Events
-

Webinar: The Building Blocks Of Cleanroom Compliance

Our global compliance and quality assurance team will be conducting a webinar titled “The Building Blocks of Cleanroom Compliance” where we will explore topics such as:

  • When is regulatory compliance necessary?
  • Developing a User Requirement Specification (URS) and why this is important
  • Pre-project compliance
  • Project compliance throughout the cleanroom build process – DQ, IQ, OQ & PQ
  • Maintaining compliance during cleanroom use
  • Servicing & requalification of GMP facilities
  • Regulatory inspections
  • Regulatory updates & EU-GMP Annex 1

Don’t miss this unique opportunity to listen to our industry professionals and ask questions directly to the experts!

Date & Time: 10th April 2024 at 1.30pm GMT / 8.30am EST

Duration: 20 minute presentation with 10 minutes Q&A

Location: LinkedIn

How to attend: Click the link below to sign up and register your interest in attending. We will then send a link for you to join the webinar nearer event date.

SIGN UP TODAY

The Building Blocks of Cleanroom Compliance

Our regulatory governance team have a combined experience of over 30 years in the GMP cleanroom industry and are well versed in navigating the requirements of governing bodies when it comes to regulatory compliance. This webinar aims 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

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 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.

 

 

FIND OUT MORE

What will be covered?

We will cover topics including, but not limited to:

  • 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 – 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?

Who is this webinar for?

This webinar is 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
  • Is looking for regulatory governance consultancy

 

Date & Time: 10th April 2024 at 1.30pm GMT / 8.30am EST

Duration: 20 minute presentation with 10 minutes Q&A

Location: LinkedIn

How to attend: Click the link below to sign up and register your interest in attending. We will then send a link for you to join the webinar nearer event date.

REGISTER TO ATTEND