Pharma / BiotechMedical Device
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:
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.
Introductions & Agenda Review 9:00am – 9:30am
Major Components of HVAC Systems 9:30am – 10:30am
Governing Regulatory Agencies 10:45am – 12:30pm
Lunch 12:30pm – 1:30pm
Good Engineering Practice 1:30pm – 2:30pm
Project Management 2:30pm – 3:30pm
Psychrometric Overview 3:45pm – 4:30pm
Recap, Questions and Answers 4:30pm - 5:00pm
Air Filtration 9:00am – 10:30am
ISO Standards and Others 10:45am – 11:30am
Types of Systems 11:30am – 12:30pm
Air Balancing 1:30pm – 2:45pm
Commissioning and Validation 2:45pm – 3:30pm
Safety Consideration 3:45pm – 4:30pm
Recap, Questions and Answers 4:30pm – 5:00pm
Risk Assessment 9:00am – 9:30am
Monitoring System Performance 9:30am – 10:30am
Instrumentation Calibration 10:45pm - 12:30pm
Maintenance Operations 1:30pm – 2:30pm
Obtaining Funds for Repairs, Replacement, or Upgrades 2:30pm – 3:30pm
Recap, Questions and Answers 3:45pm – 4:15pm
Course Evaluation 4:15pm – 4:30pm
Upon completion of this course, each participant will have a comprehensive overview and understanding of HVAC systems and how they are designed, installed, commissioned, and maintained in a regulated environment. The course content will enable the participant to understand the system design, ask more informed questions, and challenge the findings when communicating in a group setting on a broad variety of HVAC issues. In addition, the regulatory agencies with a direct impact on the design and operation of classified and non-classified environments will be presented.
"The Course Director was extremely knowledgeable with HVAC in any and all aspects. Overall a great course and definitely learned a lot." Mike K., Manager Quality Assurance – Dr. Reddy's Labs
"First off, the course director was excellent! Extremely knowledgeable, conveyed topics clearly and concisely, and most of all had a great sense of humor. I really enjoyed attending." Mike A., Manufacturing Engineer, Sanovas
"Good presentation, engagement of group, clear delivery. Sufficient time for presentation of materials. Helped my understanding of HVAC." Lindani M., Internal Auditor – Mead Johnson Nutrition
"This course was exactly what I needed during the process of designing our facility. The Course Director is very knowledgeable and has a lot of experience, he was able to answer all of my questions." Andrew R., President, Cannahort Agricultures
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*Valid up to 30 days prior to course date(s). Cannot be combined with other discounts or offers.
The Center for Professional Innovation and Education (CfPIE) provides technical training for Pharmaceutical, Biotech, Medical Device and Skin/Cosmetics professionals. CfPIE offers more than 350 class sessions annually across 80 course titles in multiple formats, such as classroom, on-site and certification programs.
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