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 compounding.  Listen in as we go over the importance of these Pharmaceutical incentives, some of the potential problems companies are facing during implementation, and some alternatives to mitigate those problems.

RCA Radio

2021 Industry Outlook - Pharmaceuticals

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 (EUDAMED).  Listen in as we go over the importance of these medical device incentives, some of the potential problems companies are facing during implementation, and some alternatives to mitigate those problems.

2021 Industry Outlook - Medical Device

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 important now than ever before. Listen in as we address why Data Integrity and Quality Culture are so important, permanent changes as a result of the pandemic, how to leverage the changes, and how it is all related to having a good quality culture. 

Data Integrity and Quality Culture During the Pandemic

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 well as how companies can prepare for this type of remote work.

Virtual Audits and Inspections

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 evaluating these In-Shoring projects and the risk-based approach that the FDA is taking for evaluating site inspections. 

Aging Facilities and In-Shoring Product to the US

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 multiple sources for your supply chain and things that can be done to help reduce and relax the qualification requirements. 

Supply Chain Risk Management

 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&apos;s General Counsel & Regulatory Affairs Expert, continue to discuss the regulatory impacts with Emergency Use Authorizations as well as how to address and try to overcome the new distancing regulations put in place to combat the spread of Covid-19.Listen in as we go over expedited approvals and relevant regulatory impacts as well as the FDA&apos;s long term inspection strategy moving forward. 

Expedited Approvals and the Regulatory Impacts and FDA’s Long Term Strategy

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 spread of Covid-19.Listen in as we go over Audits Effectiveness and Oversight of Service Providers and break down the different ways companies can work virtually to get audits done successfully. The challenges with recording audit findings and conducting interviews. What companies can do to audit suppliers and maintaining their supply chains. As well as answer the questions; is virtual auditing going to be a long term solution, and what companies can do to maintain oversight of service providers.

Supply Chain Management: Audit Effectiveness and Oversight

From 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&apos;s likely path on oversight. Listen in as we break down key terminology, discuss the impact to businesses working with cannabis-based products, examine the controls and guidelines businesses should consider whether new or entering the industry, and share our thoughts on the future regulation and sale of these products.

Regulating Cannabis

In 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 history of outsourcing and its impact on the U.S. labor market, functions primary to an outsourcing strategy and the traits they share, the steps and timeline necessary to outsource a workflow, the pros and cons to this strategy, potential change paradigms that could arise, and regulatory considerations.

Outsourcing Surveillance Activities

In 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 include an element of quality culture.We break down these guidelines and examine the history of data integrity, what it means to have a quality culture, and how to integrate a quality culture in the product lifecycle. No longer just the concern of the quality control unit, data integrity is the concern of an entire organization, bringing forth the concept that your data is only as good as the culture of your company.

Data Integrity and Quality Culture

In 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&apos;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&apos;s ability to adapt or change have led the FDA to propose a new total product lifecycle approach, eliciting industry feedback in the process.

Artificial Intelligence & Machine Learning-Based Software as a Medical Device

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

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RCA Radio

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