Microrite, Inc. brings you this unique learning experience in Investigating Non-Sterile Product Bioburden Failures ; Part of Microrite s step-by-step webinar series. Investigating Non-Sterile Product Bioburden Failures Non-sterile pharmaceutical products, cosmetics, plant based products, microbiologically controlled in-vitro diagnostics and some drug device combinational products all face the same dilemma; what level of microbial control is required in facilities, process, packaging to ensure that the bioburden limits for the product are met? Bioburden failures of non-sterile product are partly due to no definitive guidance, but mostly due to inadequate microbial control. In this webinar the common causes of bioburden failures will be outlined and investigating strategies will be discussed. When? October 15 th, 2013 1:30pm to 3:30pm Eastern Standard Time Which industries does this webinar apply to? Pharmaceuticals, Biotechnology, Medical Device, and In Vitro Diagnostics Who will benefit? Quality Assurance, Quality Control Microbiologists, Regulatory Affairs, Facilities, Manufacturing, and Training
October 15 th, 2013 Benefits to participants Outlining the causes and investigation strategy for bioburden failures in non-sterile products : Bioburden Test Results o One time occurrence or failure trend o Tested per Microbial limits test? o Objectionables identified- review how the test was validated o Membrane filtration common causes of failures Equipment o Process equipment cleaning and sterilization strategy investigation Process o Process validated o Bulk in cold storage before fill o Method of microbial control in bulk and product Stability Testing Failures o Stability ever failed? Raw materials, Formulations, API, In-process materials o Rationale behind testing or accepting per vendor C of A Microbial Trends o Microbial trends in environmental monitoring, in-process testing and utilities 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.
REGISTRATION FORM Investigating Non-Sterile Product Bioburden Failures Personal Information of One Registrant Last Name: Mr. Ms. Dr. First Name: Job Title: Organization: Mailing Address: Telephone: Email: Fee: (see fee structure below) 1 attendee $225 2-5 attendees $180 (per attendee)(20% Discount) 6-10 attendees $153 (per attendee)(32% Discount) 11-20 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: 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 info@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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