Investigating Microbial Data Deviations

Transcription

1 Microrite, Inc. brings you this unique learning experience in Investigating Microbial Data Deviations; Part of Microrite s step-by-step webinar series. Investigating Microbial Data Deviations Since the issuance of the Barr Decision there has been an increased regulatory focus on out-of-specification and deviations/investigations in the laboratory. For microbiologists, this led to the concept of microbial data deviations. This talk discusses some of the concepts associated with microbiology laboratory investigations and how these investigations lead to conclusions. When? April 25 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, Facilities, Manufacturing and Quality Control Microbiologists

2 25 April, 2013 This 2 hour course will include: What is a Microbial Data Deviation, and how is it like an out-of-specification? The initial phase of the investigation: Is the data valid? If valid, what should be considered in the investigation? How do you generate a product impact analysis? Making conclusions for the report Who will be teaching? Jeanne Moldenhauer, Excellent Pharma Consulting has more than 25 years experience in the pharmaceutical industry. She chairs the Environmental Monitoring/Microbiology Interest Group of PDA, serves on the Scientific Advisory Board of PDA, founded the Rapid Microbiology User s Group, and is a member of ASQ and RAPS. She is the author of Steam Sterilization: A Practitioner s Guide, Laboratory Validation: A Practitioner s Guide, Environmental Monitoring: A Comprehensive Handbook, System s Based Inspections for Pharmaceutical Manufacturers, co-author of Biological Indicators, and numerous other publications.

3 REGISTRATION FORM Investigating Microbial Data Deviations 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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