Heating, Ventilation, & Air Conditioning (HVAC) in a Regulated E

Course Description - Course runs 9:00 - 5:00 on Day 1 & Day 2 -- 9:00 - 3:00 on Day 3 (Breakfast & Lunch Included)

This is a three-day course designed to provide individuals with an in depth understanding of the design, balancing, commissioning, operation and maintenance of HVAC systems in a regulated environment. The course consists of lectures and imbedded exercises. Participants will also be placed in several real life situations such as completing a compliance review of floor plans and air flow diagrams, room pressurization schemes, ductwork design, and air balance reports; conducting emergency egress analysis during a system failure; HVAC risk assessment; and change control analysis including the impact of modifications requested by the end user.

The course is designed to provide the attendee with thorough knowledge of the following topics:

The governing regulatory agencies with direct impact on HVAC systems
FDA and EU classified space comparison
What constitutes Good Engineering Practice
The major components of an HVAC system
A high level overview of Psychrometrics
The engineering and design process
Latent and sensible loads
Types of systems – application and operation
Energy conservation measures and their impact on system performance
Ventilation requirements
Control set points and alarms
Air balancing – cascading air flows and room pressurization
Risk assessment for HVAC
Air filtration – from bird screens to terminal HEPA filters
Sources of air particle contamination
Room air-change rates – ISO standards
Room recovery period versus air change rates
Sterility versus containment
Humidity and temperature set points – range of control and tolerances
Instrument calibration – critical, non-critical, and informational
Maintenance impacts to system performance, reliability, and validation
Partnering with the system owner to obtain funding for major repairs, upgrades or wholesale replacement
Personnel safety and egress considerations
The importance of as-built documentation – user and field directed changes
The engineering turnover package (ETOP) and commissioning

Who Should Attend

This course is specifically designed for non-engineers such as Regulatory, Quality, Validation, R&D, Clinical, Manufacturing, Maintenance and Management personnel who are functioning as inspectors, auditors, investigators, operators, and end-users as well as those in project team or project management roles.

This three-day program will provide you with the training needed to enhance your understanding of HVAC systems in terms of design, construction, commissioning and maintenance to ensure compliance with Good Engineering Practice, International Standards Organization (ISO) criteria, Food and Drug Administration (FDA) Regulations and Guidance, European Union (EU) Directives, European Drug Regulating Authorities Lexicon (EudraLex) Guides, and International Conference on Harmonization (ICH) Guidelines.