ComplianceOnline
Course "The A to Z's of Microbial Control, Monitoring and Validation of Water Systems for Pharmaceuticals, Biologics, Medical Devices, Cosmetics, and Personal Care Products" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Course Description:

All facilities manufacturing pharmaceuticals, biologics, medical devices, cosmetics, and personal care products 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, it is site’s microbiologists who should understand the microorganisms in water systems and how best to monitor and control them. 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 lack of understanding of microbial control often leads to poor system designs, poor system sampling, poor system maintenance and poor sanitization practices, and as a result, ongoing microbial problems with the water.

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, since this training is for everyone involved with water systems, from the lab to utility room operations. The instructor will provide the necessary background needed to understand this very important subject matter. This understanding is essential for the proper design, validation, operation, monitoring, and maintenance of a high purity water system. Without this understanding, water system control and monitoring consists of a set of rules that often don’t work or result in erroneous monitoring data and can cause everything from very costly and unnecessary system downtime to patient injury and product recalls.

Seminar Fee Includes:

Lunch
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar



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 their water microbial test method.
  • Develop sound Alert and Action Levels and Water Specifications.
  • Prepare for a successful water system inspection by FDA or other regulators.



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 will benefit:

  • 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




Course Outline:

Day One (8:30 AM – 4:30 PM) Day Two (8:30 AM – 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

  1. Basics of Water System Biofilm Control by Design & Operation
    • 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
  2. Successful Water System Sanitization
    • Material and construction limitations
    • Continuous vs intermittent sanitization
    • The importance of biofilm removal
    • How sanitants work (or don’t work)
    • When to sanitize
    • Common causes for sanitization failures and troubleshooting sanitization problems
  3. Common Sense Water System Validation
    • Why validate a water system?
    • Basic ground rules for water systems before you validate them
    • Minimum validation expectations
    • Making changes to a validated water system
    • Special considerations for lab water systems
    • Are packaged waters a viable option?
  4. 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?
  5. 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
  1. 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
  2. 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
  3. 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
  4. Leadership in Mfg Contamination Control: The Microbiology Lab
    • How contamination is controlled
    • Why the microbiology lab should lead in contamination control
    • Routine contamination evaluation activities
    • Microbiological training
    • Root cause and impact investigations
    • Impediments to leadership
    • Doing the right thing
  5. Guarding Against Common Pharmaceutical 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




Meet Your Instructor

T.C. Soli
President of Soli Pharma Solutions, Inc

T.C. Soli, Ph.D., is President of Soli Pharma Solutions, Inc, with training, auditing, and troubleshooting expertise covering water systems, sterilization, aseptic processing, contamination control, and microbiological laboratories. He has over 36 years of combined pharmaceutical experience as a consultant and with operating companies (DSM Pharmaceuticals, Glaxo Wellcome, Burroughs Wellcome, and Pfizer). Dr. Soli's career-long water system and manufacturing contamination troubleshooting expertise, coupled with water-related USP, ISPE, PhRMA, and PDA committee and guide creation involvements, afford him practical knowledge about process and contamination control and mitigation; cleaning, sterilization, process, and microbiological testing validation; and all aspects of high purity water systems.

Dr. Soli is in his fourth 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 PDA and ISPE and is the author of USP’s Chapter <1231>.





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$1,299.00

Seminar One Registration (USD)

February 10-11, 2016, Dubai, UAE


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Local Attractions

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This amazing man-made island in the shape of a palm tree is considered the “8th Wonder of the World”. It houses a number of commercial properties and exclusive residential homes with their own private beaches.




The Dubai Mall is the world's largest shopping mall based on total area and sixth largest by gross leasable area. It offers a vast selection of shops with the latest in fashion, and an array of family activities. The Mall's Aquarium and Discovery Centre, officially earned the Guinness World Record for the world's "Largest Acrylic Panel".




The Dubai Fountain is a record-setting choreographed fountain system set on the 30-acre manmade Burj Khalifa Lake, at the center of the Downtown Dubai development in Dubai. Illuminated by 6,600 lights and 25 colored projectors, it is 275 m (902 ft) long and shoots water up to 500 feet into the air accompanied by a range of classical to contemporary Arabic and world music.




Visit the Dubai Museum to learn about the Dubai of yesteryear. Located in the Al Fahidi Fort in Bur Dubai, it is the oldest building in the city. The museum provides guests.




Dubai desert safari is a total entertainment package with adventure and fun elements that one should not be missed out at any cost. You can admire the scenic beauty of the golden sand dunes at the same time can have a slice of excitement as well.




These traditional Arabic-style souks offer a unique shopping experience in one of the oldest trading areas of the city. Located off the shores of the Dubai Creek in Deira, guests can take in the delightful sights and smells of these famous souks.




This creek has served as the life's blood of Dubai throughout its history, and as such offers much in the way of history and culture. In the evening guests can enjoy a delightful “Dhow” dinner cruise.






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