Combination Products: FDA`s Final Rule for GMP Requirements and Introduction and Expectations for `Combo` Products 2015
14 Oct 2015
Online Event
Description
Topics
FDA`s proposed rule
Combination Products if you develop, design, distribute, produce and deploying a sustainable regulatory strategy
Identify requirements that apply to the constituent parts of a Combination Product before they are combined, or packaged together
Requirements for Single-Entity and Co-Packaged Combination Products
FDA`s new terms and phrases
Current good manufacturing practice requirements
Define a proven regulatory strategy
How to address a Request for Designation for a combination or non-combination product
Who should Attend
Clinical Affairs
Regulatory Affairs
Marketing & Sales
Quality and Compliance
Engineering/Technical Services/Operations
Distributors
Consultants
Past Events
Combination Products: FDA`s Final Rule for GMP Requirements and Introduction and Expectations for `Combo` Products 2015 - 14 Oct 2015, Online Event (54216)
Combination Products: FDA`s Proposed Rule for GMP Requirements and Introduction and Expectations for `Combo` Products 2015 - 24 Mar 2015, Webinar (8756)
Important
Please, check "Combination Products: FDA`s Final Rule for GMP Requirements and Introduction and Expectations for `Combo` Products" official website for possible changes, before making any traveling arrangements
Event Categories
Education: E-learning, Training
Health & Medicine: Healthcare, Medical device, Pharma