Full Day Virtual Seminar - Understanding Biofilm and Controlling It in Pharmaceutical Water Systems

Instructor: T.C Soli
Product ID: 701840
  • Duration: 6hrs

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556


Read Frequently Asked Questions

Why Should you Attend:
This interactive one-day course provides a thorough understanding of what makes water systems have microbial problems with proven solutions for microbial control, arguments for the micro lab being the spearhead of contamination investigations, step-by-step instructions for investigating and resolving microbial excursions in water and associated systems, and how to rationally validate the operation and microbial control in a water systems in a manner that will please FDA.

In short, if your job brings you in contact with any aspect of water system design, maintenance, trend monitoring, sampling, testing, sanitization, validation, root cause investigation and response to microbial excursions, or regulatory interactions, you cannot afford to miss this invaluable training as well as the tips, tricks, and kernels of wisdom that this all-day webinar will give you.

Learning Objectives:

  • Leveraging the pivotal capabilities of the Micro Lab in water system and other contamination investigations.
  • Understanding the impact of biofilm in a water system and how it can be controlled.
  • Rational approaches to validating water system operation and microbial control.
  • Successful strategies for water system deviation investigations with case studies.

6 hours of instruction, one hour lunch, and short breaks as they fit into the schedule.

Agenda (Times Eastern):

  • 10:00am (7am Pacific)-11:30 -- Module 1: The Microbiology Lab – Leader of Manufacturing Contamination Control (1:30)
  • 11:30-1:00pm -- Module 2: Biofilm and Its Impact on Water System Operations (1:30)
  • 1:00-2:00 Lunch hour
  • 2:00-3:30 -- Module 3: Rational Water System Validation (1:30)
  • 3:30-3:45 Afternoon break
  • 3:45-5:15 -- Module 4: Water System Contamination Investigations & Case Studies (1:30)
  • 5:15-5:30 Q&A


  • The Microbiology Lab – Leader of Manufacturing Contamination Control (1:30)
  • Interactive discussion that establishes the ideal roles for personnel involved in ongoing contamination control monitoring as well as responses when control measures have not worked.

    • 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
    • Observed contamination correlations
    • Doing the right thing
  • Biofilm and Its Impact on Water System Operations (1:30)
  • Interactive discussion that presents the basics about biofilm growth, the challenges biofilm creates to microbial control, and what measures can actually work and why.

    • Biofilm basics and how it develops
    • Environmental resistances of biofilm
    • Biofilm impact on “active” surfaces
    • Biofilm impact on purification unit operations
    • Good design practices to control biofilm
    • Good maintenance practices to control biofilm
    • Good sanitization practices and ongoing microbial control
  • Rational Water System Validation (1:30)
  • Interactive discussion of the fundamentals of water system validation with emphasis on what must be done in advance before validation commences as well as the typical content of each stage in the process, how lab water system validation can (and usually should be) different from manufacturing water systems, and whether using packaged waters is a reasonable alternative to a water system for a small volume user.

    • 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?
  • Water System Contamination Investigations & Case Studies (1:30)
  • Interactive discussion that describes an approach the author routinely uses in his consulting efforts to determine contamination root causes, with emphasis on which “stones to turn over” during your investigations to find the true cause(s) of the contamination events. Entertaining case studies will demonstrate the principles used and the all-day webinar will close with a few true-isms that will be invaluable to remember in future water system involvements.

    • 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

    Who Will Benefit:

    • Engineers responsible for water system design and fabrication
    • Maintenance personnel responsible for water system maintenance and sanitization
    • Microbiological personnel involved in collecting and testing water system samples
    • Validation personnel involved in writing and executing water system validation protocols
    • Quality Assurance professionals involved in deviation investigations and oversight/approval of all other water system activities as well as those involved in defending water system issues to regulatory investigators who may or may not be water experts themselves
    • Regulatory Affairs professionals involved in describing water and water systems in regulatory filings and also those involved with regulatory inspections
    • Managers and supervisors of all these disciplines who need to understand what makes water systems unique design, control, monitoring, validation, and investigative challenges

    Instructor Profile:
    Dr. 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 ISPE.

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