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Heating, Ventilation & A/C in a Regulated Environment

  January 24, 2018  
CfPIE - The Center for Professional Innovation & Education, Malvern, PA USA
December 5 - 7, 2018

Course Description: Course runs 9 a.m. 5 p.m. on Day 1 & Day 2; 9 a.m. – 3 p.m. on Day 3 (Breakfast & Lunch Included)

This is a three-day course designed to provide individuals with an in-depth understanding of how the HVAC system works including: design, balancing, commissioning, operation and maintenance in regulated environments, hospitals, and medical facilities. The course consists of lectures, HVAC system basics and imbedded exercises.

Participants will also be placed in several real life HVAC system testing 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.

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 program will provide you with the training needed to enhance your understanding of how the HVAC system works 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.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


Organized by: Center for Professional Innovation & Education
Invited Speakers:

Richard F. Newmiller

Specialties: Manufacturing, Regulatory

Richard F. Newmiller has over 20 years of Pharmaceutical Industry experience.  Presently he is a Management Consultant supplying Engineering and project management services with a unique background that includes corporate, contractor, designer and owner perspective.

He has provided Engineering, consulting, operations, and maintenance expertise as an employee for a variety of manufacturing and research organizations including Merck, SmithKline Beckman   (now Glaxo SmithKline), Centocor (now Johnson & Johnson) and Wyeth (now Pfizer) where he was Senior Director of Project Engineering in Global Engineering Services.

Richard is also consulting in the regulated medical marijuana industry providing guidance and direction in the areas of scope definition, compliance, operating environment, design and engineering management, budget and schedule development, and commissioning.

Richard has executed hundreds of Pharma projects with a value in excess of $2 billion. Responsibilities included obtaining funding, contractor selection, design, engineering, start-up, commissioning, validation and assisting with establishment and product licensing. Those projects produced products that ranged from topicals, liquids, and solid dosage to injectables supporting OTC, diagnostic, biological, and pharmaceutical operations in the US, Canada, Puerto Rico, England and Holland. Rich received his B.S. in Mechanical Engineering from Drexel University, and an MBA from Temple University; he earned his Professional Engineering (PE) license in Pennsylvania.

Other Courses:

Deadline for Abstracts: N/A
Registration: https://www.cfpie.com/ProductDetails.aspx?ProductID=237
E-mail: info@cfpie.com
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