2012 - The A to Z’s of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems - US Seminar 2012 at Pennsylvania

Overview: 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.
Areas Covered in the Session:
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 and troubleshooting, with case study examples
What USP actually says about all this
Course Modules & Content Details:
Day 1, April 19, 2012
Lecture 1: 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
Lecture 2: 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
Lecture 3: 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?
Lecture 4: 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
Lecture 5: 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
Day 2, April 20, 2012
Lecture 6: 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 7: 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
Lecture 8: 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
Lecture 9: 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
Lecture 10: 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 pharmacopeia’s
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, 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
Contact Information:
Event Coordinator
Toll free: 800-425-9409
Fax: 302-288-6884
Email: support-AT-globalcompliancepanel.com
http://www.globalcompliancepanel.com
Price: $1,495.00
GlobalCompliancePanel
1000 N West Street, Suite 1200,
Wilmington, DE 19801, USA