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 introduces the streamlined approach outlined in 21 CFR Part 4.4, it breaks down the six core QMS elements required for compliance and offers 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.
