| |
|
|
|
The Center for Professional Advancement, An Online Training Format
June 24, 2008 at 11:00 a.m. - 12:30 p.m. (EST–New York time)
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 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 ContaminationSources of microbial contamination in manufacturing processesRole of microbial biofilms
Module 2:
Definition of disinfection, sterilization, and preservationUse of heat, ionizing radiation, ethylene oxide and filtration as sterilization methodsDisinfection versus sterilizationResistant organisms
Module 3:
Laboratory role in microbial contamination controlFacility monitoring and training of personnelTesting for microbial contamination: Rapid testing versus conventional methodsQuestions & Answers
|
|
|
|
|
|
|
|
Organized by:
|
|
The Center for Professional Advancement |
|
|
Invited Speakers:
|
|
Daniel J. Spangler, M.S., Consultant, Microbial Contamination Solutions, LLC.
Daniel Spangler has over 20 years experience in Microbiology/QC laboratory management roles in the manufacture of OTC, sterile, and parenteral drugs (Coopervision, IOLAB, OMJ Pharmaceuticals, Enzon Pharmaceuticals, and Bristol Myers-Squibb) and sterile medical devices (Ethicon, Inc.). He also has 3 years experience as Principal Scientist in medical device R&D (Ethicon, Inc., Arrow International, Inc., and Teleflex Medical). In his microbiology management role, Dan has gained hands on knowledge and expertise regarding the sources of microbial contamination in manufacturing processes, and has developed insight into contamination prevention, process troubleshooting, and remediation. He has shared his experience and expertise in presentations at numerous corporate level and professional conferences (ASM, Puerto Rico Chapter) on control of microbial contamination in water systems and investigation of sterility test failures.
|
|
|
|
|
|
|
|
Deadline for Abstracts:
|
|
n/a
|
|
|
|
|
|
|
|
Registration:
|
|
Please click here for registration information.
|
|
|
E-mail:
|
|
info@cfpa.com
|
|
|
|
|
|
|
|
|