Webinar: The Building Blocks Of Cleanroom Compliance
Our global compliance 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 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
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 / 9.30am EST
Duration: 20 minute presentation with 10 minutes Q&A
Location: LinkedIn
How to attend: Click the link below to view the webinar on YouTube.
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.
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
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?
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.