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GMP Requirements 2016 - Conference about Combination Products: FDA's Final Rule for GMP Requirements



VenueFremont, USA - United States USA - United States

KeywordsPractices in gmp requirements; Pharmaceutical gmp products; Combination Products in gmp


Topics/Call fo Papers

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
Engineering/Technical Services/Operations
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
Event Link :
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Last modified: 2016-04-12 18:40:47