"2-day In-person Seminar on The A to Z's of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems New Jersey"
View this email in your browser | Unsubscribe from future mailings 2-day In-person Seminar on The A to Z's of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems Course "The A to Z's of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems" has Register Now been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Date & Time: Instructor Profile: October 11th and 12th 2012 8 AM to 5 PM EDT Teri C. Soli Duration: 2 Days Instructor: Teri C. Soli Principal Consultant, Soli Pharma Solutions Price : $1295.00 (for one Location: New Jersey participant) T.C. Soli, is a Ph.D. Microbiologist Register for 4 Participants to Get 1 Free Pass and President of Soli Pharma Solutions, Inc. (www.solipharmasol.com), and since becoming a full time consultant, has Overview: served consumer products and FDA- This course is designed to provide a microbiology-focused education regulated industries with training and about all aspects of water systems and how biofilm manages to troubleshooting expertise covering thrive there. water systems, sterilization, aseptic processing, microbiological and beta- lactam contamination control, Prior microbiological education or training, though a plus, is not a microbiological laboratory requirement because engineers and other non-biologists also need operations, and has served as a this training if they are involved with any aspect of water systems. pharmaceutical expert witness in The instructor will provide the necessary background needed to several "contamination" litigations. understand this very important subject matter. This understanding Prior to full time consulting, he had is essential to the proper design, validation, operation, monitoring, 25 years of diverse "Big Pharma" maintenance, troubleshooting, and excursion investigations of a high operating company experience. purity water system. Without this understanding, water system During his 31+ year career he has lectured extensively at conferences, control consists of a set of rules that often don’t work and can cause authored numerous papers and very costly system downtime or even product recalls, and leaves the recently written several book user without a clue as to what went wrong or how to effectively fix it chapters related to water system so it doesn't recur. microbiology for USP, PDA and ISPE publications. He is currently serving in his third five-year term on USP Course Outline: Expert Committees responsible for Pharmaceutical Waters through Course Outline: Day 1: which he authored the complete rewrite of USP Chapter <1231> Lecture 1: What Makes Water Systems Have Microbial Quality which many consider to be USP's "pharmaceutical water bible". Problems ...more l Understand biofilm basics and how it develops l Understand the impact of biofilm on the commonly used purification unit operations Suggest a Topic More Webinars l Understand how various commonly used microbial control Your Necessity is our Priority strategies work (or don’t work) to control biofilm development l Understand the how, where, and why of microbial monitoring, action levels, etc. l Debunk a few water system myths l Get answers to your own water system questions Lecture 2: Successful Sanitization Approaches for Trouble-Free Water Quality l Material and construction limitations l Continuous vs intermittent sanitization l The importance of biofilm removal l How sanitants work (or don’t work) l When to sanitize l Troubleshooting sanitization problems Lecture 3: Water System Validation by Logic Instead of Tradition l Why validate a water system? l Basic ground rules for water systems before you validate them l Micro Test Method “validation” l Minimum validation expectations l How to figure out what you should validate l What happens after the honeymoon is over l Is validation ever really over? l Special considerations for lab water systems l Are packaged waters a viable option? Lecture 4: Implementing Changes to a Validated System l Purpose of a Change Control program – a help, not a hindrance l When is a change major vs minor, requiring full vs limited re- qualification? l What about water use during re-qualifications? l FDA validation expectations l Reliance on logic and common sense and the disservice of precedent and paradigms l Additional useful tips Lecture 5: Reducing Water Microbial Excursions & Improving Investigations l What are excursions? l Water system dilemma: process control or quality control (utility or raw material), or both l Intended roles of Alert/Action Levels and Specifications l Investigation, necessary and often fruitless l Excursion responses and impact l Criticality of valves, hoses, & outlet flushing l Diagnosing the source of the problem l Minimizing unnecessary excursion responses through best practices Course Outline: Day 2: Lecture 6: Understanding and Controlling Endotoxin l Where does endotoxin come from? l What are the properties of endotoxin ? l How do you get rid of it? l How do you detect it? l What assay controls are used? l What are the endotoxin specs for water? l How do you control it? Lecture 7: Harmonizing vs Optimizing Water Microbial Testing for System Quality Control l Water harmonization that has occurred l Water Micro TM “Dis-Harmonization” l A little about Biofilm l Biofilm diversity in water systems l Micro TM options and evaluation protocol l The good and bad of Micro harmonization l Where RMMs can fit in l Parting wisdom Lecture 8: Microbial Enumeration Issues with High Purity Water Systems l Biofilm enumeration issues (planktonic vs surface) l Traditional cultivative approach issues l Validation of your test method l Alternative TM choices (advantages/disadvantages) l Significance of water isolates l Sampling issues l Establishing Alert/Action Levels and Water Specs and defending them to FDA Lecture 9: Water System Investigation "How-To's" and Example Case Studies l Gathering and assessing existing data and symptoms l Considering user opinions l Investigation approach elements l Recognizing red herrings/false positives l Recognizing possible root causes l Water system contamination case studies l Parting kernels of water system wisdom Lecture 10: What USP Does and Doesn’t Say about PW, WFI, Pure Steam and Micro Issues l PW, WFI, Pure Steam micro specifications? l <1231> Starting water issues l <1231> Misunderstood issues clarified l <1231> Microbiological test issues clarified l <1231> Suggested micro test method l <1231> Micro Specifications l <1231> Alert and Action Levels and max’s l Recent/Upcoming USP water changes l Discrepancies between pharmacopeia’s l New water initiatives – need your input/feedback Click here to register for this seminar Who Will Benefit: l Microbiology Laboratory supervisors and analysts responsible for water sampling and testing l Quality Assurance personnel responsible for water system deviation management and change control l Regulatory and Compliance professionals responsible for FDA interactions l Process and Utility Engineers responsible for water system maintenance, repairs, troubleshooting, and excursion mitigation l Facility Engineers responsible for water system design or renovation l Validation personnel for water system qualification l Change Control personnel involved in water system changes and repairs l Production Managers involved with water system use for manufacturing and cleaning l Laboratory Managers and Supervisors responsible for lab water systems and other water sources It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. 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