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Course offering number:0807-404
Course ID:
2216
Investigation of Microbial Contamination in Sterile and Non-Sterile Products
July 22, 2008 at 11:00 a.m. - 12:30 p.m. (EST–New York time)
AN ONLINE TRAINING FORMAT
Who Should Attend
This course is intended for persons who are directly involved with the manufacture of sterile drugs and medical devices, as well as other products that are required to be free of certain objectionable organisms. It is recommended for:-
Production Managers
- QC/QA Managers
- Environmental Monitoring Personnel
- QC/QA Lab Personnel
- Process Design/Engineering Personnel
- Maintenance Managers
Description
This 90-minute online course provides an overview of the investigation of microbial contamination in manufacturing processes and products. Product contamination can cause infection in the end user and can result in financial loss to the manufacturer. Detection of microbial contamination requires prompt attention. A positive test for microbial contamination in product will be discussed and the analogy made to a criminal investigation. The formation of a cross-functional team is essential to the investigation process. Investigation basics will be presented along with specific known problematic organisms. Examples of design flaws, inadequate maintenance, lab induces failures and other problems that can lead to product contamination will be provided.
Module 1:-
Definition of microbial contamination and its potential root causes
- The importance of microbial identifications to the investigation process
- Investigation basics
Module 2:-
Identifications of microbial contaminants as clues to the source
- The laboratory as a source of microbial contamination
- Microorganisms with known resistance to sterilization processes
Module 3:-
Water as a source of microbial contamination
- Design flaws and system failure examples leading to microbial contamination of product
- The laboratory as a source of false positive tests
- Question & Answer