Microbial Detection Methods and Their Limitations

Transcription

1 Microrite, Inc. brings you this unique learning experience in Microbial Detection Methods and Their Limitations; Part of Microrite s step-by-step webinar series. Microbial Detection Methods and Their Limitations There are some very real flawed expectations concerning microbiological tests. It is important to understand the limitations of the tests so that data is not over-interpreted, and the wrong conclusions are not derived. Professional microbiologists understand these limitations, but explaining them to a novice may be difficult. That makes this topic important in order to bridge the knowledge gap between the microbiology lab and their internal and external customers. When? September 16 th, :30pm to 3:30pm Eastern Standard Time Which industries does this webinar apply to? Pharmaceuticals, Biotechnology, Medical Device, Food and In Vitro Diagnostics Who will benefit? Quality Assurance, Quality Control, Microbiology, Manufacturing, and Training

2 September 16 th, 2014 Points to be covered: Variables that affect microbial testing Nature of the sample and impact on microbial recovery Sterility test limitations Microbiological Examination Enumeration tests Microbiological Examination Tests for specified microorganisms Endotoxin Detection Methods Limitations Environmental Monitoring Data Who will be teaching? Robert Guardino is the founder and principal microbiology consultant for MicroGuard Consulting, LLC, a company that exists to assist the Pharmaceutical and Biotechnology industries with microbiological compliance and concerns. His most recent experience is in the fields of generic oral solid dosage forms, topical drugs, animal oral and topical formulations and positron-emission tomography (PET) injectable products. Prior to this role Mr. Guardino served as the Director of the Microbiology Lab for a pharmaceutical development company where he oversaw a full-service contract Microbiology Laboratory in support of the Pharmaceutical and Biotechnology industries. In this role Mr. Guardino gained experience with many different pharmaceutical, biotechnology and medical device product formats. After earning a Master of Science Degree from the University of Buffalo in Medical Technology with a concentration in Microbiology, he performed research in Microbiology and Biotechnology for several years and supervised an industrial microbiology lab for five years. Mr. Guardino has also held positions as a product development / quality assurance supervisor for rapid microbial diagnostic products and as a principal scientist during the development of PCR-based diagnostic products for a JNJ Company. His Quality System / Good Manufacturing Practice Regulations experience span 30 years. Areas of expertise include microbial contamination and control; microbial specifications for non-sterile and sterile dosage forms; drug substance, excipient, in-process and finished product microbiological method suitability and testing requirements; release and stability requirements and testing; down-stream / purification process contamination and control strategies for biotechnology products; disinfectant qualification; water system and environmental validation. He has presented seminars and workshops domestically and internationally on theory of microbiology testing.

3 REGISTRATION FORM Microbial Detection Methods and Their Limitations Personal Information of One Registrant Last Name: Mr. Ms. Dr. First Name: Job Title: Organization: Mailing Address: Telephone: Fee: (see fee structure below, all costs are per attendee) 1 attendee $ attendees $180 (per attendee)(20% Discount) 6-10 attendees $153 (per attendee)(32% Discount) 11 or more 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 webinars@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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