Complimentary webinar: FDA Inspections - Expecting the Expected

Why Should You Attend:

The elements of an FDA inspection are established by the agency and recognized by the regulated industry. The unsaid part is that pharmaceutical and medical devices companies reiterate the inspection process, but fail to maintain controls, track responsibilities and monitor their Quality Systems adequately. Corrective actions implemented may not be effective on account of inability to identify the “true” root cause and appropriate and timely implementation of corrective action plans, effectiveness checks and closures.

The best practices to manage the inspection and establish, monitor and maintain controls of your Quality System are fundamental. Companies need to bear in mind that nothing should fall through the cracks and must ensure that lessons learned are remembered to avoid any re-occurrences by implementing, monitoring and maintaining an effective Quality System as notice for the next FDA inspection might be on its way.

Join this MetricStream hosted webinar with Vanessa Lopez, Regulatory Compliance Expert and Vinay Bapna, Sr. Director of Product Marketing at MetricStream.

Key Discussion Points are:

• Managing FDA’s inspection from Entry to Exit
• The 3I approach of "Implement-Inspect-Incorporate" instead of Retrospect
• Leveraging Technology to be better prepared for FDA inspections

Instructor Profile:

Vanessa Lopez , Sr. Quality, Regulatory and Compliance Consultant. Ms. Lopez has held a wide variety of leadership roles in the Medical Device (Class: I, II, and III), Pharmaceutical (API; Finished Product) and Environmental regulated industries as well as the Consulting Services industry. She has worked for Edwards LifeSciences, Roche Diagnostics, Eli Lilly, Pall LifeSciences, among others. She possesses over 15 years of experience focused on development, implementation, driving improvements and monitoring of Quality Assurance, Quality Control, Regulatory Compliance, Regulatory Affairs, Quality Systems and Supplier Quality activities. Ms. Lopez has in-depth knowledge, coaches on interpretation and application of US regulations, EU directives, specific country regulations (Japan, Canada, and others), national/international standards and guidance documents. She has also held positions within the CAPA, Material, Safety and Management Review Boards as well as represented Quality in Design Control phases.

Vinay Bapna , Sr. Director - Product Marketing, MetricStream.

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