Medical Device Director
- Outlining the considerations for monitoring and maintenance of combination products throughout the entire project lifecycle
- What are the impacts of regulatory changes, marketing needs or production issues?
- The importance of developing technical documentation and supporting processes: What are the key things to include, implementation strategy and potential risks to be aware of?
- Managing change: Precisely monitoring the change control process based on the documentation
- What are the biggest challenges you are facing currently with developing and managing combination products?
- What are the unique characteristics of combination products and how does it impact the design parameters?
- What are the critical success factors for combination products? What are key requirements and success factors in selecting device manufacturing and design partners?
- How can different materials influence the design, development and compliance of combination products?
- What advice would you give in terms of testing combination products and the critical requirements for essential performance?
8:15 AM Workshop A: Combination Products cGMPs: Application of FDA Medical Device Regulations Required by the Drug cGMP Streamlined Approach of 21 CFR Part 4
Pharmaceutical companies that have traditionally designed and manufactured combination products for the U.S. need to update their quality management system to the device requirements of 21 CFR Part 4. Although most of the industry is aware and doing their best to comply, guidance is still needed on how to implement and maintain compliance. This workshop will focus on a deep dive review on the elements of 21 CFR 820 quality system regulations for medical devices that are outlined in the drug cGMP streamlined approach of 21 CFR Part 4 Combination Products Final Rule: Management Responsibilities, Design Controls, Purchasing Controls, Corrective and Preventive Action, Installation, and Servicing.
Attend this workshop to:
- Gain an applied knowledge on the medical device requirements for combination products
- Gain the skill of assessing a combination product developer or manufacturer
- Gain applied knowledge of the regulations via real world case studies of FDA 483s and warning letters of medical device and combination product developers/manufacturers
- Brainstorm to create tools and forms that can be used on current projects related to combination product development such as:
- Management Review Forms
- Quality Planning Approach
- Design History File Traceability Matrix
- Design History File Remediation