Events

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