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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

Regulating Cannabis

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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