Strategy for Investigating Microbial Contaminations

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Microrite, Inc. brings you this unique learning experience in Strategy for Investigating Microbial Contaminations; Part of Microrite s step-by-step webinar series. Strategy for Investigating Microbial Contaminations Often microbial contamination investigations are inconclusive. The reasons being; little understanding of system failures, monitoring and testing inconsistencies, test method deficiencies, media defects, misidentification or misinterpretation of contaminants and insufficient experience or training of investigators. Unless all these shortcomings of the investigative process are known or comprehended, it is difficult to develop a strategy or conduct a conclusive investigation. This brief but comprehensive training will help in performing in-depth investigations for microbial contaminations. When? September 12 th, 2017 1:30pm to 3:30pm Eastern Daylight Time Which industries does this webinar apply to? Pharmaceuticals, Biotechnology, and Medical Device Who will benefit? Quality Assurance, Quality Control, Microbiology, Regulatory Affairs, R&D, Facilities, Manufacturing, Clinical, Materials, Validation and Training Personnel

Benefits to the participants: September 12 th, 2017 Why environmental monitoring excursions occur, and what should be evaluated during investigations. Recurrent excursions point to system flaws and testing deficiencies. When water system failures occur it is not always the QC analyst s fault, there could be more to these failures than bad aseptic techniques. Compressed gas failures, though not common may point to inadequately maintained systems or testing flaws Contaminated in-process materials may be due to nature of raw materials, equipment or even the environment. Laboratory design, media quality, testing enclosures and the test method itself can be at fault for laboratory related failures Investigations cannot be haphazard, they need to be strategized and performed and documented sequentially Who will be teaching? Ziva Abraham is the President and Founder of Microrite, Inc., a California based consulting firm providing consulting and training services to pharmaceuticals, biotechnology, medical devices and in vitro diagnostics in the areas of quality assurance, quality control, microbiology, and validation. Ziva has over 25 years of academic, research, clinical and industrial experience in microbiology, and quality assurance. Ziva has received her Master s Degree in microbiology and has conducted research on developing microbial Insecticides using entomogenous bacteria and fungi. Her career also includes founding and managing clinical laboratories for Maccabi Medical in Israel. She has trained personnel from various industries in microbiology techniques and methods. She uses her extensive experience to teach why assessing risk of microbial contamination should be in the forefront of any company that has products for human/veterinary use. 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 focuses on helping companies with contamination control, microbiological quality control for sterile and nonsterile manufacturing, quality assurance, and validation.

REGISTRATION FORM Strategy for Investigating Microbial Contaminations Personal Information of One Registrant Last Name: Mr. Ms. Dr. First Name: Job Title: Organization: Mailing Address: Telephone: Email: Fee: (see fee structure below, all costs are per person) 1 attendee $225 2-5 attendees $180 (per person)(20% Discount) 6-10 attendees $153 (per person)(32% Discount) 11 or more attendees $135 (per person)(40% Discount) Method of Payment: Credit Card and Check payments only. Attendees can register and make payments on Microrite s website: www.microrite.com or complete this form and fax to 408-445-1236. Check payments must be cleared before the webinar date. If you have any questions regarding payment methods feel free to contact Microrite at 408-445-0507 or send your enquiry to webinars@microrite.com. Confirmation of registration will be sent via email. For credit card payment on website, a payment receipt will be considered as confirmation of registration. For credit card information faxed to Microrite an email confirmation will be sent with a copy of payment receipt. Please call 408-445-0507 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 email 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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