Global Best Practices for Cleaning and Disinfection of Cleanrooms and Disinfection Validation
Date: Thursday, 18 October 2018
Time: 10:00 AM PDT, 01:00 PM EDT
Duration: 60 Minutes
Cleaning and disinfection of cleanrooms is of great importance as part of a contamination control strategy. For this to be effective, correct disinfectants need to be selected, rotation between biocides must in place, a sporicidal agent needs to be selected, disinfectants need to be qualified cleaning frequencies need to be established, and appropriate training given. This is hampered by the lack of a global approach to satisfy regulatory agencies. This webinar provides an overview of the focal points required to achieve a global approach for cleanroom disinfection.
Objectives of the Presentation
Why Should you Attend
- What is cleaning and disinfection?
- How to select disinfectants?
- Global guidelines for disinfection in cleanrooms
- EU GMP (& draft Annex 1), USP <1072>, FDA aseptic processing guidance, PIC/S
- How to use disinfectants effectively
- Points for success
- Approaching disinfectant validation: Differences between European and U.S. standards
- Practical approach to disinfectant validation: what is best for pharma?
- Legal requirements for disinfectants: Europe and U.S.
To understand the concerns expressed by regulators in relation to cleaning and disinfection and to consider how application and qualification of detergents and disinfectants can be approved in order to satisfy competing regulatory demands, that is to identify the key features of a global approach for cleaning and disinfection of cleanrooms and disinfection validation.
Who will Benefit
- Differences between types of disinfectants
- Disinfectant efficacy testing
- Regulatory citations
- Latest laws and regulations
- Cleaning and disinfectant policy and procedure points
- Developing global standards
- Quality Assurance
- Quality control
In recent years there have been a number of regulatory citations relating to cleaning and disinfection practices, in terms of techniques and inadequate qualification. In addition, companies operating globally face a problem of how to meet the differing international standards. This webinar provides an opportunity to understand the GMP deficiencies and to develop a qualification approach to meet global regulatory expectations.