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RCA Radio

RCA Radio

Regulatory Compliance Associates

RCA Radio covers the latest news and challenges in regulatory, compliance, and quality assurance facing the medical device, pharmaceutical, and biologic industries. In each episode, join Regulatory Compliance Associates® (RCA) and industry thought leaders as we navigate the issues that matter to you most.

29 - New FDA draft guidance for Chemical Analysis
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  • 29 - New FDA draft guidance for Chemical Analysis

    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 guidance to device manufactures, and some best practices Nelson Labs testing facilities are alread...

    Wed, 23 Oct 2024
  • 28 - Global Regulatory Standards

    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 cover the current trends in the industry, the challenges companies face in relation to the trends, and how co...

    Tue, 19 Dec 2023
  • 27 - Technical Program Management

    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 clients receive when having a technical program manager, and the heuristic approach RCA takes with t...

    Fri, 24 Feb 2023
  • 26 - 2023 Industry Outlook - Pharmaceutical

    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. Listen in as we go over the increase in spending in the industry as a whole, the con...

    Wed, 25 Jan 2023
  • 25 - DHF & Design Control

    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. She started her career in a medical device startup, working directly with physicians and end users...

    Tue, 26 Jul 2022
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