Microrite, Inc. brings you this unique learning experience in Cleaning-Disinfection-Sterilization of Reusable Medical Devices; Part of Microrite s step-by-step webinar series. Cleaning-Disinfection-Sterilization Validation is in the forefront of FDA s efforts to ensure patient safety. It seems like requirements for cleaning, disinfection and sterilization of reusable devices are constantly changing leaving manufacturers with a dilemma as to the methods to use and the end points to test for. Knowledge of current regulatory expectations may increase the chances of submissions being accepted without requiring additional testing. This webinar will address the most current regulatory expectations for cleaning, disinfection and sterilization validations of reusable medical devices. When? November 1 4 th, 2013 1:30pm to 3:30pm Eastern Standard Time Which industries does this webinar apply to? Medical Device Who will benefit? Quality Assurance, Quality Control Microbiologists, Manufacturing, Validation, Engineering and Training personnel
November 14 th, 2013 This 2 hour course will include: Discussion of FDA s draft guidance for Industry and FDA staff Processing/Preprocessing Medical Devices in Healthcare settings Methods used for cleaning validation of reusable devices Methods for disinfection of reusable devices Methods for sterilization of reusable devices Testing requirements Detailed discussion of endpoints for cleaning validation Expert advice on risk based approach for setting end points Who will be teaching? Philip Nosel, Supervisor Reusable Medical Devices at Microtest Laboratories Inc. has over 20 years experience in the lab, spending the past 4 years in the Analytical Chemistry department at Microtest after spending 3 years in the Quality Assurance department at Microtest. Philip holds a BS degree in Chemistry and an MS degree in biochemistry. Prior to joining Microtest Phil worked as a chemist and QA analyst at various companies supporting manufacturing, R&D and QC. Phil is a member of the American Chemical Society and AAMI Committee WG84, Endoscope Reprocessing. Philip is the author of the Management Brief Automatic Washer Validation for Medical Devices available at www.microtestlabs.com. Philip s lab routinely performs cleaning validations on reusable and one-time use medical devices using quantitative endpoints. Deborah Ensign, Supervisor R&D Lab at Microtest Laboratories Inc., has over 20 years experience in regulatory microbiology and contract laboratory operations. Deborah supervises Microtest s Specialized Microbiology department which routinely performs disinfectant qualifications, USP <61>, <62> and <81>, as well as filter challenges and phage testing. She holds a Bachelor of Arts degree in microbiology and has been a nationally registered microbiologist for over 15 years. Deborah serves as a resource for USP testing and reusable device disinfection and sterilization testing. She is a coauthor of the Management Brief The Background Behind Disinfection Qualifications as well as the author of the white paper Six Steps to Qualifying Disinfectants published in Contract Pharma. Both are available at www.microtestlabs.com.
REGISTRATION FORM Personal Information of One Registrant Cleaning-Disinfection-Sterilization 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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