As combination products, such as prefilled syringes, auto-injectors, and drug-device kits, become more prevalent, pharmaceutical and biologic companies must adapt their existing Quality Management Systems (QMS) to meet regulatory expectations for medical device development.
This webinar will introduce the streamlined approach outlined in 21 CFR Part 4.4, it will break down the six core QMS elements required for compliance and offer strategic insights into implementation. Whether you’re considering outsourcing, building internal capabilities, or simply seeking clarity on design controls and risk management, this session will help guide your next steps in developing a compliant and scalable program for combination products.
Learning Objectives:
By the end of this webinar, attendees will be able to:
- Understand the regulatory requirements for combination products under 21 CFR Part 4.4 and how they impact existing pharma/biologic QMS frameworks.
- Identify and implement the six key QMS elements required for combination products: management responsibility, design controls, purchasing controls, CAPA, installation, and servicing.
- Recognize the complexities of design controls, including human factors, verification/validation, risk management and essential drug delivery output (EDDO) testing.
- Evaluate implementation strategies, including outsourcing vs. internal development, and understand the staffing and resource implications.
- Assess cybersecurity considerations for connected combination products and understand how software and data integrity requirements fit into the QMS.
