In-House Microbial Isolates in Compendial Testing: Regulatory Requirements

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1 Microrite, Inc. brings you this unique learning experience in In-House Microbial Isolates in Compendial Testing: Regulatory Requirements; Part of Microrite s step-by-step webinar series. In-House Microbial Isolates in Compendial Testing: Regulatory Requirements Two decades ago, with its issuance of its Guide to Inspections of Microbiological Pharmaceutical Quality Control Laboratories, the FDA made clear its expectation that in-house microbial isolates be incorporated into media growth promotion testing. Since then, enforcement action has reflected this requirement, and has expanded to disinfectant efficacy testing. Prominent industry leaders have advocated the use of these wild type organisms. This webinar will provide a regulatory background and highlight industry leader insights. Importantly, it will provide guidance for selecting the appropriate isolates to include in compendial testing in order to meet current regulatory requirements. When? September 26 th, :30pm to 3:30pm Eastern Standard Time Which industries does this webinar apply to? Pharmaceuticals, Biotechnology, Medical Device, Vitamins, Cosmetics and In Vitro Diagnostics Who will benefit? Quality Assurance, Quality Control Microbiologists, Regulatory Affairs, and Training

2 Benefits to participants September 26 th 2013 Current Industry Debate Over the Use of In-House Isolates in Compendial Testing Compliance Deficiencies Disinfectant Efficacy Testing Media Growth Promotion Testing Test Method Suitability/Qualification Rapid Microbiological Methods Selection of In-House Isolates for Use in Compendial Testing Who will be teaching? Robert Westney is President and Director of Quality and Operations for Cryologics, Inc., which specializes in converting in-house microbial isolates into formats suitable for use in compendial testing. He is also Principal Consultant for Westney & Associates Consulting, LLC. He has more than 25 years of experience in the GMP industry, including Quality Control Microbiology, Quality Assurance and Regulatory Affairs. He holds a Master of Science degree from Temple University in Quality Assurance/Regulatory Affairs. He is Regulatory Affairs Certified (RAC), and is a Certified Manager of Quality/Organizational Excellence (CMQ/OE). He is a member of the Pharmaceutical Microbiology Forum (PMF), the American Society for Microbiology (ASM), the Parenteral Drug Association (PDA), the Regulatory Affairs Professional Society (RAPS), and a Senior Member of the American Society for Quality (ASQ).

3 REGISTRATION FORM In-House Microbial Isolates in Compendial Testing: Regulatory Requirements Personal Information of One Registrant Last Name: Mr. Ms. Dr. First Name: Job 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. Webinar cancellation must be received 3 business days prior to the webinar less a 10% service fee, cancellation requests will be accepted via only. All refund requests must be made by the organizations primary contact or credit card holder. Refunds will be credited to the original credit card used to purchase the webinar.

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