RCA Radio
30 episodes - English - Latest episode: 4 months ago - ★★★★★ - 11 ratingsRCA 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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Episodes
Global Regulatory Standards
December 19, 2023 21:00 - 22 minutes - 15.7 MBIn 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...
Technical Program Management
February 24, 2023 18:00 - 9 minutes - 6.48 MBIn 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 wit...
2023 Industry Outlook - Pharmaceutical
January 25, 2023 16:00 - 26 minutes - 18.1 MBIn 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 continued expan...
DHF & Design Control
July 26, 2022 15:00 - 14 minutes - 10.2 MBIn 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 us...
What is Irritation and Sensitization?
June 10, 2022 20:00 - 27 minutes - 19.3 MBIn 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 s...
Outsourcing and Staff Augmentation
May 26, 2022 19:00 - 14 minutes - 9.99 MBIn 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 mat...
What is ISO 13485?
May 03, 2022 15:00 - 13 minutes - 9.09 MBIn 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 l...
What is Cytotoxicity?
February 21, 2022 23:00 - 30 minutes - 20.9 MBIn 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-clinical testing/biocompatibility for medical devices by taking a deep dive into cytotoxicity testing o...
2022 Industry Outlook - Pharmaceutical
January 25, 2022 14:00 - 22 minutes - 15.3 MBIn 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 expansion of cell and gene therapies, mRNA technologies, virtual manufacturers, virtual inspectio...
Intro to Pre-Clinical Testing and Biocompatibility
January 20, 2022 15:00 - 32 minutes - 22.3 MBIn 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-clinical testing/biocompatibility for medical devices. We cover the basic background of pre-clinical te...
2022 Industry Outlook - Medical Device
January 04, 2022 15:00 - 32 minutes - 22.2 MBIn 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 leachables (E&L) Expert. Listen in as we provide an outlook into the most important things happenin...
Laboratory Out-of-Specification Investigations
November 09, 2021 15:00 - 29 minutes - 20.3 MBIn 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 few examples from warning letters that are available to the public. About RCA Regulatory Comp...
Case Study: Quality Complaint Investigations
October 26, 2021 14:00 - 10 minutes - 7.28 MBIn 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 for the industry while addressing their Quality Complaint warning letter. About RCA Regulatory...
Case Study: Warning Letter Remediation
October 12, 2021 14:00 - 11 minutes - 7.74 MBIn 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 place, and some advice on FDA Investigation Readiness. Stay tuned for Part 2 of this case study once we ha...
What Makes a Great Quality Management System
September 22, 2021 14:00 - 14 minutes - 10.2 MBIn 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 regulatory challenges: Pharmaceutical Biologic & Biotechnology Sterile compounding Medical devic...
Design of Protocols for Biologics
August 31, 2021 19:00 - 43 minutes - 29.8 MBIn 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. (RCA) provides worldwide services to the following industries for resolution of compliance and regulat...
Design of Protocols for Biologics
August 31, 2021 19:00 - 43 minutes - 29.8 MBIn 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. (RCA) provides worldwide services to the following industries for resolution of compliance and regulat...
2021 Industry Outlook - Pharmaceuticals
February 24, 2021 17:00 - 28 minutes - 19.5 MBIn 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 the modern quality professional, data collection, knowledge management, and pharmacy compounding. ...
2021 Industry Outlook - Medical Device
February 09, 2021 15:00 - 30 minutes - 20.6 MBIn 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 (GDPR), unique device identifier (UDI), and the European Databank on Medical Devices (EUDAMED). ...
Data Integrity and Quality Culture During the Pandemic
December 08, 2020 18:00 - 28 minutes - 19.6 MBAmong 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 Schniepp, RCA's Distinguished Fellow, discuss why Data Integrity and Quality Culture are more import...
Virtual Audits and Inspections
October 15, 2020 17:00 - 24 minutes - 16.6 MBCompanies in almost every industry across the world have had to adjust due to the pandemic by moving key face-to-face activities into a virtual platform. In this episode of RCA Radio, host Brandon Miller and guest Steven Lynn, Regulatory Compliance Associates (RCA) Executive Vice President of Pharmaceuticals, discuss Virtual Audits and Inspections. Listen in as we address how the FDA performs virtual audits and inspections, some best practices for conducting these audits and inspections, a...
Ageing Facilities and In-Shoring Product to the US
September 01, 2020 17:00 - 38 minutes - 26.6 MBCompanies across the United States and around the world currently evaluating their supply chains as well as in-sourcing their manufacturing needs. In this episode of RCA Radio, host Erika Porcelli and guest Brendan McCrea, Regulatory Compliance Associates (RCA) Director of Validation Program Management, discuss how companies can update their aging facilities and the benefits of In-Shoring products. Listen in as we address the considerations that manufacturers should take into account when ...
Aging Facilities and In-Shoring Product to the US
September 01, 2020 17:00 - 38 minutes - 26.6 MBCompanies across the United States and around the world currently evaluating their supply chains as well as in-sourcing their manufacturing needs. In this episode of RCA Radio, host Erika Porcelli and guest Brendan McCrea, Regulatory Compliance Associates (RCA) Director of Validation Program Management, discuss how companies can update their aging facilities and the benefits of In-Shoring products. Listen in as we address the considerations that manufacturers should take into account when ...
Supply Chain Risk Management
July 13, 2020 18:00 - 14 minutes - 9.81 MBWith manufacturers in the United States and around the world facing problems with their supply chains, it is important to know how to identify and mitigate the risks involved. In this episode of RCA Radio, host Erika Porcelli and guest Larry Servi, Regulatory Compliance Associates (RCA) Director of Program Management, to discuss how companies can tighten their Risk Management to help mitigate the potential risks that hurt supply chains. Listen in as we address the benefits of having multip...
Expedited Approvals and the Regulatory Impacts and FDA’s Long Term Strategy
June 15, 2020 15:00 - 35 minutes - 24.1 MBWith the Covid-19 pandemic sweeping the globe, manufacturers in the United States and around the world are facing problems keeping their supply chains intact. In this episode of RCA Radio, host Erika Porcelli and guests Susan Schniepp, Regulatory Compliance Associates (RCA) Distinguished Fellow and Parental Drug Association (PDA) Chair-Elect, and Lisa Michels, RCA's General Counsel & Regulatory Affairs Expert, continue to discuss the regulatory impacts with Emergency Use Authorizations as w...
Supply Chain Management: Audit Effectiveness and Oversight
May 07, 2020 15:00 - 17 minutes - 12.1 MBWith the Covid-19 pandemic sweeping the globe, manufacturers in the United States and around the world are facing problems keeping their supply chains in tacked. In this episode of RCA Radio, host Erika Porcelli and guest Susan Schniepp, Regulatory Compliance Associates (RCA) Distinguished Fellow and Parental Drug Association (PDA) Chair-Elect, discuss the problems these companies are facing and how to address and try to overcome the new distancing regulations put in place to combat the spre...
Regulating Cannabis
November 01, 2019 17:00 - 27 minutes - 19.3 MBFrom the legalization of recreational marijuana to the growing popularity of CBD-infused products, the cannabis industry is all abuzz in the United States. But how is it regulated? In this episode of RCA Radio, host Erika Porcelli and guest Neil Pankau, Regulatory Compliance Associates (RCA) Executive Vice President of Pharmaceuticals, discuss this burgeoning industry, the regulatory framework governing it, anticipated regulatory developments at the federal and state level, and the FDA's lik...
Outsourcing Surveillance Activities
September 09, 2019 15:00 - 29 minutes - 20 MBIn this episode of RCA Radio, host Erika Porcelli and guest Steve Cox, a Regulatory Compliance Associates (RCA) Senior Consultant, cover the business strategy of outsourcing surveillance activities in both the medical device and pharmaceutical industries. Not recognized as a business strategy until the late 1980s, outsourcing is now looked at as a strategic partnership for businesses, growing increasingly in the U.S. with many key considerations at play. Listen in as we discuss a brief hist...
Data Integrity and Quality Culture
August 05, 2019 19:00 - 29 minutes - 20 MBIn this episode of RCA Radio, host Erika Porcelli and guest Susan Schniepp, Distinguished Fellow at Regulatory Compliance Associates (RCA), examine the resurgence of data integrity issues and the focus of global regulatory agencies. With the recent rise in data integrity-related citations, global regulatory bodies including the FDA, MHRA, World Health Organization, and PIC/S, have released documents to reeducate the pharmaceutical industry on data integrity concepts. Many of these guidelines...
Artificial Intelligence & Machine Learning-Based Software as a Medical Device
June 04, 2019 03:00 - 36 minutes - 16.8 MBIn our first episode of RCA Radio, host Erika Porcelli and guest Lisa Michels, General Counsel & Regulatory Affairs Expert at Regulatory Compliance Associates (RCA), examine the FDA's proposed regulatory framework for modifications to artificial intelligence and machine learning (AI/ML)-based software as a medical device. We dive into the FDA discussion paper, what AI/ML software are and how they work in medical devices, and discuss how potential risk factors resulting from this software's ...