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| There is no pharmaceutical facility that is not equipped with a controlled HVAC system. Pharmaceutical facilities are provided with filtered air to ensure an environment that is controlled with respect to particle contamination: both viable and non-viable. This course will provide participants with an understanding of the design of such systems, GMP requirements behind the design, qualification and ongoing operation, maintenance and monitoring. |
| Benefits to the Participants |
| At the end of this course, participants will have an excellent understanding of the function and correct functioning of an HVAC system in the pharmaceutical workplace. This unique course offering will allow participants to learn about the engineering and GMP aspects of the system from two leading experts in the field. After participating in this course, maintenance and environmental monitoring of HVAC systems as will be seen as part of a single puzzle that when correctly assembled allows the company to provide a trouble free environment appropriate to the products manufactured within. |
| Issues to be covered |
- The GMP regulations:
- EU and US on with respect to HVAC systems and manufacturing environments
- Annex 1 of EU GMPs for sterile products
- FDA aseptic processing guide
- Design of an HVAC system: engineering perspective
- URS
- Basis for Design
- System controls: alarms, provisions for power failure, records
- System Specifications
- HVAC balancing: air flows, temperature, humidity, pressures
- Design Qualification: engineering and GMP considerations
- Installation Qualification – an engineering challenge
- Operational Qualification: engineering and quality synergy
- Performance Qualification: are microbiology aspects part of the engineering of the system?
- Preventive and Breakdown maintenance and ongoing control of the system
- Environmental monitoring
- Ongoing qualification
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| Who should attend |
| This course is suitable for any person involved in design, commissioning, qualification, maintenance, production, quality assurance and environmental monitoring programs. |
| About the Speakers |
Karen Ginsbury, B.Pharm, M.Sc, MRPharmS, has over twenty years of experience in the pharmaceutical industry. With a Bachelor of Pharmacy degree from the University of London (“The Square”) and a Master of Science in Microbiology from Birkbeck College, University of London, Karen started off with a well-rounded foundation in the basic skills appropriate to the pharmaceutical industry. She has worked in industry for most of her career, initially in Research and Development at Smith and Nephew in England and then for seven years at Teva Pharmaceutical Industries, today the world’s largest generic manufacturer. After leaving Teva, Karen set up her own consultancy company, PCI Pharmaceutical Consulting Israel Ltd which has been providing services to the pharmaceutical industry worldwide for the past 14 years. PCI regularly works with pharmaceutical, biotech and API manufacturers to assist them in resolving compliance issues with regulatory authorities, in setting up, maintaining and upgrading or improving their quality systems, performing audits at vendors, contract manufacturers, laboratories as well as helping clients successfully prepare for FDA, Health Canada, EU and local regulatory inspections.
Karen was responsible for setting up the compliance department at Teva and published a book on compliance auditing, still available in the USA, that was purchased by most of the multi-national pharmaceutical companies as well as by the US FDA.
Karen regularly lectures around the world on quality topics and is renowned for her lively and engaging style of presentation. She was winner of the Institute of Validation Technology’s “Presentation of the Year Award” in 2006 and their “Webseminar of the Year Award” in 2007.
Karen is also an active volunteer in the Parenteral Drug Association (PDA) and is currently co-editing their Technical Report on GMPs for Investigational Products.
Uri Harel
Founder and Director of H.R.V.A.C. Consulting Engineering Co.Ltd.
Diplom in Mechanical Engineering, from the Technion, Haifa.
Designed HVAC systems for Institutional, Defense, Commercial , and Industrial Projects, mainly in microelectronics, nano, biotechnology and pharmaceutical plants and laboratories
Member at ASHRAE (USA), ISHRAE (ISRAEL), ISPE (INTERNATIONAL), IEST (USA) |
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