Events

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

We are happy to announce that RCA will be exhibiting with Sterigenics and Nelson Labs at the MD&M West 2026 tradeshow in Anaheim, California, February 3rd – 5th. Attend one of our educational lectures; For details about the different lectures, refer to the information provided below.

We will have consultants available to answer even the most difficult testing and compliance questions. Stop by our booth, #3135, for a complimentary, personalized 30-minute consultation.

MD&M West has developed into one of the leading medical device trade shows in the US. Inspired by the life-saving solutions and innovations that companies all over the world push to evolve, MD&M West’s mission is to unify the international medical device community together to support the growth of their company objectives and push the boundaries of the medical field to save and improve lives across the globe.

Day 1 – MedTech Theater Presentation

Tuesday February 3^rd, 2026. 1:30-2:15pm
Location: Medtech Theatre, Booth 171
Presenter: Taryn Meade Brow, Sr. Manager, EAS Technical Consulting, Nelson Labs
Title: ISO 10993-1:2025: What’s Next?
After years of discussion, the major revision of ISO 10993-1, which prescribes the biological evaluation process for medical devices, has been published. The rewrite of the standard includes changes to contact type and duration categorization, as well as relevant biological effects, and includes additional considerations for the lifetime of the device. Perhaps the most prominent change is the restructuring of the standard and its principles to align with the ISO 14971 risk management process. Now that the standard is published, this talk will discuss next steps in terms of anticipated regulatory agency adoption, future revisions, and immediate changes needed to the biological evaluation process.

Day 1 – MD&M West Coffee Talk Session

Tuesday February 3^th, 2026. 1:30-2:15pm
Location: Room 211AB
Presenters: David Tran, Technical Advisor, Radiation at Sterigenics
Jordan Elder, Director, Regulatory Affairs at Regulatory Compliance Associates^®
Title: Navigating the Decision Flow: Changing Sterilization Modalities for Medical Devices

As global regulatory pressures tighten and product designs increase in complexity medical device manufacturers are increasingly considering changes to sterilization modalities. This presentation will provide a comprehensive overview of the critical considerations and step-by-step processes involved in changing sterilization modalities for medical devices. Topics will include feasibility assessment, risk-based decision making, material compatibility studies, the planning and execution of validation testing, and maintaining regulatory compliance. Additionally, the presenters will explore the regulatory landscape, with guidance on engaging with global regulatory bodies, compiling robust technical documentation, and navigating submission requirements.