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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:

1. Understand the regulatory requirements for combination products under 21 CFR Part 4.4 and how they impact existing pharma/biologic QMS frameworks.
2. Identify and implement the six key QMS elements required for combination products: management responsibility, design controls, purchasing controls, CAPA, installation, and servicing.
3. Recognize the complexities of design controls, including human factors, verification/validation, risk management and essential drug delivery output (EDDO) testing.
4. Evaluate implementation strategies, including outsourcing vs. internal development, and understand the staffing and resource implications.
5. Assess cybersecurity considerations for connected combination products and understand how software and data integrity requirements fit into the QMS.

We are offering this complimentary 503 GMP training with our experts to provide guidance on readiness with the requirements of the current regulations for 503A/B facilities and current industry trends. Included are sessions for key questions and answers for the current FDA requirements for GMP 6 system approach for outsourcing facilities. This is a great opportunity to partner.

Key Takeaways

Focused Guidance on 503A/B Compliance: The training offers expert insights to help facilities align with current regulations for 503A and 503B compounding pharmacies.

In-Depth Coverage of GMP 6-System Approach: Sessions will address key FDA requirements related to the GMP six-system framework for outsourcing facilities, including Q&A opportunities.

Free Opportunity for Industry Collaboration: As a complimentary training, it’s positioned as a valuable chance to gain knowledge and connect with experts and industry peers.

Ready to get started? Connect with us to schedule your complimentary training session with Tayl’r Hollis who leads RCA’s Compounding Pharmacy initiative, where she partners with 503A and 503B organizations worldwide to enhance compliance, FDA readiness, and operational performance. Learn more about Tayl’r here and reach out using the contact us form below today to begin the process of setting up your customized training session today.

Use the Contact Form Below to Start the Registration Process