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

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Category seminar Pennsylvania,A to Z’s of Microbial Control,Troubleshooting of Pharmaceutical Water Systems,Trouble Free Water Quality,Validated System,Controlling Endotoxin

Deadline: April 19, 2012 | Date: April 19, 2012-April 20, 2012

Venue/Country: Pennsylvania, Courtyard by Marriott Philadelphia D, U.S.A

Updated: 2012-03-14 19:44:53 (GMT+9)

Call For Papers - CFP

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: supportglobalcompliancepanel.com

http://www.globalcompliancepanel.com

Price: $1,495.00

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