Events

As global regulatory pressures tighten and supply chain challenges increase, medical device manufacturers are increasingly considering changes to sterilization modalities—whether due to material compatibility, environmental impact, or technology accessibility. However, transitioning from one sterilization method to another is a complex process that requires a rigorous, structured decision flow to ensure patient safety, product efficacy, and regulatory compliance.

This webinar will provide a comprehensive overview of the critical considerations and step-by-step process involved in changing sterilization modalities for medical devices. Topics will include feasibility assessment, risk-based decision making, material compatibility studies, and the planning and execution of validation testing, and maintaining regulatory compliance. Additionally, this webinar will explore the regulatory landscape, with guidance on engaging with global regulatory bodies, compiling robust technical documentation, and navigating submission requirements.

Whether you are planning a modality change due to EO reduction initiatives,  supply chain challenges, material compatibility issues or the adoption of newer methods such as X-ray or nitrogen dioxide, this webinar will equip you with the practical knowledge to manage the transition effectively and compliantly.

Who Should Attend:
Regulatory Affairs professionals, Quality Assurance/Validation Engineers, R&D Managers, Sterilization Specialists, and anyone involved in medical device lifecycle management.

With the FDA increasing unannounced and remote inspections, continuous inspection readiness is more important than ever. This webinar offers a focused look at preparing your facility, emphasizing internal audits and structured readiness strategies to support sustained compliance. We’ll explore best practices for front-room and back-room coordination, team roles, and engaging with FDA investigators.

Learn how to ensure your quality system records—including investigations, CAPAs, and contamination controls—can withstand regulatory scrutiny. Attendees will also gain insights into data integrity and alignment with current FDA guidance, such as policies on delaying or limiting inspections. We’ll outline how to effectively manage and respond to Form 483s and warning letters, with emphasis on strong corrective action planning and communication.

Whether preparing for a pre-approval, pre-license, or routine GMP inspection, this session provides practical tools to help regulatory and quality teams maintain a state of readiness and reduce inspection-related risk.

A robust quality culture is no longer a nice to have—it’s a regulatory and operational imperative. Join us for an in-depth exploration of PDA/ANSI Standard 06-2025: Assessment of Quality Culture, a landmark guidance developed to help life science organizations strengthen and assess their internal quality culture.

This webinar will provide a concise overview of the new standard, including its purpose, scope, and structure. You’ll gain actionable insights into why quality culture matters, the critical factors that shape it, and how leadership and organizational enablers drive lasting cultural change. Using real-world scenarios and questions adapted from industry publications, we’ll demonstrate how culture can falter and how this standard offers a practical, proactive tool to assess and improve culture.

Through side-by-side comparisons, you’ll learn how to apply the standard within your own systems and identify areas for improvement using proven models and assessment tools.

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