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Microbial Control, Monitoring, Validation and Troubleshooting 2017

Start Date:
Thursday, 14 September, 2017
End Date:
Friday, 15 September, 2017 6:00pm
Dermatology, Gastroenterology, Immunology, Pain Management, Endocrinology, Infectious Disease, Gynecology, Radiology

Course "The A to Z's of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: 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. 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 testingQuality Assurance personnel responsible for water system deviation management and change controlRegulatory and Compliance professionals responsible for FDA interactionsProcess and Utility Engineers responsible for water system maintenance, repairs, troubleshooting, and excursion mitigationFacility Engineers responsible for water system design or renovationValidation personnel for water system qualificationChange Control personnel involved in water system changes and repairsProduction Managers involved with water system use for manufacturing and cleaningLaboratory Managers and Supervisors responsible for lab water systems and other water sources Agenda: Day 1 Schedule Lecture 1:What Makes Water Systems Have Microbial Quality ProblemsUnderstand biofilm basics and how it developsUnderstand the impact of biofilm on the commonly used purification unit operationsUnderstand how various commonly used microbial control strategies work (or don't work) to control biofilm developmentUnderstand the how, where, and why of microbial monitoring, action levels, etc.Debunk a few water system mythsGet answers to your own water system questionsLecture 2:Successful Sanitization Approaches for Trouble-Free Water QualityMaterial and construction limitationsContinuous vs intermittent sanitizationThe importance of biofilm removalHow sanitants work (or don't work)When to sanitizeTroubleshooting sanitization problemsLecture 3:Water System Validation by Logic Instead of TraditionWhy validate a water system?Basic ground rules for water systems before you validate themMicro Test Method "validation"Minimum validation expectationsHow to figure out what you should validateWhat happens after the honeymoon is overIs validation ever really over?Special considerations for lab water systemsAre packaged waters a viable option?Lecture 4:Implementing Changes to a Validated SystemPurpose of a Change Control program - a help, not a hindranceWhen is a change major vs minor, requiring full vs limited re-qualification?What about water use during re-qualifications?FDA validation expectationsReliance on logic and common sense and the disservice of precedent and paradigmsAdditional useful tipsLecture 5:Reducing Water Microbial Excursions & Improving InvestigationsWhat are excursions?Water system dilemma: process control or quality control (utility or raw material), or bothIntended roles of Alert/Action Levels and SpecificationsInvestigation, necessary and often fruitlessExcursion responses and impactCriticality of valves, hoses, & outlet flushingDiagnosing the source of the problemMinimizing unnecessary excursion responses through best practicesDay 2 ScheduleLecture 6:Understanding and Controlling EndotoxinWhere does endotoxin come from?What are the properties of endotoxin?How do you get rid of it?How do you detect it?What assay controls are used?What are the endotoxin specs for water?How do you control it?Lecture 7:Harmonizing vs Optimizing Water Microbial Testing for System Quality ControlWater harmonization that has occurredWater Micro TM "Dis-Harmonization"A little about BiofilmBiofilm diversity in water systemsMicro TM options and evaluation protocolThe good and bad of Micro harmonizationWhere RMMs can fit inParting wisdomLecture 8:Microbial Enumeration Issues with High Purity Water SystemsMicrobial Enumeration Issues with High Purity Water SystemsBiofilm enumeration issues (planktonic vs surface)Traditional cultivative approach issuesValidation of your test methodAlternative TM choices (advantages/disadvantages)Significance of water isolatesSampling issuesEstablishing Alert/Action Levels and Water Specs and defending them to FDALecture 9:Water System Investigation "How-To's" and Example Case StudiesGathering and assessing existing data and symptomsConsidering user opinionsInvestigation approach elementsRecognizing red herrings/false positivesRecognizing possible root causesWater system contamination case studiesParting kernels of water system wisdomLecture 10:What USP Does and Doesn't Say about PW, WFI, Pure Steam and Micro IssuesPW, WFI, Pure Steam micro specifications? Starting water issues Misunderstood issues clarified Microbiological test issues clarified Suggested micro test method Micro Specifications Alert and Action Levels and max'sRecent/Upcoming USP water changesDiscrepancies between pharmacopeia's SpeakerTeri C.

SoliPrincipal Consultant, Soli Pharma Solutions 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 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. Location: Shanghai, China Date: September 14th & 15th, 2017 and Time: 9:00 AM to 6:00 PMVenue: WILL BE ANNOUNCED SOON, Shanghai, China 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: $1,895.00Register for 5 attendees Price: $5,085.00 $8,475.00 You Save: $3,390.00 (40%)* Sponsorship Program benefits for "Quality Assurance Auditing for FDA Regulated Industry" seminar At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO's of various designations.

Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry. As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory-related industries and become known among these elite executives and subject matter experts.

Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants. For More Information- Normal 0 false false false EN-US X-NONE X-NONE /* Style Definitions */ table.MsoNormalTable{mso-style-name:"Table Normal";mso-tstyle-rowband-size:0;mso-tstyle-colband-size:0;mso-style-noshow:yes;mso-style-priority:99;mso-style-parent:"";mso-padding-alt:0in 5.4pt 0in 5.4pt;mso-para-margin-top:0in;mso-para-margin-right:0in;mso-para-margin-bottom:10.0pt;mso-para-margin-left:0in;line-height:115%;mso-pagination:widow-orphan;font-size:11.0pt;font-family:"Calibri","sans-serif";mso-ascii-font-family:Calibri;mso-ascii-theme-font:minor-latin;mso-hansi-font-family:Calibri;mso-hansi-theme-font:minor-latin;}



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Conference organized by NetZealous DBA as GlobalCompliancePanel

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