Date : Wednesday, June 22, 2011 Time : 10:00 AM PDT | 01:00 PM EDT Duration : 60 Minutes Price : $245.00
Live Webinar What to Expect and How to Prepare for FDA Inspections
Overview: As recent headlines demonstrate, non-compliance with US Food & Drug Administration US FDA laws and regulations could cost your firm millions.
Register Now Instructor Profile:
In addition to significant revenue losses, violative US FDA inspections may also lead to injunctions, consent decrees, warning letters, FDA 483 's Notice of Inspectional Observations, product non-approvals, import detentions, recalls, criminal investigations and prosecutions, seizures, compliance problems, FDA compliance meetings, and monetary penalties. Areas Covered in the Session: l l
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How to handle an inspector Key do's and don’ts: things that will kill you during an inspection How to train your employees and management for an FDA inspection ¡ What can you expect from an FDA Inspection ¡ How does the FDA train the people inspecting our company? ¡ What guidance and procedures do the people inspecting us follow? ¡ What types of companies does the FDA inspection ¡ What laws and regulations form the basis of an FDA inspection ¡ What laws and regulations will our company be inspected to ¡ What are the different types of inspections ¡ What are the first stages of an FDA inspection ¡ Who should be present during an FDA inspection ¡ How should people behave during an FDA inspection ¡ Should our company have an SOP for FDA inspection ¡ Is there anything the FDA is not eligible to see ¡ What areas will the FDA inspect ¡ What is the FDA's Inspectional Approach ¡ What do they look for during a walkthrough ¡ What records will the FDA inspect ¡ How does FDA document it's findings or inspectional observations ¡ How does FDA have to support it's findings or inspectional observations ¡ What information can the FDA request during an inspection ¡ What areas can the FDA request to see during an inspection ¡ Who can the FDA talk to during an inspection ¡ What inspectional tools and investigative techniques do the FDA use ¡ What is on an FDA-483 ¡ FDA inspection objectives. ¡ FDA's 21st-century initiatives and their impact on inspections Quality Systems Approaches and Inspections Risk Management Electronic records/electronic signatures (21CFR11) The approval process and how inspections are planned and triggered The differences between a GMP and a pre-approval inspection (PAI) ¡ Strategies of companies that have been successful; Lessons from companies that have failed ¡ Recognize the traps and pitfalls facing you in an inspection ¡ Know why you pass or fail an inspection in the first fifteen minutes ¡ Understand why you absolutely cannot afford to fail an FDA inspection
Nancy Duarte-Lonnroth Director, Quality and Regulatory Affairs, Celestica Nancy, is the Director of Quality & Regulatory Affairs, Healthcare responsible for global coordination of Celestica's Healthcare Quality, Regulatory and FDA compliance. Nancy is Quality and Regulatory expert with fifteen years experience in regulatory affairs, quality systems, compliance, clinical quality, validation, auditing, quality control, data management systems, post market surveillance, supplier management and regulatory compliance in the areas of bio/pharmaceuticals, medical devices and combination products. Nancy has contributed to the success of both venture and public companies, establishing a track record of successfully achieving timely global regulatory approvals, initiating and effectively managing preclinical and clinical investigations and developing and maintaining effective and compliant quality systems in various healthcare sectors. ...more
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Your Necessity is our Priority
Click here to register for this webinar Who Will Benefit: l l
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Senior Management who will deal with FDA inspectors Regulatory Affairs Professionals and Quality Assurance Personnel Production Engineering Validation Quality control and research and development staff who will be facing an FDA inspector will find this seminar essential preparation and key to the company’s success at the inspection.
It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel
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