
HVAC systems maintain critical GMP (Good Manufacturing Practice) environmental conditions (temperature, humidity, cleanliness, and pressures) in biopharma facilities. The performance, reliability, and regulatory compliance of these systems are essential to GMP operations.
In the end, however, all three objectives (performance, reliability, and compliance) depend on a crucial ingredient: the capability of the team that designs, constructs, operates, manages, and qualifies these HVAC systems.
This training has been specially designed to enhance that capability on two key fronts: (i) Fundamentals of HVAC pharmaceutical design and (ii) HVAC GMP compliance and qualification.
Target Audience
- Professionals working in biopharma manufacturing plants, design, contractors, commissioning & qualifications companies
- Managers, senior engineers, engineers, supervisors, senior technicians
- Involved in HVAC design, construction, commissioning, qualification, maintenance, operations, and GMP compliance
- Professionals aiming to enter the pharmaceutical industry
Training Objectives
- Pharma HVAC facility design: What goes into HVAC pharmaceutical facility design in terms of room classifications, pressure differentials, temperature & relative humidity, AHU configurations, alarms, and types of pharma facilities?
- GMP regulations: What are the HVAC-related FDA, EU, WHO, and ISO GMP regulations/guidelines?
- Compliance: How to qualify the HVAC system for biopharma facilities?
Training outline
Module 1: Pharma HVAC design
- Pharma HVAC: Key considerations (protecting product, people, and environment)
- Starting point: User requirements
- Cleanroom classifications (A, B, C, D, CNC)
- Air changes
- Filtration
- Air distribution
- Room differential pressures
- Temperature and relative humidity requirements
- Alarms, set points, and pressure recovery
- AHU configurations (primary, secondary AHUs, terminal cooling coils and reheating coils)
- Pharma design configurations – Examples (Tableting, sterile facilities)
- Reviewing HVAC design
Module 2: GMP Regulations and compliance
- FDA regulations
- EU GMP regulations
- WHO GMP guidelines
- PIC/S guidelines
- HVAC qualification process and practices
- Design qualification (DQ)
- Installation qualification (IQ)
- Operational qualification (OQ)
- Performance qualification (PQ)
Training Schedule
For the participants in Singapore, Southeast Asia, India, and Europe:
- Module 1: 27 Nov. 2025 (Thu): 2:00 pm – 5:30 pm (Singapore time)
- Module 2: 28 Nov. 2025 (Fri): 2:00 pm – 5:30 pm (Singapore time)
For the participants in the US:
- Module 1: 7 Dec. 2025 (Sun): 6:00 pm – 9:30 pm (U.S. Eastern Time, ET)
- Module 2: 14 Dec. 2025 (Sun): 6:00 pm – 9:30 pm (U.S. Eastern Time, ET)
Trainer: Atul Mathur
- Overall 30 years of experience in HVAC and the last 15 years in pharma HVAC (design, commissioning, qualification, and project management)
- ACTA-certified trainer with 15 years of training experience
- Master’s degree in engineering
- For more information, please visit: Atul Mathur’s LinkedIn profile page
Features
- Relevant & Practical: Designed & delivered by a practitioner with decades of experience.
- Interactive: Highly engaging with questions, discussions, exercises, and experience-sharing.
- Competency-based: Every module starts with clear learning goals and ends with a small quiz.
Testimonials
A few testimonials from the participants who attended the recent runs of this training (20 Aug. & 21 Aug. 2025):
The training session was highly informative and well-structured. Atul did an excellent job of focusing on the key points of the subject, making it easy to follow and understand. Complex topics were broken down clearly, and the practical examples helped reinforce the main concepts. Overall, it was a valuable learning experience.
E.T. (Rieckermann)
Question and answer format was very engaging. Technical content, industry standards and GMP regulations were simplied and made easy to understand.
S.Q. (Lonza)
The presentation of topics using simple sketches, explained clearly and in great detail. Cleanroom classifications, EU& FDA regulations, URS preparation, commissioning & qualification steps clealry explained.
R.V. (ThermoFisher)
The industry insights that can only come from decades of experience.
P.E. (Abbvie)
Fee
- Standard fee: SGD 350/pax
- Discounts
- Early registration by 13 Nov. 2025: SGD 280/pax
- Group registration (2 or more pax) by 13 Nov. 2025: SGD 250/pax
- The fee is fully refundable if, after the training, you feel the training was not worth the fee.
How to register
- To register, simply fill up the Training Registration Form
- For any queries, please feel free to contact at hvac.cq@gmail.com
