Attend this course to learn the rationale, strategies and flow on how to plan for an FDA inspection, the inspection process and approach, and which company roles should be assigned for these types of inspections, among other related topics.
This is a detailed course designed to provide pharmaceutical professionals with the information they require to prepare for and manage FDA inspections. 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 regulated products and activities, 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 regulated product and activities 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 cGMP/Quality System as notice for the next FDA inspection might be on its way.
This course provides the rationale, strategies and flow on how to plan for an inspection, the inspection process and approach, and which company roles should be assigned for these types of inspections, among other related topics.Learning Objectives:
The webinar will furnish details on the following topics:
Sr Quality Regulatory Consultant, Quality and Regulatory Consulting Services
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 25 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.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
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