RCA Radio

In this episode of RCA Radio, host Brandon Miller is joined by cybersecurity experts Jason Tugman of Regulatory Compliance Associates® and Mustanir Ali of BSI to unpack the evolving landscape of cybersecurity in medical devices. Together, they explore the latest FDA and EU guidance, the growing expectations for connected device security, and the top gaps companies face when bringing products to ma...

In this episode of RCA Radio, host Brandon Miller sits down with Jessica Schafersman, a design and development expert at RCA®, to break down the increasingly complex world of combination products—those that blend drugs, devices, or biologics. Jessica shares insights on why these products are uniquely challenging, the regulatory expectations companies must meet, and how the FDA guidance that is int...

In this episode of RCA Radio , host Brandon Miller is joined by RCA experts Anita Michael and Arie Anahory for a deep dive into the evolving world of compounding pharmacies. Together, they explore the critical role compounders play in personalized medicine, their differences from traditional pharmaceutical manufacturers, and the increasing regulatory scrutiny they face—especially 503B outsourcing...

 In this episode of RCA Radio®, host Brandon Miller is joined by Rod Mell, Executive Head – Life Science Consulting at RCA, as well as Jordan Elder, Director of Regulatory both at Regulatory Compliance Associates. We explore possible changes in the Medical Device industry in 2025 and provide you with insight on how to prepare yourself for these upcoming initiatives. Listen in as we go over updated...

In this episode of RCA Radio®, host Brandon Miller is joined by Anita Michael, Executive Pharma Compliance Expert & Principal Consultant and Rona LeBlanc-Rivera, Director, Regulatory Affairs both at Regulatory Compliance Associates®.  We explore possible changes in the Pharmaceutical industry in 2025 and provide you with insight on how to prepare yourself for these upcoming initiatives. Listen...

In this episode of RCA Radio, host Brandon Miller is joined by Nelson Labs Director of E&L Raymond Colton as well as board certified toxicologist Dr. Sarah Campbell also from Nelson Labs to discuss the recent draft FDA GUIDANCE DOCUMENT: Chemical Analysis for Biocompatibility Assessment of Medical Devices. Listen in as we cover why this guidance why is important, the potential impacts of this...

In this episode of RCA Radio, host Brandon Miller is joined by Jordan Elder , Regulatory Compliance Associates'® (RCA) Regulatory Expert. Kinga Demetriou, an Expert Certifier at BSI , and Nathan Shipley, a Global Certification Manager at BSI to discuss the current trends and challenges with Regulatory Requirements US and EU while focusing on personal protective equipment. Listen in as we cove...

In this episode of RCA Radio, host Brandon Miller is joined by Eric Januszewski, Senior Director of Client Relations for US and Europe, at Regulatory Compliance Associates® (RCA) to talk about outsourced technical program management and the increased demand caused by the shortage of qualified subject matter experts. Listen in as Eric goes over what outsourced program management is, the benefits cl...

 In this episode of RCA Radio, host Brandon Miller, Steve Lynn , and Susan Schniepp explore what is happening in the Pharmaceutical industry in 2023 and provide you with insight on how to prepare yourself for these upcoming initiatives. Steve is Regulatory Compliance Associates®  (RCA) Executive Pharmaceutical Consultant and Susan is the chair of PDA and as well as a Distinguished Fellow at RCA. ...

In this episode of RCA Radio, host Brandon Miller is joined by Jessica Schafersman, Biomedical Engineer, Project Management Professional, and Certified Usability Analyst at Regulatory Compliance Associates® (RCA) to talk about Design controls and the proper way to go about developing your DHF for your Medical Device products. Jessica has over 20 years of experience in medical product development....

In this episode of RCA Radio, host Brandon Miller is joined by Dr. Matthew Jorgensen and Audrey Turley, Matt a board-certified toxicologist with a Ph. D. in chemistry and is Nelson Laboratory’s Chemistry and Materials Scientist and Audrey is a Nelson Labs Senior Biocompatibility Expert. Listen in as Matt and Audrey help educate our listers about Irritation and Sensitization in medical devices bioc...

In this episode of RCA Radio, host Brandon Miller is joined by Erica Porcelli , CEO of Regulatory Compliance Associates® (RCA) , to going to over outsourcing leadership roles and how companies use staff augmentation to jump-start their teams. Listen in as we talk about what outsourced leadership and staff augmentation are by providing brief background and current trends in the industry. Then move...

In this episode of RCA Radio, host Brandon Miller is joined by Jordan Elder , Director of Regulatory Affairs at Regulatory Compliance Associates (RCA) to cover the Medical Device quality standard ISO 13485 and why it is important for the industry. Listen in as Jordan goes over the background of the ISO standard as well as some useful information companies can use when preparing to implement or upd...

In this episode of RCA Radio, host Brandon Miller is joined by Dr. Matthew Jorgensen and Dr. Helin Räägel, Matt a board-certified toxicologist with a Ph. D. in chemistry and is Nelson Laboratory’s Chemistry and Materials Scientist and Helin is Nelson Labs Senior Biocompatibility Expert with a Ph. D. in cell biology. Listen in as Matt and Helin help educate our listers about the world of pre-clinic...

In this episode of RCA Radio, host Brandon Miller and Steve Lynn , who is Regulatory Compliance Associates® Inc.  (RCA) Executive VP of Pharmaceuticals, explore what is happening in the Pharmaceutical industry in 2022  and provide you with insight on how to prepare yourself for these upcoming initiatives. Listen in as we go over the increase in spending in the industry as a whole, the continued ex...

In this episode of RCA Radio, host Brandon Miller is joined by Dr. Matthew Jorgensen and Dr. Helin Räägel, Matt a board-certified toxicologist with a Ph. D. in chemistry and is Nelson Laboratory’s Chemistry and Materials Scientist and Helin is Nelson Labs Senior Biocompatibility Expert with a Ph. D. in cell biology. Listen in as Matt and Helin help educate our listers about the world of pre-clinic...

In this episode of RCA Radio, host Brandon Miller , Seyed Khorashahi , and Thor Rollins explore what is happening in the medical device industry in 2022 and provide you with insight on how to prepare yourself for these upcoming initiatives. Seyed is Regulatory Compliance Associates® Inc. (RCA) Executive VP of Medical Device and CTO. Thor is Nelsons Laboratory’s Toxicology, and Extractables and lea...

In this episode of RCA Radio, host, Brandon Miller, and Regulatory Compliance Associates Inc.® Senior Director of Quality Control and Consulting Services, Walter Mason, take a deep dive into laboratory Out-of-Specification (OOS) investigations and how to get to the root cause. Listen in as we go over best practices for dealing with laboratory OOS investigations, relevant guidance documents, and a...

In this episode of RCA Radio, host, Brandon Miller , and Regulatory Compliance Associates Inc.® Senior Director of Quality Control and Consulting Services, Walter Mason, go over a case study where we tried to teach a client that received a warning letter life lessons for Quality Complaint investigations. Listen in as we break down how we helped this client and taught them an important life lesson...

In this episode of RCA Radio, host, Brandon Miller, and Regulatory Compliance Associates Inc.® Executive VP of Pharmaceuticals, Steven Lynn go over how RCA helped an international company perform a gap analysis based on multiple FDA investigations. Listen in as we break down the client's Warning Letter Remediation challenges, RCA's approach to remediation, the ongoing work still taking p...

 In this episode of RCA Radio, guest host Dean Coston and Susan Schniepp, Regulatory Compliance Associates Inc.'s (RCA) Distinguished fellow go over how the people, processes, and documentation all come together to make a Quality Management System.  About RCA Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the following industries for resolution of compliance and r...

In this episode of RCA Radio, host Brandon Miller, Steve Lynn, and Walter Mason, (Regulatory Compliance Associates Inc.'s (RCA) Executive VP of Pharmaceuticals, RCA's Sr. Director of Quality Control and Consulting Services) go over the design of biologic protocols, the importance of keeping data, and the different methods of analyzing data. About RCA Regulatory Compliance Associates® Inc...

In this episode of RCA Radio, host Brandon Miller and Steve Lynn , who is Regulatory Compliance Associates (RCA) Executive VP of Pharmaceuticals, provide an outlook into the most important things happening in 2021 to the Pharmaceutical industry such as; timeliness in regards to vaccines and EUAs, virtual inspections, cellular and gene therapy, facility modernization, data integrity, the idea of th...

In this episode of RCA Radio, host Brandon Miller and Seyed Khorashahi, who is Regulatory Compliance Associates (RCA) Executive VP of Medical Device and CTO, provide an outlook into the most important things happening in 2021 to the medical device industry such as; Brexit, the European Medical Device Regulations (EU MDR), In Vitro Diagnostic Regulation (IVDR), General Data protection regulation (G...

Among the current and emerging topics of interest to the pharmaceutical industry, the topics of quality metrics, quality culture, and data integrity are of particular concern to both the industry and the regulatory authorities. In this episode of RCA Radio, host Brandon Miller and guests Steven Lynn, Regulatory Compliance Associates (RCA) Executive Vice President of Pharmaceuticals, and Susan Schn...