Webinar

Cleaning Classified Rooms to meet EU Annex 1 requirements

  • Date: Tuesday June 17, 2025
  • Time: 12:00 – 1:30 pm (NY Time)
  • Instructor(s): Jim Polarine and Dan Klein
  • Webinar ID#: ECC-667
Webinar Details:

The presentation will bring clarity to the cleaning and disinfection process by covering current industry trends, global regulatory expectations, and essential elements needed to keep the cleanroom in a state of control. Cleaning and Disinfection is a critical component of the contamination control program during a pandemic. There will be an in-depth discussion on current regulations, disinfectant and sterilant technologies, operator safety, and applications of these products. Application methods and frequencies will be covered. Current industry trends in disinfectant rotation, sterility, application techniques, and rinsing will be discussed. Regulatory expectations of FDA, MHRA, ANVISA, ANMAT, HPRA, EMA, and ANSM inspectors will be discussed. The new Annex I, USP 43 <1072>, PDA Technical Report #70 and other industry guidance documents will be covered as they relate to cleaning and disinfection. The attendees will gain a stronger understanding of current industry trends regarding materials transfer, cleanroom cleaning and cleaning of RABS and Isolators. Current industry FDA Warning Letters and FDA 483s will be covered as teaching tools.

Who Should Attend the Webinar:

  • Validation Managers
  • Quality Control Managers
  • Quality Assurance Managers
  • Lean Managers
  • Operations Managers
  • Cleanroom Managers
  • Regulatory Affairs Managers
  • Production Managers
  • Quality Systems Managers
  • Sustainability Managers

Fee:
$385 for one person
$700 2-5 people
$999 6-10 people

Register for ECC-667