Intensive training in all aspects of environmental monitoring, disinfectant qualification, and cleanroom contamination control
April 24, 2007 — /MEDICAL INDUSTRY E-MAIL NEWS SERVICE(TM)/ — SAN JOSE, CA — Microrite announced details today of its popular training course on all aspects of environmental monitoring, disinfectant qualification, and cleanroom contamination control, set for June 7-8, 2007, at the Doubletree Suites in Boston MA.
SCHEDULE:
DAY 1
Environmental Monitoring – A Complex System Simplified
Correct use of EM data will help you maintain control of your facility. This data will provide critical manufacturing facility condition information at a glance. This seminar will provide the tools to establish compliant and practical environmental monitoring programs and the keys to using the data to control contamination
This seminar will include:
- Discussion on the various cleanroom classification schemes, EM regulations, and guidances
- Guidance on setting up a meaningful EM plan, including number and location of sites
- Microbial identification, when it is necessary and why
- Discussion on choice and evaluation of equipment for EM
- How to create a plan to track and trend EM data, and when and why to identify EM isolates
- Discussion on evaluation of microbial identification systems
- Guidance on trending EM data, in order to retrieve important information on the condition of the manufacturing facility
- Overview of the key components of EM summary reports that will provide rapid review of EM controls and precisely relate this to the manufacturing facility condition
- EM-related investigations, what to look for and where
- How to evaluate automated systems for EM
- Discussion on FDA 483 observations on EM and data trending
DAY 2
Understanding the Qualification of Disinfectants and Key Elements of Cleaning Procedures
Contamination prevention in 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 EM 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
This seminar will include:
- Detailed discussion of bacterial and fungal contamination in cleanrooms, their source and quantities
- Disinfectants commonly used, their modes of action, efficacy, and toxicity
- Create your own plan; use your EM data to choose the disinfectants and cleaning frequencies
- Discussion on current methods used in the industry to qualify disinfectants
- Tools to develop an effective disinfectant qualification program
- Commonly observed deficiencies in disinfectant qualification studies that may lead to observations
- Translation of disinfectant qualification results to cleaning procedures to prevent contamination
- Discussion on FDA 483 observations related disinfectant qualification and cleaning procedures
- Case studies where errors in choice of disinfectants or disinfectant qualification have lead to major contamination issues
For the complete course brochure:
http://sacserv.com/tracking.jsp?linkid=88517
Contact:
Ziva Abraham
Microrite, Inc.
5019 New Trier Ave
San Jose CA USA 95136
408-445-0507 phone
408-445-1236 fax
[email protected]