Environmental Monitoring Requirements and Best Practices for Medical Devices and Drugs New AAMI and ISO EM Reference Documents and Standards

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1 Microrite, Inc. brings you this unique learning experience in Environmental Monitoring Requirements and Best Practices for Medical Devices and Drugs; Part of Microrite s step-by-step webinar series. Environmental Monitoring Requirements and Best Practices for Medical Devices and Drugs As professionals in the medical device and pharmaceutical industries, we know that having an environmental monitoring program is required but does everyone truly understand what it means to have a comprehensive environmental monitoring program? Recently some new EM reference documents have been added to the arsenal of standards out there for our review. This webinar will discuss PDA technical report 13, 2014; AAMI TIR 52, 2014 and ISO When? October 28 th, :30pm to 3:30pm Eastern Standard Time Which industries does this webinar apply to? Pharmaceuticals, Biotechnology, Cosmetics, Medical Devices, Food and Beverage Manufacturing, and In Vitro Diagnostics Who will benefit? Quality Assurance, Quality Control, Regulatory Affairs, Microbiology, Facilities, Manufacturing, Validation, Engineering and Training Personnel

2 October 28 th, 2014 Benefits to the participants: Purpose of an Environmental Monitoring Program - discussion on standards and guidelines Link between viable counts and non-viable particle counts Considerations creating an EM program Setting Limits Creating sampling plans for the intended use of the controlled environment Reacting to aberrant results Managing environmental data Microbial characterization requirements Who will be teaching? Jason Hoffbeck is an experienced microbiologist with over 17 years of microbiology and management experience working for companies such as Medtronic and Boston Scientific. In his 13 years at Boston Scientific, culminating in the role of Microbiology Manger, Jason led multiple internal laboratory startups at both domestic and international locations. Jason s interest is in providing expert microbiology consulting services to the medical device industry. With extensive experience in creating and maintaining environmental monitoring programs supporting the manufacture of class III medical device, Jason excels in sampling plan development and statistical limit setting for both product and processes.

3 REGISTRATION FORM Environmental Monitoring Requirements and Best Practices for Medical Devices and Drugs Personal Information of One Registrant Last Name: Mr. Ms. Dr. First Name: Job Title: Organization: Mailing Address: 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.

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