigator training program.
Phil’s background includes pioneering work in the genesis and evolution of process validation. His work in this area has led to broad expertise in all aspects of pharmaceutical manufacturing that support and ensure reliable and effective processes. Currently, Phil’s primary focus areas of GMP Services include: facilities & equipment, quality systems, project management, and professional development.
|Basic Member Ticket:||$795.00||— Sold Out|
|Pro/Pro Plus Member Ticket:||$745.00||— Sold Out|