Pre-Sterilization Bioburden Failures and Causes

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1 Microrite, Inc. brings you this unique learning experience in Pre-Sterilization Bioburden Failures and Causes ; Part of Microrite s step-by-step webinar series. Pre-Sterilization Bioburden Failures and Causes Pre-sterilization bioburden is equally important in both medical device and drug manufacturing. Bioburden is monitored before sterilization. Working limits on contamination immediately before sterilization are established, which are related to the efficiency of the method to be used. Bioburden assay is performed on each batch for both aseptically filled product and terminally sterilized products. Where overkill sterilization parameters are set for terminally sterilized products, bioburden might be monitored only at suitable scheduled intervals. For parametric release systems, bioburden assays should be performed on each batch and considered as an in-process test. It is crucial to understand the causes of increase in pre-sterilization bioburden and the consequences of such increase. When? November 12 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 Microbiologists, Food, Facilities, Manufacturing and Training

2 November 12 th, 2013 Benefits to participants Facility design and flows may be the cause of increased pre-sterilization bioburden Components, parts, materials-bioburden unchecked Common causes of pre-sterilization bioburden spikes in medical devices Common causes of pre-sterilization bioburden increase in drugs Cleaning deficiencies and cross contamination Storage conditions may become the cause Who will be teaching? Ziva Abraham a known microbial contamination control expert and a seasoned mycologist has educated industry on fungal identification and investigating mold contaminations for over two decades. Her understanding of the origin and behavior of mold makes her a well-respected investigator for mold contaminations. She has over 25 years of academic, research, clinical and industrial experience in Microbiology, and Quality Assurance. She has trained personnel from various industries in microbiology techniques and methods. Ziva received her Master s Degree in Microbiology and has conducted graduate work on developing Microbial Insecticides. She has established clinical laboratory systems in Israel, and is involved in expanding Your Horizons, a program through the Math and Science Network to educate young girls about careers in science. She uses her hands on experience in varied fields to teach why assessing risk of microbial contamination should be in the forefront of any company that has products for human/veterinary use or to diagnose disease in humans and/or animals. Her experience in clinical laboratories has provided her with the framework to understand the effects of microbial contamination in products from a patient safety perspective. Microrite, Inc. is a consulting company based in San Jose, CA that helps Pharmaceutical, Medical Device, Biotechnology, and In Vitro Diagnostic companies in the areas of microbiological quality control for sterile and non-sterile manufacturing, quality assurance, and validation.

3 REGISTRATION FORM Pre-Sterilization Bioburden Failures and Causes 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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