The A to Z's of Microbial Control, Monitoring and Validation of Water Systems for Pharmaceuticals, Biologics, Medical Devices, Cosmetics, and Personal Care Products

	Course "The A to Z’s of Microbial Control, Monitoring and validation 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.

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.

Register for New Jersey May 24-25, 2012 One Registration - New Jersey - $1199 Register Now !

Cancellations and Substitutions Written cancellations received at least 15 calendar days prior to the start date of the event will receive a refund — less a $150 administration fee. No cancellations will be accepted — nor refunds issued — within 15 calendar days from the start date of the event. A credit for the amount paid may be transferred to any future ComplianceOnline event. Substitutions may be made at any time. No-shows will be charged the full amount. In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Hurry. Register early because space is limited. Your tuition fee includes the workshop, all course materials, and lunch.

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
• Validate your water microbial test method
• Develop sound Alert and Action Levels and Water Specifications
• Defend your test method, in-process control levels and specifications to FDA

Areas Covered:

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 34. The course instructor is the primary author of that revised chapter.

Key topics covered will include:

• The “real” story behind some common water system design and control myths
• Biofilm properties, resistances, susceptibilities and examples
• Water system sanitization to control biofilm
• Water system microbial enumeration issues
  • USP’s view on sampling and microbial enumeration
  • Microbial enumeration options/advantages/disadvantages
  • How to chose the best microbial enumeration method and “validate” it
• Water System Validation and Change Control
• Improving outcomes and reducing the frequency of excursion investigations
• How to perform successful Water System excursion investigations
• What USP actually says about all this

Course Modules & Content Details:

What Makes Water Systems Have Microbial Quality Problems Understand biofilm basics and how it develops Understand the impact of biofilm on the commonly used purification unit operations Understand how various commonly used microbial control strategies work (or don’t work) to control biofilm development Understand the how, where, and why of microbial monitoring, action levels, etc. Debunk a few water system myths Get answers to your own water system questions Successful Sanitization Approaches for Trouble-Free Water Quality Material and construction limitations Continuous vs intermittent sanitization The importance of biofilm removal How sanitants work (or don’t work) When to sanitize Troubleshooting sanitization problems Water System Validation by Logic Instead of Tradition Why validate a water system? Basic ground rules for water systems before you validate them Micro Test Method “validation” Minimum validation expectations How to figure out what you should validate What happens after the honeymoon is over Is validation ever really over? Special considerations for lab water systems Are packaged waters a viable option? Implementing Changes to a Validated System Purpose of a Change Control program – a help, not a hindrance When is a change major vs minor, requiring full vs limited re-qualification? What about water use during re-qualifications? FDA validation expectations Reliance on logic and common sense and the disservice of precedent and paradigms Additional useful tips Reducing Water Microbial Excursions & Improving Investigations What are excursions? Water system dilemma: process control or quality control (utility or raw material), or both Intended roles of Alert/Action Levels and Specifications Investigation, necessary and often fruitless Excursion responses and impact Criticality of valves, hoses, & outlet flushing Diagnosing the source of the problem Minimizing unnecessary excursion responses through best practices

Understanding and Controlling Endotoxin Where 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? Harmonizing vs Optimizing Water Microbial Testing for System Quality Control Water harmonization that has occurred Water Micro TM “Dis-Harmonization” A little about Biofilm Biofilm diversity in water systems Micro TM options and evaluation protocol The good and bad of Micro harmonization Where RMMs can fit in Parting wisdom Microbial Enumeration Issues with High Purity Water Systems Biofilm enumeration issues (planktonic vs surface) Traditional cultivative approach issues Validation of your test method Alternative TM choices (advantages/disadvantages) Significance of water isolates Sampling issues Establishing Alert/Action Levels and Water Specs and defending them to FDA Water System Investigation "How-To's" and Example Case Studies Gathering and assessing existing data and symptoms Considering user opinions Investigation approach elements Recognizing red herrings/false positives Recognizing possible root causes Water system contamination case studies Parting kernels of water system wisdom What USP Does and Doesn’t Say about PW, WFI, Pure Steam and Micro Issues PW, WFI, Pure Steam micro specifications? <1231> Starting water issues <1231> Misunderstood issues clarified <1231> Microbiological test issues clarified <1231> Suggested micro test method <1231> Micro Specifications <1231> Alert and Action Levels and max’s Recent/Upcoming USP water changes Discrepancies between pharmacopeias New water initiatives – need your input/feedback

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, troubleshooting, and excursion mitigation
• Facility Engineers responsible for water system design or renovation
• Validation personnel for water system qualification

Conference Details:

Location 1:

New Jersey (venue to be announced shortly)

Thursday, May 24 and Friday, May 25, 2012, 9 AM to 5 PM EDT

Actual Price: $2299 per registration (Register today to get early bird discounts).

Register for New Jersey May 24-25, 2012 One Registration - New Jersey - $1199 Register Now !

Cancellations and Substitutions Written cancellations received at least 15 calendar days prior to the start date of the event will receive a refund — less a $150 administration fee. No cancellations will be accepted — nor refunds issued — within 15 calendar days from the start date of the event. A credit for the amount paid may be transferred to any future ComplianceOnline event. Substitutions may be made at any time. No-shows will be charged the full amount. In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Hurry. Register early because space is limited. Your tuition fee includes the workshop, all course materials, and lunch.

Meet Your Instructor

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.

He is in his third 5 year term on USP Expert Committees responsible for Pharmaceutical Water, previously served 5 years on the Advisory Panel to the USP Microbiology Subcommittee, and helped develop the Water Conductivity and TOC specifications used by USP and adopted world-wide. He has authored many articles and chapters in books and industry guides published by USP, PDA and ISP.