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Microbiology Current Practice: Drug and Devices

 
  June 16, 2017  
     
 
CfPA-The Center for Professional Advancement, New Brunswick, NJ
July 20-21, 2017


Who Should Attend?
The course is designed for professionals in the medical device, biotechnology and pharmaceutical industries including:

  • Those needing a basic knowledge of microbiology as it affects their function
  • Microbiology personnel who wish to get updated on new, more reliable rapid 
     testing, monitoring and identification methods and problem solving
  • Audit personnel needing more background in the microbiological aspects to 
     be considered when auditing
  • Personnel with little background in microbiology, such as manufacturing, 
     validation, and facilities staff that need to gain a better understanding of 
     how to better deal with microbiological issues

Course Description
This course will present information on microbiological control in manufacturing, laboratory auditing and sterilization. The course will also cover ISO, EP, BP, USP, AAMI and U.S. FDA documents and guidelines. Validation of sterilization processing will be discussed and case studies will be presented. Environmental monitoring programs will be discussed in depth. Design and testing of product packages for sterility assurance will be covered via case studies. All aspects of microbiological control will be covered. Microbiological testing schemes will be presented and the key aspects of GLP/cGMP will be reviewed.

Participants are encouraged to bring samples of their own monitoring programs, procedures, flowcharts, etc. for discussions during the case studies.
 
 
Organized by: CfPA-The Center for Professional Advancement
Invited Speakers:
William G. Marshall; President, William G. Marshall & Associates

William G. Marshall is President of William G. Marshall and Associates. He has over forty years of experience in the Pharmaceutical and Medical Device Manufacturing Environment. Mr. Marshall has held Director level and Chief Operating Officer positions with large multinational pharmaceutical corporations as well as start-up ventures. He has been the Director of a major reference laboratory, and has been active in clean room design and validation. In the last five years, he has acted as a third party in several consent decrees.

Mr. Marshall is currently a consultant to the worldwide drug and device industry as well as to the FDA. He lectures worldwide in GMP related issues including Clean Room Technology and Sterilization. In the past 18 months, he has been involved in 10 Pre- Approval Inspections that include the first aseptic processed injectables from India, the first ever drugs from Turkey, and APIs from China, that were all approved for introduction to the US market. He has a Master’s Degree in Biology from Georgetown University, Washington, DC.

Mr. Marshall’s training continues to receive CfPA’s most highly rated reviews. He liberally uses Case Studies from Warning Letters and Consent Decrees and his 40 plus years working in manufacturing and consulting in over 25 countries. Attendees are encouraged to question , debate , and share their own problems and successes. Mr. Marshall’s style of training is to keep the course very interactive. Attendees find his enthusiasm, knowledge, and experience, wrapped in a sense of humor, stimulating as well as informative.
 
Deadline for Abstracts: n/a
 
Registration: Please click here for registration information.
E-mail: jmorbit@cfpa.com
 
   
 
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