Planning is the key to success, and this holds true for FDA inspections as well. In this must-watch video, our expert, Melissa Schneider, Associate Director of Compliance at Compliance Insight (www.compliance...), reveals valuable insights on how to plan and prepare for FDA inspections, whether they are surprise or scheduled.
Melissa emphasizes the importance of being inspection-ready at all times and shares essential strategies to achieve this. From developing a robust internal audit program to maintaining up-to-date documentation and common inspection items, she provides actionable tips for being organized and prepared.
Additionally, Melissa discusses additional steps for scheduled inspections, such as reaching out to inspectors for information and creating a tailored preparation plan based on the audit agenda.
Don't miss out on these expert recommendations to ensure a smooth and successful FDA inspection experience.
Watch the full interview with Melissa here: • FDA Inspection: Prepar...
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For more, visit us at www.compliance...
Compliance Insight is a leading FDA regulatory and quality assurance consulting firm that offers a range of services to assist companies in navigating the complexities of FDA regulations. With their in-depth knowledge and expertise, Compliance Insight provides invaluable guidance and support to ensure compliance with FDA requirements.
One of their key services is assisting companies with the 510(k) process. They understand the intricacies involved in preparing and submitting 510(k) applications for medical devices. Compliance Insight helps clients gather the necessary data, conduct thorough reviews, and ensure the application meets all regulatory standards, streamlining the path to FDA clearance.
In addition, Compliance Insight has extensive experience in the emerging field of cell and gene therapies. They offer specialized guidance on navigating the unique regulatory landscape for these innovative therapies, helping clients understand and meet FDA requirements to bring their life-changing treatments to market.
Another area of expertise for Compliance Insight is providing assistance with 483 and Warning Letter response and remediation. In the event of an FDA inspection resulting in observations or deficiencies (captured in Form 483), Compliance Insight supports companies in developing comprehensive and effective responses. Their team works closely with clients to address each observation, develop appropriate corrective actions, and ensure timely and compliant resolution.
Whether it's navigating the 510(k) process, advancing cell and gene therapies, addressing 483 observations, product recalls, or more; Compliance Insight's services encompass comprehensive regulatory support to help companies achieve and maintain FDA compliance, fostering successful product development and market approval.
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