Dr. Soli has been consulting for 12 years, serving the pharmaceutical, biological, and medical device industries with training and troubleshooting expertise covering water systems, sterilization, aseptic processing, microbiological and beta-lactam contamination control, and microbiological laboratory operations. He has 29 years of diverse pharmaceutical experience beginning with Pfizer and ending with DSM Pharmaceuticals (formerly Catalytica, Glaxo Wellcome, and Burroughs Wellcome) before moving into full time consulting. That experience spanned the disciplines of Chemical and Microbiological Development, Quality Operations, Aseptic Process and Sterilization Validation, Regulatory Affairs, and Project Management. His career-long involvement with pharmaceutical microbiology and participation with pivotal industry water committees, coupled with his extensive consulting experience afford him valuable practical knowledge of all aspects of contamination control, quality operations, microbiological testing, and high purity water systems with an ability to troubleshoot complex microbiological issues and communicate the results and recommendations. He has lectured extensively and authored numerous papers and several book chapters for PDA and ISPE publications, and is Vice-Chair of the USP Pharmaceutical Waters Expert Committee through which he has authored or co-authored several USP Monographs, and Chapter revisions, including his complete rewrite of USP's "pharmaceutical water bible", Chapter <1231>. Prior to this, he served on the PhRMA Water Quality Committee that derived the now globally used USP Water Conductivity and TOC tests and specifications. He holds B.S. and M.S. degrees in Microbiology from Texas A&M University and a Ph.D. in Microbiology and Immunology from the University of Arizona.
Presentation Materials, Luncheon, Refreshment and Free Parking
Note: Please indicate any special Dietary requirements when registering for the course
September 20-21, 2011
CAD $895.00 + HST
AAPS Training Center
200 Consumers Road, Suite 200, Toronto, Ontario, M2J 4R4
Tel: 416-502-2277
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. This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement. The instructor can provide the necessary background needed to understand this very important subject matter. This understanding is essential to the proper design, validation, operation, monitoring, and maintenance of a high purity water system. Without this understanding, water system control consists of a set of rules that often don't work and can cause very costly system downtime or even product recalls.
In order to understand the microbiology of a water system, one has to understand biofilms since that is the mode of microbial growth in a water system. There is much hype and fear about water systems biofilms by users and regulators alike who do not understand how they grow, how to effectively control that growth, or even how to monitor their presence. This course will help you understand how microorganisms respond to our efforts (or lack of effort) to control their numbers and even to how we try to count them.
A key resource for this course is the latest revision of the USP informational chapter on water <1231> "Water for Pharmaceutical Purposes", first published in Supplement 2 to USP28 and current through USP 32. The course instructor is the primary author of that revised chapter.
At the completion of the course, attendees will be able to:
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