2-day In-person Seminar
The A to Z's of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems for Bio-pharma, Medical Devices and Cosmetics Industries
Time: 9:00 AM to 6:00 PM
Venue: Courtyard Arlington Crystal City/Reagan National Airport
**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.
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 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
Day 1 Schedule
Lecture 1. 3 hrs:
Controlling Water System Biofilm Through Design & Operation
- Microbial control - where and why it matters
- Biofilm basics and how it develops
- Biofilm impact on "active" surfaces
- Environmental resistances of biofilm
- Biofilm impact on purification unit operations and how to control it
- Good design practices to control biofilm
- Good maintenance practices to control biofilm
Lecture 2. 90 min:
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
- Common sanitization failure causes and troubleshooting sanitization problems
Lecture 3. 90 min:
Water System Validation by Logic Instead of Tradition
- Why validate a water system?
- Basic ground rules for water systems before you validate them
- Minimum validation expectations
- What happens after the honeymoon is over
- Making changes to a validated water system
- Special considerations for lab water systems
- Are packaged waters a viable option?
Lecture 4. 60 min:
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?
Lecture 5. 60 min:
Harmonizing vs Optimizing Water Microbial Testing for System Quality Control
- Water harmonization that has occurred
- Water Micro TM "Dis-Harmonization"
- Biofilm diversity in water systems
- The good and bad of Micro harmonization
- Where RMMs can fit in
Day 2 Schedule
Lecture 6. 90 min:
Microbial Enumeration Issues with High Purity Water Systems
- Biofilm enumeration issues (planktonic vs surface)
- Purpose of sampling and testing (PC vs QC)
- Traditional cultivative approach issues
- Validation of your test method
- Alternative RMM choices (advantages/disadvantages)
- Significance of water isolates
Lecture 7. 90 min:
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
Lecture 8. 90 min:
Water System Investigation "How-To's" and Example Case Studies
- Early information; user opinions
- Investigation approach elements
- Water system contamination case studies
- The Beige Puddle
- "TNTC"
- High TOC
- The Sloppy Lab
- Flanged PolyPro System
- The Stealthy Dead Leg
- Parting kernels of water system wisdom
Lecture 9. 90 min:
Myths of Water System Biofilm Control and Microbial Monitoring
- Why water myths develop
- Impact of c-GMPs
- Well-meaning but misguided precedents
- Scientifically unchallenged traditions
- Rule-hungry culture
- Water System Microbial Control Myths (Just a few)
- WFI from RO
- Turbulent Flow and Flow Rate
- Dead Leg Rules
- Smooth Surfaces
- Periodic Sanitization of 80°C Systems
- In-Line Sterilizing Filters
- Ozone as an Added Substance
- Water Microbial Testing Myths (Just a few)
- Referee Methods
- Thermophiles in Hot Systems
- R2A, 35°C, 5 days
- Test Filter Membrane Rating
- Compendial Action Levels
- USP <62> Tests for Specified Microorganisms in Purified Water
- TOC and Endotoxin as Microbial Count Correlates
Lecture 10. 60 min:
Avoiding Common Water System Inspection Pitfalls
- Initial Deficiencies Usually Lead to Others
- Design and Construction Issues
- Source Water Issues
- Sampling Issues
- Validation Issues
- Change Control Issues
- Procedure Issues
- Specification Issues
- Excursion Investigation Issues
- Training Issues
Want to register by P.O/Check?
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Following this just send us your purchase order by fax at 302 288 6884
In case you wish to register by using check
NetZealous LLC,
DBA GlobalCompliancePanel,
161 Mission Falls Lane,
Suite 216, Fremont, CA 94539, USA
Phone: 1800 447 9407
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Group participations
Get fabulous discounts by participating in groups of two or more.| No | Attendees | Discount |
|---|---|---|
| 1 | 2 Attendees | 10% off |
| 2 | 3 to 6 Attendees | 20% off |
| 3 | 7 to 10 Attendees | 25% off |
| 4 | 10+ Attendees | 30% off |
To avail the above group discounts, all the participants should register by making a single payment
Call our representative TODAY on 1800 447 9407 to have your seats confirmed!
Teri C. Soli
Principal Consultant, Soli Pharma SolutionsT.C. Soli is a Ph.D. Microbiologist and President of Soli Pharma Solutions, Inc. offering troubleshooting and training expertise covering water systems, sterilization, sterile and non-sterile manufacturing, microbiological laboratories, and microbial and beta-lactam contamination control. He has 39 years of pharmaceutical experience as a consultant and with operating companies including DSM Pharmaceuticals, Glaxo Wellcome, Burroughs Wellcome, and Pfizer.
His career-long water systems and contamination troubleshooting experience, coupled with water-related USP, ISPE, PhRMA, and PDA committee involvements, afford him practical knowledge about contamination control; cleaning, sterilization and process validation; and all aspects of high purity water systems.
He is in his 18th year on USP Expert Committees responsible for Pharmaceutical Water and has co-authored everything related to water in USP, including their informational chapter <1231> Water for Pharmaceutical Purposes. He previously served for 18 years on the PhRMA Water Quality Committee whose achievements included creating the Water Conductivity and TOC specifications used in USP Purified Water and Water for Injection and adopted world-wide.
Dr. Soli is a recognized global expert in contamination and biofilm control in the Biopharmaceutical, Medical Device, and Personal Care Product Industries and has authored numerous articles in Pharmacopeial Forum, Pharmaceutical Engineering, and Pharmaceutical Technology, as well as other publications and has authored chapters in many books and industry guides published by PDA and ISPE.