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The A to Z's of Microbial Control, Monitoring and validation of Pharmaceutical Water Systems - Seminar By ComplianceOnline

 
  May 08, 2012  
     
 
ComplianceOnline, Renaissance Newark Airport Hotel 1000 Spring Street, Elizabeth, New Jersey
2012-05-24


Course Description:-

All pharmaceutical, biologics, and medical device facilities are likely to have high purity water systems. In spite of this purity, microorganisms can flourish within these systems and lead to undesirable contamination of facility processes and their products. Of all the individuals at the facility who should understand the microorganisms in water systems and how best to monitor and control and them, it should be the site’s microbiologists. Sadly, this is often not the case due to the lack of familiarity with biofilm and its impact on water system sampling, testing, sanitization, and routine maintenance.

Learning Objectives:-

At the completion of the course, attendees will be able to:

  • Understand the role of system design, maintenance and sanitization in controlling microbial levels in pharmaceutical water systems.
  • Successfully troubleshoot problems resulting from poor design/maintenance versus sampling or testing problems.
  • Devise water system validation protocols that truly validate microbial control.

Who will Benefit :-

This 2-day course is particularly relevant to managers, supervisors, and operatives taking on new responsibilities related to water, but also for experienced water personnel to learn the “true” whys behind what they do and perhaps better ways of doing things. Specific positions that would benefit are:

  • Microbiology Laboratory supervisors and analysts responsible for water sampling and testing
  • Quality Assurance personnel responsible for water system deviation management and change control
  • Regulatory and Compliance professionals responsible for FDA interactions

 

 

 
 
Organized by: ComplianceOnline
Invited Speakers: Speaker name :- T.C. Soli

President of Soli Pharma Solutions, Inc. 

T.C. Soli, Ph.D. , is President of Soli Pharma Solutions, Inc, with lecturing, auditing, and troubleshooting expertise covering water systems, sterilization, aseptic processing, contamination control, and microbiological laboratories. He has over 31 years of pharmaceutical experience as a consultant and with DSM Pharmaceuticals, Glaxo Wellcome, Burroughs Wellcome, and Pfizer. Dr. Soli's career-long water systems and contamination troubleshooting, coupled with water-related USP, ISPE, PhRMA, and PDA committee involvements, afford him practical knowledge about process and contamination control; cleaning, sterilization and process validation; and all aspects of high purity water systems.

 
Deadline for Abstracts: 2012-05-25
 
Registration:

For Registration :-

http://www.complianceonline.com/ecommerce/control/seminar?product_id=80023SEM&?channel=hummolgen 

E-mail: referral@complianceonline.com
 
   
 
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