Tuesday June 4, 2024
12:00 Noon – 1:30 pm (NY Time)
Instructor: Jim Polarine
Abstract:
This presentation covers current debates and challenges in the industry regarding disinfectant coupon testing and disinfectant field trials. Annex I (2022), PDA Technical Report No. 70, IEST RP 018.5, and USP 43 <1072> will be covered in relation to current industry disinfectant efficacy testing and disinfectant field trials. Recent FDA Warning Letters and 483s will be covered that highlight regulator expectations in disinfectant efficacy testing. Data will be presented covering the importance of disinfectant efficacy testing with specific bacterial spores which can be more difficult to kill than ATCC strains. Both sides of the debate on disinfectant validation will be covered in detail with an emphasis on current FDA, MHRA, ANVISA, ANSM, CFDA, and HPRA regulatory expectations and reducing the costs for testing. The recent USP 43 <1072>, PDA Technical Report No. 70 recommendations on DET (Disinfectant Efficacy Testing) will be discussed. There will be a practical demonstration of the different types of coupon testing for the US and Europe.
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
- Continuous Improvement Managers
- Sustainability Managers
Fee:
$385 for one person
$700 2-5 people
$999 6-10 people
Questions? support@eccwebinars.com
ECC-607