Debates and Challenges Concerning Disinfectant Validation and Methods to Circumvent Them
Monday October 22, 2018
12:00 Noon – 1:30 pm EDT
Instructor: Jim Polarine
This presentation covers current debates in the industry regarding disinfectant coupon testing. PDA Technical Report No. 70 and USP 39 <1072> will be covered in relation to current industry disinfectant efficacy testing. 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, and HPRA regulatory expectations and reducing the costs for testing.
Areas Covered in the Seminar:
- Effective ways to validate disinfectants, sanitizers, and sporicides
- The most common causes for coupon testing failures
- The most current industry methods for conducting coupon testing
- Developing risk assessments for choosing environmental isolates and coupon surfaces
- Current global regulatory guidance on disinfectant validation
Who Will Benefit:
This webinar will provide valuable assistance to all FDA and EMA regulated companies that need to validate their cleaning and disinfection programs, including companies in the Pharmaceutical, Biotech, and Medical Device fields. The employees who will benefit include:
- QA and QC Managers
- Disinfectant Validation Managers
- Operations Managers
- Cleanroom Managers
- Personnel and contractors that clean and disinfect cleanrooms
- EH&S Managers
- Regulatory Compliance Managers & Environmental Monitoring Managers
Fee:
$385 for one person
$700 2-5 people
$999 6-10 people
Questions? support@eccwebinars.com
ECC-053