Pharmacopoeial Antimicrobial Effectiveness Testing

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1 Microrite, Inc. brings you this unique learning experience in ; Part of Microrite s step-by-step webinar series. The purpose of the is to establish and verify the effectiveness of antimicrobial preservative systems that are added to non-sterile dosage forms and to sterile multi-dose containers. These systems are designed to inhibit the growth of microorganisms that might have been introduced during manufacturing or that are introduced in sterile multi=dose containers by the repeating withdrawal of product. The procedure and the criteria for effectiveness are set forth in USP General Chapter <51>Antimicrobial Effectiveness Testing. Harmonization of the procedure among the USP, JP, and the European Pharmacopoeia has been achieved, but some of the criteria for effectiveness are not harmonized. When? October 30 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, and In Vitro Diagnostics Who will benefit? Quality Assurance, Quality Control Microbiologists, and Training

2 Benefits to the participants: 30 October, 2012 Understand why non-sterile products and sterile products in multi-dose containers must contain antimicrobial preservatives Have an understanding of the various antimicrobial preservative systems available for use in pharmaceutical products In- depth review of the testing procedure Common errors made when testing and what to do to avoid them How to validate the test and verification of the antimicrobial preservative system efficacy during shelflife. Regulatory issues. Who will be teaching? Dr. Roger Dabbah, Principal Consultant for Tri-Intersect Solutions founded in 2006 following an extensive career at the US Pharmacopeia that he joined in Dr Dabbah was Director of the Complex Actives Division responsible for a number of expert Committees composed of governments, academic, and industrial scientists dealing with microbiological testing, sterilization systems, toxicology, devices and diagnostics, biological including biotechnology derived products, gene and cell therapy, biocompatibility, alternatives to animal testing, parenterals, and water for pharmaceutical purposes. He was also instrumental in the successful harmonization initiatives for microbiological testing and biotechnology-derived products with the Pharmacopoeia of Europe and Japan. Dr Dabbah is a well-known speaker on microbiological topics and has written numerous papers, articles, and chapters in books on microbiological control of pharmaceutical and biotech products. He is also on the editorial Board of Pharmaceutical Technology and Bioprocess International.

3 REGISTRATION FORM 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.