Course offering number:0811-704
Course ID:
2215
Control of Microbial Contamination in Manufacture of Sterile and Non-Sterile Products
Pre-recorded Course
AN ON-DEMAND 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 accredited online course provides an overview of the sources of microbial contamination and how to control such contamination.
While many of the concepts presented relate to the manufacture of sterile drugs and devices, much of the material is also applicable
to non-sterile products. Products contaminated with microorganisms can cause infection in the end user and result in significant
financial loss to the manufacturer due to rejected product, recalls and litigation. In this course, you will gain an understanding of what
microbial contamination is its sources, and what steps can be taken to reduce the risk of such contamination. Disinfection,
sterilization and preservation will be discussed in terms of relevance and limitations. Other elements will also be addressed, including
the importance of properly designed processes, equipment and training of personnel. The advantage of rapid methods over traditional
microbiological testing will also be discussed.
Module 1:
• Definition of Microbial Contamination
• Sources of microbial contamination in manufacturing
processes
• Role of microbial biofilms
Module 2:
• Definition of disinfection, sterilization, and preservation
• Use of heat, ionizing radiation, ethylene oxide and filtration
as sterilization methods
• Disinfection versus sterilization
• Resistant organisms
Module 3:
• Laboratory role in microbial contamination control
• Facility monitoring and training of personnel
• Testing for microbial contamination: Rapid testing versus
conventional methods
Questions & Answers
OTHER PARTS IN THIS SERIES:
Investigation of Microbial Contamination in Sterile and Non-Sterile Products
(Course Offering # 0808-702)
Attend both parts and SAVE $100 OR take either as a stand-alone course. Take both to maximize learning and minimize expense.