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.
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.
- Defend their test method, in-process control levels and specifications to FDA.
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
- Registration Process: 8:30 AM – 9:00 AM
- Session Start Time: 9:00 AM
- 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
- 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
- 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?
- 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
- 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
- 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
- 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
- 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
- USP Chapter <1231> : What USP Says about PW, WFI, Pure Steam & 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
- 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
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 34 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 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 PDA and ISPE and is the author of USP’s Chapter <1231>.
Register Now
Online using Credit card
Get the Invitation
Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
Call here to register +1-888-717-2436 or email at [email protected]
Other Registration Option
- Download the Order Form
- Fill this form with attendee details & payment details
- Fax it to +1-650-362-2367, or
- Email it to [email protected]
Payment Mode
ComplianceOnline (MetricStream, Inc),
6201 America Center Drive Suite 240
San Jose, CA 95002
USA
Register / Pay by Wire Transfer
Please contact us at +1-888-717-2436 to get details of wire transfer option.Terms & Conditions to Register for the Seminar/Conference/Event
Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ [email protected]
Payment:
Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).
Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.
Substitutions may be made at any time. No-shows will be charged the full amount.
We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.
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.
Attendance confirmation and documents to carry to the seminar venue:
After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.
Conference photograph / video:
By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.
Offers:
We are pleased to offer several exhibitor, sponsorship and media partnership options designed to maximize your company's exposure and networking opportunities before, during and after the event.
Benefits of becoming a Sponsor/Exhibitor/Media Partner:
- Logo on website, marketing email, branding materials & the registration booth
- Exhibit Space
- Free event pass
- Speaking opportunity
- Social media campaign
For more details and other sponsorship options at this event, please contact Event Manager: [email protected] or call: +1-650-238-9656
Media Partner:
Local Attractions of San Francisco, CA
Think Escape Party Bus
San Francisco Bay Area
Board a luxurious Think Escape party bus or limo and be whisked away to San Francisco's hottest nightclubs where VIP treatment brings all party bus guests to the front of the line. Planning the perfect night on the town is easy with Think Escape's fleet of luxury buses and extended vehicles, each with different amenities for socializing and transport. Think Escape's Bay Area party bus rentals include free entry into selected exclusive nightclubs, professional hostess and chauffer, in-vehicle coolers stocked with amenities for a perfect night of partying.
Alcatraz Lunch Cruise
The Alcatraz Lunch Cruise is a luxurious way to get to see some of San Francisco’s favorite sights. A gourmet lunch buffet features options like asiago Caesar salad, bay shrimp salad, roasted chicken, garlic-herb roasted new potatoes and more. While guests enjoy lunch, they can take in views of San Francisco Bay’s flora and fauna, Angel Island and Alcatraz, and a live narration explores the history of Alcatraz. Please note that this tour doesn’t stop on Alcatraz Island.
Luxury Catamaran Sailing Cruise
A relaxing way to explore the San Francisco Bay is with the Luxury Catamaran Sailing Cruise. A drink bar and snacks are available for travelers’ enjoyment as they travel under the Golden Gate Bridge, around Alcatraz Island and even past a colony of sea lions. This is a peaceful San Francisco cruise option for families, and children under 5 ride for free.
City Kayak
City Kayak, located on San Francisco's Embarcadero close to the San Francisco Giant's ATT Park, offers a great way to experience San Francisco from Bay level, a point of view and a unique experience you'll not soon forget.
Think Escape Casino Tour
San Francisco Bay Area
San Franciscans may be familiar with Think Escape's party buses that shuttle the late-night crowds to and from various city nightclubs, but the Cache Creek Casino Escape is a little-known gem among Bay Area destinations. With personal charter service on the luxurious Fantasy Limo Bus to Cache Creek Casino and Resort, the Cache Creek Casino Escape tour is a smart choice for San Franciscans looking for a little gaming fun or planning a large group activity
