Pharmaceutical Water System Sampling The Why s, Where s, and How s of Doing It Right

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Bethanie Shaw
6 years ago
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Microrite, Inc. brings you this unique learning experience in Pharmaceutical Water System Sampling; Part of Microrite s step-by-step webinar series.

1 Microrite, Inc. brings you this unique learning experience in Pharmaceutical Water System Sampling; Part of Microrite s step-by-step webinar series. Pharmaceutical Water System Sampling Problematic removal of pristine water from a pharmaceutical or other high purity water system, for use in manufacturing, cleaning or for sampling, is likely responsible for as much as 90% of all water system deviations. Done properly, it can lead to greatly reduced product or process contamination, improved water system control and avoidance of time-consuming and frustratingly inconclusive problem investigations. At the heart of the problem is a fundamental misunderstanding of the purposes and practice of sampling and testing, and how to most effectively use the resulting data to improve manufacturing s water use practices and maintain water system control before problems arise from biofilm-related contamination. This webinar will correct these misunderstandings and explain practical best practices for outlet use and sampling to reflect the true water quality, including grab samples and on-line testing, that could pave the way to adoption of dramatic resource saving Real-Time Release approaches for BOTH chemistry and microbiological attributes of these waters. When? March 18 th, :30pm to 3:30pm Eastern Standard Time Which industries does this conference apply to? Industries that will benefit from this training are: Pharmaceuticals, Biotechnology, Medical Device, In Vitro Diagnostics, Food and Cosmetics Who will benefit? Quality Assurance, Quality Control Microbiologists, Engineering, Facilities, Manufacturing, Validation, Regulatory Affairs and Training personnel.

2 18 March, 2013 This 2 hour course will include: Importance of proper sampling Process or Raw Material? Uses of water sampling data PC or QC? Data use impact on sampling locations for o Chemical testing o Endotoxin testing o Microbial testing Data use impact on microbial sampling techniques Sampling plan options Test method options Practicality of real time release Who will be teaching? Dr. Teri C. ("T.C.") Soli is President and Principal Consultant for Soli Pharma Solutions, Inc. His expertise is focused in water systems, sterilization and aseptic processing, contamination control, and microbiological laboratories. He has 25 years of diverse pharmaceutical operating company experience with the DSM/Catalytica/GlaxoWellcome/BurroughsWellcome companies and Pfizer. His experience includes Chemical and Microbiological Analytical Development, Validation and Compliance, Troubleshooting, QC/QA Operations, Aseptic Process Validation, Regulatory Affairs, Project Management, Business Development, and Information Technology. Dr. Soli s career-long water systems involvements and participation with water-related industry committees, plus extensive lecturing experience afford him extensive knowledge about water and high purity water systems. He is in his second 5 year term of membership on the USP Pharmaceutical Waters Expert Committee and previously served 5 years on the Advisory Panel to the USP Microbiology Subcommittee as well as 16 years with the PhRMA Water Quality Committee.

3 REGISTRATION FORM Pharmaceutical Water System Sampling Personal Information of One Registrant Last Name: Mr. Ms. Dr. First Name: Title: Organization: Mailing Address: Telephone: Fee: (see fee structure below) 1 attendee $ attendees $180 (per attendee)(20% Discount) 6-10 attendees $153 (per attendee)(32% Discount) attendees $135 (per attendee)(40% Discount) Method of Payment: Credit Card and Check payments only. Attendees can register and make payments on Microrite s website- or complete this form and fax to Check payments must be cleared before the webinar date. If you have any questions regarding payment methods feel free to contact Microrite at or send your enquiry to info@microrite.com. Confirmation of registration will be sent via . For credit card payment on website, a payment receipt will be considered as confirmation of registration. For credit card information faxed to Microrite an confirmation will be sent with a copy of payment receipt. Please call in due time if confirmation is not received after payment.

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5 Choose One (Place X) VISA Master Card American Express Card Holder s Name Address of Card Holder: Enter firm address for corporate card or personal address for personal card Street: City: Zip Code: Country: Contact Ph No & Card Number: Expiration(Month/Year): Name on Card: Amount (US Dollars): Signature: Name of Attendee(s) Referred by: Kindly note the name of the company or person that referred you to this workshop. We would like to thank them.

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