RCA Radio dari Regulatory Compliance Associates
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.
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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 companies can address and prepare in this evolving landscape. We cover things like market access, product category changes, as well audience diversification with personal protective equipment (PPE), and why the regulatory requirements are changing in these areas.
About BSI
BSI enables people and organizations to perform better. They share knowledge, innovation and best practice to make excellence a habit – all over the world, every day. Their solutions and services improve performance and support the United Nations Sustainable Development Goals. At BSI, our mission is to share knowledge, innovation and best practice to help people and organizations make excellence a habit. This is underpinned by our role as the national standards body and through our prestigious Royal Charter.
About Regulatory Compliance Associates
Regulatory Compliance Associates (RCA) provides regulatory compliance consulting to the following industries:
We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. Our life science consultants are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.
As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.
- Founded in 2000
- Expertise backed by over 500 industry subject matter experts
- Acquired by Sotera Health in 2021
Episode sebelumnya
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28 - Global Regulatory Standards Tue, 19 Dec 2023
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27 - Technical Program Management Fri, 24 Feb 2023
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26 - 2023 Industry Outlook - Pharmaceutical Wed, 25 Jan 2023
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25 - DHF & Design Control Tue, 26 Jul 2022
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24 - What is Irritation and Sensitization? Fri, 10 Jun 2022
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23 - Outsourcing and Staff Augmentation Thu, 26 May 2022
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22 - What is ISO 13485? Tue, 03 May 2022
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21 - What is Cytotoxicity? Mon, 21 Feb 2022
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20 - 2022 Industry Outlook - Pharmaceutical Tue, 25 Jan 2022
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19 - Intro to Pre-Clinical Testing and Biocompatibility Thu, 20 Jan 2022
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18 - 2022 Industry Outlook - Medical Device Tue, 04 Jan 2022
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17 - Laboratory Out-of-Specification Investigations Tue, 09 Nov 2021
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16 - Case Study: Quality Complaint Investigations Tue, 26 Oct 2021
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15 - Case Study: Warning Letter Remediation Tue, 12 Oct 2021
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14 - What Makes a Great Quality Management System Wed, 22 Sep 2021
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13 - Design of Protocols for Biologics Tue, 31 Aug 2021
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12 - 2021 Industry Outlook - Pharmaceuticals Wed, 24 Feb 2021
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11 - 2021 Industry Outlook - Medical Device Tue, 09 Feb 2021
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10 - Data Integrity and Quality Culture During the Pandemic Tue, 08 Dec 2020
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9 - Virtual Audits and Inspections Thu, 15 Oct 2020
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8 - Aging Facilities and In-Shoring Product to the US Tue, 01 Sep 2020
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7 - Supply Chain Risk Management Mon, 13 Jul 2020
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6 - Expedited Approvals and the Regulatory Impacts and FDA’s Long Term Strategy Mon, 15 Jun 2020
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5 - Supply Chain Management: Audit Effectiveness and Oversight Thu, 07 May 2020
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4 - Regulating Cannabis Fri, 01 Nov 2019
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3 - Outsourcing Surveillance Activities Mon, 09 Sep 2019
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2 - Data Integrity and Quality Culture Mon, 05 Aug 2019
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1 - Artificial Intelligence & Machine Learning-Based Software as a Medical Device Mon, 03 Jun 2019