A look back at our first webinar of 2024, Building Blocks of Cleanroom Compliance

On Wednesday 10 April 2024, our Regulatory Governance team hosted our first webinar of 2024, The Building Blocks of Cleanroom Compliance, where we were delighted to welcome over 70 attendees!

The webinar consisted of a 20 minute presentation followed by 10 minutes of Q & A. For those of you that missed it, the full video is below!

The Building Blocks of Cleanroom Compliance

Regulatory Governance Team

Our regulatory governance team have a combined experience of over 30 years in the GMP cleanroom industry. They are well-versed in navigating the requirements of governing bodies when it comes to regulatory compliance. This webinar aimed to explore what regulatory compliance is, when it should be taken into consideration and the tools & support that are available to assist in regulatory inspection preparation.

Joan Benson - Regulatory Governance ManagerJoan Benson

Global compliance and quality assurance manager

Joan has 30 years previous experience in Cell and Gene Therapy, Academia, Pharmaceutical Industry, Contract Clinical Research and Hospital Aseptic facilities. She was front facing regulatory inspections in MHRA, FDA, HTA and HFEA for 20 years.

Simon Rice - Global Compliance Lead

Simon Rice

Global compliance lead

Simon has 8 years previous experience in the production of radiopharmaceuticals within a fully accredited GMP facility manufacturing sterile pharmaceuticals. This gives him a unique understanding on the implications of GMP.

The Webinar

The webinar aimed to share knowledge with peers, covering:

  • When is regulatory compliance necessary?
  • Developing a User Requirement Specification (URS) and why this is important.
  • Pre-project compliance such as layout, process flow, and choosing the correct cleaning & disinfection tools and how they interact with the materials used for building the room.
  • Project compliance throughout all stages of the build process
  • Qualification of the facility using DQ, IQ, OQ & PQ
  • Maintaining compliance during cleanroom use
  • Servicing & requalification of GMP facilities
  • Regulatory inspections
  • Regulatory updates & EU GMP Annex 1 – How to maintain compliance?

The webinar was aimed at anyone who works in a GMP cleanroom facility or laboratory, is responsible for maintaining cleanroom compliance, is in the process of building a GMP cleanroom facility or is looking for regulatory governance consultancy.

Questions & Answers

At the end of the webinar, there was time for Q&A, where the following questions were raised:

GMP Cleanroom Render


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