Webinar on Combination Products: FDA's Final Rule for GMP Requirements

Event Details

Time: May 26, 2016 from 10am to 11:30am
Location: Online Event
Street: 161 Mission Falls Lane, Suite 216
City/Town: Fremont
Website or Map: http://bit.ly/GMP_Requirements
Phone: 18004479407
Event Type: webinar
Organized By: Adam Fleming
Latest Activity: Mar 29, 2016

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Event Description

Overview:

What is a combination product? What are some examples of combination products? How are combination products assigned for review? Where can I find guidance for how master files can be used in the submission of information relevant to my combination product? Determine which Center will review my combination or non-combination product?

Areas Covered in the Session:

Introduction to Combination Products if you design, develop, produce, distribute and deploying a sustainable regulatory strategy
Description and explanation of FDA's proposed rule
Requirements for Single-Entity and Co-Packaged Combination Products
Identify requirements that apply to the constituent parts of a Combination Product before they are combined, or packaged together
What current good manufacturing practice requirements apply to my combination product?
Learn FDA's new terms and phrases
Understand how to address a Request for Designation for a combination or non-combination product and examples of "combo" products
Resources and guidance to help define a proven regulatory strategy

Who Will Benefit:

All levels of management and departmental representatives and those who desire a better understanding or a "refresh" overview
Regulatory Affairs
Clinical Affairs
Quality and Compliance
Marketing & Sales
Distributors
Engineering/Technical Services/Operations
Consultants

Speaker Profile:

David R. Dills , Regulatory Affairs & Compliance Consultant currently provides regulatory, compliance and quality consultative services for medical device and pharmaceutical/combination manufacturers, and also has an accomplished record with more than 24 years of experience with Class I/II/III medical devices, In Vitro diagnostics, and pharmaceuticals in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by medical device manufacturers and consultancies, including a globally recognized CRO.

Contact Detail:

Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com
http://www.compliance4all.com/
Event Link : http://bit.ly/GMP_Requirements

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