RCA Radio

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...

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...

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...

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-clinical testing/biocompatibility for medical devices by taking a deep dive into cytotoxicity testing...

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 expansion of cell and gene therapies, mRNA technologies, virtual manufacturers, virtual...

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-clinical testing/biocompatibility for medical devices. We cover the basic background of pre-clinical...

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 leachables (E&L) Expert. Listen in as we provide an outlook into the most important things happening...

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 few examples from warning letters that are available to the public. About RCA Regulatory...

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 for the industry while addressing their Quality Complaint warning letter. About RCA Regulatory...

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 place, and some advice on FDA Investigation Readiness. Stay tuned for Part 2 of this case study once we...

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 regulatory challenges: PharmaceuticalBiologic & BiotechnologySterile compoundingMedical deviceWe...

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. (RCA) provides worldwide services to the following industries for resolution of compliance and...

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 the modern quality professional, data collection, knowledge management, and pharmacy...

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 (GDPR), unique device identifier (UDI), and the European Databank on Medical Devices...

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 Schniepp, RCA's Distinguished Fellow, discuss why Data Integrity and Quality Culture are more...

Companies 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, as...

Companies 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...

With 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...

With 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...

With 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...