The A to Z's of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems (Sep 11 - 12, 2017)
In-Person Event
Sep 11 - 12, 2017
Sydney, New South Wales, AUSpeakers
OVERVIEW
The A to Z's of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems is organized by GlobalCompliancePanel and would be held during Sep 11 - 12, 2017 at Hilton Sydney, Sydney, New South Wales, Australia. This CME Conference has been approved with a maximum of 12 Credits.
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
• Process and Utility Engineers responsible for water system maintenance, repairs, troubleshooting, and excursion mitigation
• Facility Engineers responsible for water system design or renovation
• Validation personnel for water system qualification
• Change Control personnel involved in water system changes and repairs
• Production Managers involved with water system use for manufacturing and cleaning
• Laboratory Managers and Supervisors responsible for lab water systems and other water sources
Description :
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 because engineers and other non-biologists also need this training if they are involved with any aspect of water systems. The instructor will provide the necessary background needed to understand this very important subject matter. This understanding is essential to the proper design, validation, operation, monitoring, maintenance, troubleshooting, and excursion investigations 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, and leaves the user without a clue as to what went wrong or how to effectively fix it so it doesn't recur.
Why you should attend :
Much fear and hype exists with pharmaceutical biofilms, especially those in water systems. Long term biofilm control cannot be achieved from a blind set of hand-me-down rules for design and operation. One must truly understand biofilm to be able to control it. And because every water system is unique, understanding how biofilm is trying to grow in your system, which could be different than any other system. This course will give you that understanding that is translatable to any system, so that uneventful microbial control is possible. Without this understanding you will quickly find that blind rules for operation (and design) eventually fail to work, and the consequences of failure will far exceed the educational costs that could have prevented it.
Speaker :
Teri C. ("T.C.") Soli, Ph.D. is President of Soli Pharma Solutions, Inc, serving the Pharmaceutical, Biotech, Medical Device, Dialysis, Cosmetics and Personal Care Products and related equipment and instrument manufacturing industries with training, auditing, and troubleshooting expertise. He has over 32 years of combined pharmaceutical experience as a consultant as well as with operating companies such as DSM Pharmaceuticals, Glaxo Wellcome, Burroughs Wellcome, and Pfizer. Dr. Soli's career-long experience with water systems and product and process contamination troubleshooting, coupled with USP, ISPE, PhRMA, and PDA committee involvements, afford him practical knowledge and troubleshooting skills with contamination control, cleaning, sterilization, sterile and non-sterile processes, validation, laboratory testing, excursion investigations and all aspects of high purity water systems.
He is in his third 5 year term on USP Expert Committees responsible for Pharmaceutical Water, is the author of USP's Informational Chapter <1231> on pharmaceutical water, and helped develop the Water Conductivity and TOC specifications used by USP and adopted world-wide. He has motivated many audiences and course attendees with practical water system information. He has also authored many articles and chapters in books and industry standards published by PDA and ISPE including chapter authorships in the 2nd ed. ISPE Baseline Guide for Water and Steam Systems, ISPE's Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Systems, and chapters in several PDA books on pharmaceutical and laboratory water systems and biofilm control. He earned a Ph.D. degree in Microbiology and Immunology from the University of Arizona and M.S. and B.S. degrees in Microbiology from Texas A&M University.
Price :
Register now and save $200. (Early Bird)
Price: $1,695.00 (Seminar Fee for One Delegate)
Until August 10, Early Bird Price: $1,695.00 From August 11 to September 09,
Regular Price: $1,895.00
Register for 5 attendees Price: $5,085.00
Register for 10 attendees Price: $9,322.00
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
• Process and Utility Engineers responsible for water system maintenance, repairs, troubleshooting, and excursion mitigation
• Facility Engineers responsible for water system design or renovation
• Validation personnel for water system qualification
• Change Control personnel involved in water system changes and repairs
• Production Managers involved with water system use for manufacturing and cleaning
• Laboratory Managers and Supervisors responsible for lab water systems and other water sources
Description :
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 because engineers and other non-biologists also need this training if they are involved with any aspect of water systems. The instructor will provide the necessary background needed to understand this very important subject matter. This understanding is essential to the proper design, validation, operation, monitoring, maintenance, troubleshooting, and excursion investigations 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, and leaves the user without a clue as to what went wrong or how to effectively fix it so it doesn't recur.
Why you should attend :
Much fear and hype exists with pharmaceutical biofilms, especially those in water systems. Long term biofilm control cannot be achieved from a blind set of hand-me-down rules for design and operation. One must truly understand biofilm to be able to control it. And because every water system is unique, understanding how biofilm is trying to grow in your system, which could be different than any other system. This course will give you that understanding that is translatable to any system, so that uneventful microbial control is possible. Without this understanding you will quickly find that blind rules for operation (and design) eventually fail to work, and the consequences of failure will far exceed the educational costs that could have prevented it.
Speaker :
Teri C. ("T.C.") Soli, Ph.D. is President of Soli Pharma Solutions, Inc, serving the Pharmaceutical, Biotech, Medical Device, Dialysis, Cosmetics and Personal Care Products and related equipment and instrument manufacturing industries with training, auditing, and troubleshooting expertise. He has over 32 years of combined pharmaceutical experience as a consultant as well as with operating companies such as DSM Pharmaceuticals, Glaxo Wellcome, Burroughs Wellcome, and Pfizer. Dr. Soli's career-long experience with water systems and product and process contamination troubleshooting, coupled with USP, ISPE, PhRMA, and PDA committee involvements, afford him practical knowledge and troubleshooting skills with contamination control, cleaning, sterilization, sterile and non-sterile processes, validation, laboratory testing, excursion investigations and all aspects of high purity water systems.
He is in his third 5 year term on USP Expert Committees responsible for Pharmaceutical Water, is the author of USP's Informational Chapter <1231> on pharmaceutical water, and helped develop the Water Conductivity and TOC specifications used by USP and adopted world-wide. He has motivated many audiences and course attendees with practical water system information. He has also authored many articles and chapters in books and industry standards published by PDA and ISPE including chapter authorships in the 2nd ed. ISPE Baseline Guide for Water and Steam Systems, ISPE's Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Systems, and chapters in several PDA books on pharmaceutical and laboratory water systems and biofilm control. He earned a Ph.D. degree in Microbiology and Immunology from the University of Arizona and M.S. and B.S. degrees in Microbiology from Texas A&M University.
Price :
Register now and save $200. (Early Bird)
Price: $1,695.00 (Seminar Fee for One Delegate)
Until August 10, Early Bird Price: $1,695.00 From August 11 to September 09,
Regular Price: $1,895.00
Register for 5 attendees Price: $5,085.00
Register for 10 attendees Price: $9,322.00
KEY DATES
11 Sep, 2017
Event Start Date
12 Sep, 2017
Event End Date
SPECIALITIES
Pharmacy and MedicineSUGGESTED HOTELS
CONFERENCE VENUE
Hilton SydneyRELATED CONFERENCES & LIVE WEBINARS
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