HVAC and Water Systems in a GMP Environment

GMP Engineering and Validation Operations Quality Assurance @Biotech Training Facility

Explore and gain insight into the operation of HVAC and water systems under the guidance of a GMP expert and technical experts.

Location

Biotech Training Facility

Duration

1 dag

Course fee

€ 995.00 (excl. VAT)

Short Description

This course covers the fundamental principles of GMP (and ISO guidelines) and stands out due to the involvement of technical experts who share their professional knowledge during an extensive on-site tour. Theory is valuable but seeing how it works in practice makes the learning experience even more effective!

Under the guidance of technical experts, participants visit the technical areas, where they can directly observe the concepts explained in the theory. The course concludes with an interactive workshop, where participants work in small groups on a case study addressing an issue in the WFI and/or HVAC system.

Objectives

  • Gain insight into HVAC and water systems: understand how HVAC and water systems operate within a GMP environment and their role in pharmaceutical production.

  • Regulations and quality standards: learn about the relevant GMP guidelines, European Pharmacopoeia and FDA requirements for HVAC and water systems.

  • Problem solving and monitoring: learn how to monitor and test water systems and cleanrooms, and how to analyze problems through case studies.

  • Practical application: link theory directly to practice through guided tours, demonstrations and technical explanations from experts.

Target Group

  • Technical people working in facilities, technical engineering or maintenance, who are junior in their field of expertise.

  • QA staff who would like to better understand what may be the cause of deviations and improve communication and collaboration with technical staff.

  • Auditors who would like to have more knowledge of HVAC and/or WIFI systems.

  • Technical production staff.

  • Anyone working at a start-up who would like to understand more about this topic, for example inthe context of building a facility.

Program