Combination Products: FDA`s Final Rule for GMP Requirements and Introduction and Expectations for `Combo` Products 2015 is a webinar that covers topics such as:
- 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
Combination Products: FDA`s Final Rule for GMP Requirements and Introduction and Expectations for `Combo` Products 2015 brings together:
- Clinical Affairs
- Regulatory Affairs
- Marketing & Sales
- Quality and Compliance
- Engineering/Technical Services/Operations
- Distributors
- Consultants