In this episode, host Erika Porcelli is joined by Brendan McCrea, Regulatory Compliance Associates (RCA) Director of Validation Program Management, to discuss how companies can update their aging facilities and the benefits of in-shoring products. As companies across the United States and around the world reevaluate their supply chains and consider in-sourcing their manufacturing needs, this conversation provides timely insights into the complexities and advantages of bringing manufacturing operations closer to home.
Erika and Brendan explore the key considerations manufacturers should take into account when planning in-shoring projects. These include assessing the current state of facilities, identifying necessary upgrades, and understanding the logistical and financial implications of shifting production. The discussion emphasizes the importance of strategic planning and thorough evaluation to ensure that in-shoring initiatives are both feasible and beneficial in the long run.
The episode also highlights the risk-based approach that the FDA is taking for evaluating site inspections. By adopting this approach, manufacturers can better align their operations with regulatory expectations and mitigate potential risks. Brendan shares practical advice on how to prepare for FDA inspections, ensuring that facilities meet the required standards and compliance criteria.
Listeners will gain a comprehensive understanding of the steps involved in updating facilities and the benefits of in-shoring, including improved control over production processes, reduced dependency on international supply chains, and enhanced ability to meet regulatory requirements. This episode is particularly valuable for professionals involved in supply chain management, manufacturing, and regulatory compliance.
Tune in to learn more about the strategic and operational aspects of in-shoring manufacturing needs and how to navigate the associated challenges.