In-house Courses
Designing a Compliant Cleaning and Disinfection Program for Controlled Environments
OUTLINE
Contamination prevention in your manufacturing facility begins with the choice, qualification, and proper application of disinfectants during cleaning. Cleaning and disinfecting a manufacturing suite is a science, not an exercise.
Understanding disinfectant qualification methods and the translation of this qualification to cleaning procedures is the key to avoiding contamination and its pitfalls such as failed media fills or sterility tests. Use your environmental monitoring trending data to develop effective disinfectant efficacy studies and implement robust cleaning procedures to prevent contamination in your manufacturing facility to ensure your product’s integrity.
Key Topics
- Control of contamination in controlled areas
- Cleaning the environment and contending with residues
- Destruction of viable contamination and validation of disinfectants (Antimicrobial Effectiveness, In-situ, Open Container)
- Rotation and addressing theoretical resistance and built immunity
- Application of disinfectants and application devices
- SOP's and Training
Who Should Attend
- Quality Assurance personnel responsible for environmental conditions in controlled environments
- Manufacturing or Production Service personnel responsible for cleaning and disinfection of controlled environments.
- Validation personnel who will be required to validate the use of cleaning agents.
Learning Objectives
At the completion of this course, attendees will be able to:
- Control contamination from entering controlled areas.
- Clean and disinfect the environments
- Develop validation protocols for appropriate implementation of systems and chemical agents.
- Train personnel in appropriate methods of cleaning and disinfection.
- Understand regulatory guidelines and expectations.
- Undergo previous training presented to FDA's CDER and CBER divisions
Please Note:
It is our intent to make our course a helpful to you as possible. It is offered through the Microbiology Network, and taught by recognized experts in the field. If you have a topic of special interest, or any questions of particular importance to you, please let us know in advance. This will allow the instructors an opportunity to incorporate your concerns into the course. We know how critical your time and money are, and will do everything possible to ensure ensure that you get value from this experience.
Note: This course is being offered in cooperation with the Microbiology Network
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