Technology Transfer Critical Points to Consider

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1 Microrite, Inc. brings you this unique learning experience in - ; Part of Microrite s step-by-step webinar series. A technology transfer can easily make the difference between a successful or failed project. It is therefore essential in getting it right the first time. In this webinar we will look at how to derive, implement, and manage a successful technology transfer project; lifting technology transfer off the page and putting it into practical context that can be readily applied in the field. When? November 6 th, :30pm to 3:30pm Eastern Standard Time Which industries does this webinar apply to? Pharmaceuticals, Biotechnology, Medical Device, Food, and In Vitro Diagnostics Who will benefit? Quality Assurance, Quality Control, Regulatory Affairs, Manufacturing, R&D, Engineering, Validation, and Training Personnel

2 November 6 th, 2014 Benefits to the participants: Technology transfer fundamentals and application Process and analytical methods transfer and acceptance criteria Knowledge transfer Control strategy and quality aspects: managing process changes Process and product comparability Approaches for classical recombinants, biosimilars and advanced therapy medicinal products Scale up, site to site transfer, outsourcing Process design envelope and facility considerations Early and late stage transfers Regulatory ICH guidelines Quality risk management Design, planning, delivery, project management Avoiding problems and keeping things on track Impact on regulatory submissions Who will be teaching? Ronald Berk is VP of engineering for Hyde Engineering + Consulting, Inc., a firm of 185 engineers and scientists founded in 1993 and specializing in process and control systems engineering, process and equipment validation, and compliance consulting for biopharmaceutical and pharmaceutical process systems. He is responsible for engineering design projects. His expertise includes project management, process design, control systems and validation services for biopharmaceutical and related processes. Ronald has extensive experience in project management, process CIP/SIP integrated design and compliance for biopharmaceutical pilot and production facilities; as well as specification, development and startup of skidded and plant wide control systems. He has also managed several large scale cleaning validation programs. He holds a Bachelor s degree in chemical engineering with a minor in business management, from the Technical College of Amsterdam.

3 REGISTRATION FORM 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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