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Webinar on “Common Sense Water System Validation” from GlobalCompliancePanel

Education

(Free Press Release) GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a webinar on the topic, “Common Sense Water System Validation” on June 10. Teri C. Soli, President of Soli Pharma Solutions, Inc. will be the speaker at this session.

Webinar on “Common Sense Water System Validation” from GlobalCompliancePanel


      

Description:

Often, and wrongly, water system validation is carried out for the regulator’s sake, and seldom for its own sake. Most validations are done to satisfy the regulatory requirements, when a little more application and dedication can make the world a better place to live in, given the importance of water to human lives.

Water systems are unique and have their own validation requirements. More often than not, a one-size-fits-all approach is taken, which no doubt meets regulatory requirements, but falls woefully short at ensuring water quality and purity.

Attending this webinar will equip participants with the necessary skills and knowledge needed for putting a tailored water systems validation in place, taking into consideration each system’s unique requirements. It will teach them to take the maintenance practices and operational elements necessary for a proper water systems validation.

Teri will cover the following areas during this discussion:

o Why validate a water system?

o Basic ground rules for water systems before you validate them

o Micro Test Method “validation”

o Minimum validation expectations

o How to figure out what you should validate

o What happens after the honeymoon is over

o Is validation ever really over?

o Special considerations for lab water systems

o Are packaged waters a viable option?

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When: June 10, 10:00 AM PDT | 01:00 PM EDT

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By whom:

T.C. Soli is a Ph.D. Microbiologist and President of Soli Pharma Solutions, Inc. (www.solipharmasol.com), and since becoming a full time consultant, has served consumer products and FDA-regulated industries with training and troubleshooting expertise. The areas he has covered include water systems, sterilization, aseptic processing, microbiological and beta-lactam contamination control and microbiological laboratory operations. Soli has also served as a pharmaceutical expert witness in several "contamination" litigations.

 

Prior to full time consulting, he had 25 years of diverse "Big Pharma" operating company experience. During his 31+ year career, he has lectured extensively at conferences, authored numerous papers and has recently written several book chapters related to water system microbiology for USP, PDA and ISPE publications.

 

He is currently serving in his third five-year term on USP Expert Committees responsible for Pharmaceutical Waters through which he authored the complete rewrite of USP Chapter 1231, which many consider to be USP's "pharmaceutical water bible".

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For whom:

o Validation managers and personnel

o QA managers and other personnel involved in Change Control programs

o Utility operators and their managers involved in maintaining and sanitizing water systems

o QA managers and Regulatory Affairs personnel involved in defending water system operations and quality data to FDA and EMEA inspectors and outside auditors

o QA managers and personnel involved in investigations of excursions and preparing CAPAs

o QC managers and personnel involved in sampling, testing, and trending chem and micro data from water systems

o Consultants

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Duration: 90 minutes

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To enroll for this webinar, contact

This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Ph: 800-447-9407

 

Fax: 302-288-6884




Webinar on “Common Sense Water System Validation” from GlobalCompliancePanel

Source: Press Release

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