Qualification of Pharmaceutical HVAC Systems - Theoretical Course

About this course

This two-day course will cover the basic information required to understand how utilities and HVAC systems fit into the modern pharmaceutical environment and which standards they are expected to perform to by the regulatory bodies.

Discussion and Working Groups

A significant proportion of the course time will be devoted to group work, where delegates have the opportunity, through case studies, to put theory into practice.

Additionally, discussion periods, including a course tutor panel session, provide delegates with an opportunity to obtain answers to their specific questions and concerns.

Course outline

Day One

• Introductions – who are you and why are you here?
• Buzz Group – common questions/issues (HVAC and Utilities)
• HVAC Fundamentals – HVAC language and science for the non-HVAC professional
• Environmental Control Basics – applying HVAC science to the control of critical environments
• Buzz Group – real world HVAC problems (examples)
• Overview of GMP regulations governing HVAC and Utilities (FDA, EU, PIC, WHO):
  • HVAC
  • Water
  • Clean steam
  • Gases
  • Temperature and humidity control
• Wrap-up

Day Two

• Review of Day One
• Buzz Group – most impactful learning
• Typical design considerations by product type in order to control:
  • Cross-contamination (product or process generated)
  • Environmental contamination (external, non-product or process related)
• Assessing fitness for purpose
• Buzz Group – HVAC verification challenge
• Documentation required supporting HVAC verification
• Maintenance and inspections
• Buzz Group – HVAC operational challenge

Venue

Glen Hove Conferencing, Johannesburg, South Africa

Glen Hove Conferencing is centrally located in Johannesburg and close to the very popular Melrose Arch Complex with its superior hotels and dining facilities. Glen Hove Conferencing is the headquarters of the Southern Gauteng branch of the South African Pharmaceutical Society.

For assistance in finding accommodation please contact the Course Convener, Dr A J Thomas on [email protected]

The courses will be held in the ultra modern Upper Glen Hove meeting room which can comfortably seat 80 persons. Acoustics in the room are excellent as is the standard of catering facilities provided. For further information please visit the conference centre’s own website at www.glenhove.co.za or email them at [email protected]

Catering

During the course, mid-morning tea plus snacks will be served at approximately 10.00 with afternoon tea served at 15.00. At lunchtime you can enjoy an appetising finger buffet served in the foyer.

After each day’s activities a closed bar service will be available, chargeable to your account where relevant.

Special Dietary Requirements

If you have any special dietary requirements, please contact the conference management.

Venue Address and Contact Details

Glen Hove Conferencing, 52 Glenhove Road
Melrose Estate, Johannesburg, 2196

PO Box 2467, Houghton, 2041

Tel: 011 442-3601
Fax: 011 442-3678

Tutors

We believe that our team of experts are the best available. Not only have they got years of experience in the industry, but they are committed to tutoring and helping those inside the industry to improve and raise the standards. We understand that you attend courses to learn about the latest regulations and to get your questions answered.

Our expert for this course is:

To Be Confirmed

What you've said

What Previous Attendees Said About This Course

“I have learned a lot and now feel that I am better equipped to address issues regarding HVAC and/or clean utilities.”

Kimberly Ferris, Millennium Pharmaceuticals

“Class very informative. I would recommend it to my associates.”

Lee Donohue, Genzyme Corporation