RCA Radio

Regulatory Compliance Associates
  • 5.0 (11)
  • ARTE
RCA Radio

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.

  1. 23 OCT

    New FDA draft guidance for Chemical Analysis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...

    14 min

  2. 19/12/2023

    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...

    23 min

  3. 24/02/2023

    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...

    9 min

  4. 25/01/2023

    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...

    26 min

  5. 26/07/2022

    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...

    15 min

  6. 10/06/2022

    What is Irritation and Sensitization?

    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 biocompatibility for launching your products in this part of the Intro into Biocompatblity podcast seri...

    28 min

  7. 26/05/2022

    Outsourcing and Staff Augmentation

    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 on to talk about the process of augmenting your staff, the benefits, and why having a subject matter...

    14 min

  8. 03/05/2022

    What is ISO 13485?

    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 update the standard.He also touches on the current proposed amendments by the FDA. If you would like t...

    13 min
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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.

Información

  • Creador
    Regulatory Compliance Associates
  • Años de actividad
    2019 - 2024
  • Episodios
    29
  • Clasificación
    Apto
  • Copyright
    © 2024 RCA Radio
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    RCA Radio

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