Cleaning-Sterilization-Disinfection Validation of Reusable Medical Devices
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1 Microrite, Inc. brings you this unique learning experience in Cleaning-Sterilization-Disinfection Validation of Reusable Medical Devices; Part of Microrite s step-by-step webinar series. Validation of reusable medical devices is in the forefront of the FDA s efforts to ensure patient safety. It seems like the requirements for cleaning, disinfection, and sterilization of reusable medical 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? March 24 th, :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
2 Benefits to the participants: March 24 th, 2015 Discussion of the FDA s draft guidance for Industry and FDA staff Processing/Preprocessing Medical Devices In Healthcare Settings Methods used for cleaning validation of reusable devices Methods for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? Nicholas Dassatti Group Leader Reusable Medical Device Testing at Accuratus Lab Services, Inc. Nick has 3 years experience in the microbiology laboratory and is currently a study director for reusable medical device validations. His team is responsible for performing cleaning, sterilization, and disinfection validations on reusable medical devices at Accuratus Lab Services, Inc. He has 2 years experience in equipment validation including validation of steam sterilizers and washer-disinfectors. Nick holds a BS degree in Biology and is a Registered Microbiologist in Pharmaceutical and Medical Device - American Society for Microbiology. Philip Nosel Supervisor Reusable Medical Device Testing at Accuratus Lab Services Phil has 25 years of experience in the laboratory, the last two in his current position after spending time (3 years) in the Analytical Chemistry and Quality Assurance (3 years) departments at Accuratus (formally Microtest Labs). Phil holds a BS degree in Chemistry and an MS degree in Biochemistry. Prior to joining Accuratus 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. Phil is the author of the Management Brief Automatic Washer Validation for Medical Devices available at Phil s lab routinely performs cleaning validations on reusable and one-time use medical devices using quantitative endpoints.
3 REGISTRATION FORM Personal Information of One Registrant Last Name: Mr. Ms. Dr. First Name: Job Title: Organization: Mailing Address: City/State/Zip Telephone: Fee: (see fee structure below, all costs are per attendee) 1 attendee $ attendees $180 (per attendee)(20% Discount) 6-10 attendees $153 (per attendee)(32% Discount) 11 or more 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 webinars@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.
4 Additional Attendees First and Last Name
5 Choose One (Place X) VISA Master Card American Express Card Holder s Name Address of Card Holder: Enter firm address for corporate card or personal address for personal card Street: City/State: Zip Code: Country: Contact Ph No & Card Number: Expiration(Month/Year): Amount (US Dollars): Signature: Name of Attendee(s) Referred by: Kindly note the name of the company or person that referred you to this workshop. We would like to thank them.
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