Key Elements of a Microbial Contamination Control Policy Why and how to write a policy for Microbial Contamination Control

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1 Microrite, Inc. brings you this unique learning experience Key Elements of a Microbial Contamination Control Policy; Part of Microrite s step-by-step webinar series. Key Elements of a Microbial Contamination Control Policy Microbial contamination Control should never be an afterthought! Microbial contamination control should start with facility design and end with the product s shelf life. Contamination of a product can occur due to the environment, equipment, container closures, process and personnel. If not thought out using a good scientific rationale and documented, contamination control strategies can be lost in day to day operations. This 2 hour webinar will teach you how to think aloud and how to document each step to create awareness about microbial contamination at various levels of manufacturing. Also, this policy can become a living document for proactive actions instead of reactive chaos. When? July 18 th, :30pm to 3:30pm Eastern Standard Time Which industries does this conference apply to? Pharmaceuticals, Biotechnology, Medical Device, and In Vitro Diagnostics Who will benefit? Quality Assurance, Quality Control Microbiologists, Facilities, Materials Management, Validation, Engineering, Purchasing, and Training

2 18 July, 2013 Benefits to participants Outlining contamination control strategies for: Facilities o Design criteria, flows, maintenance, cleaning, and strategy for monitoring Equipment o Process equipment cleaning and sterilization strategy o Maintenance and cleaning of cold-rooms, incubators, refrigerators and equipment that can promote or harbor microbial contaminations o Process aids, cleaning Utilities o Maintenance, Sanitization and monitoring strategies Raw materials, Formulations, API, In-process materials o Rationale behind specifications and testing Final product testing o How microbial specifications are derived and testing strategy Microbial trends o What will be trended and how trends be analyzed 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 Key Elements of a Microbial Contamination Control Policy 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.

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