RCA Radio

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. 

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. 

 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 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's long term inspection strategy moving forward. 

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.

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'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.

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.

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.

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'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 ability to adapt or change have led the FDA to propose a new total product lifecycle approach, eliciting industry feedback in the process.