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Listen in as we go over the background of ISO 13485 and give some useful information for companies preparing to implement or make updates.... Read More

Listen in as Matt and Helin help educate our listers about the world of pre-clinical testing/biocompatibility for medical devices by taking a deeper dive into cytotoxicity testing of medical devices in this part of the Intro into Biocompatblity podcast series.... Read More

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 inspections, ongoing supply chain issues, and the compliance hurricane that is forming.... Read More

Listen in as Matt and Helin help educate our listers about the world of pre-clinical testing/biocompatibility for medical devices.... Read More

Listen in as we provide an outlook into the most important things happening in 2022 to the medical device industry such as; New technology uses cases, new notified body regulations, upcoming onsite inspections, supply chain issues, and much more.... Read More

Listen in as we go over best practices for dealing with laboratory Out of Specification investigations, relevant guidance documents, and a few examples from warning letters that are available to the public.... Read More

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.... Read More

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 have completed the entire project.... Read More

Listen in as we go over how the people, processes, and documentation all come together to make a Quality Management System... Read More

Listen in as we go over the design of biologic protocols, the importance of keeping data, and the different methods of analyzing data.... Read More

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.... Read More

Listen in as we 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). ... Read More

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.... Read More

Listen in as we address how the FDA performs virtual audits and inspections, some best practices for conduction these audits and inspections, as well as how companies can prepare for this type of remote work.... Read More

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. ... Read More

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.... Read More

Listen in as we go over expedited approvals and relevant regulatory impacts as well as the FDA's long term inspection strategy moving forward.... Read More

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.... Read More

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.... Read More

We cover the business strategy of outsourcing surveillance activities in both the medical device and pharmaceutical industries.... Read More

Examine the resurgence of data integrity issues and the focus of global regulatory agencies, whose guidelines include an element of quality culture... Read More

Learn about the FDA's proposed regulatory framework for artificial intelligence and machine learning-based software as a medical device... Read More

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Parenteral Products Sterilization and Extractables Evaluation to Help Ensure Drug Safety...
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Parenteral Products Sterilization and Extractables Evaluation to Help Ensure Drug Safety...
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