Creating Successful Device History Record and keep FDA happy in the process
Date & Time: Wednesday, June 15, 2011
Duration: 60 Minutes
10:00 AM PDT | 01:00 PM EDT
Instructor: Nancy DuarteLonnroth
Price : $245.00
Nancy Duarte-Lonnroth Director, Quality and Regulatory Affairs, Celestica
Overview: Overview: Many companies are confident that their record keeping for the firm's device history records is compliant to the Quality System regulation, yet when the FDA comes calling, FDA 483 DHR cites are written and warning letters, seizures or worse ensue.
Learning Objectives: l
Learn what FDA expects and will request from you during your DHR review.
How QSIT inspections related to record keeping is performed by FDA. How Change can affect DHRs.
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Learn what constitutes a good DHR procedure. Learn how risk management fits into DHR compliance. Learn how to better audit quality record systems.
Areas Covered in the Session: l l l l l l
Introduction Guidance documents/ QS regulation Major FDA 483 points Trends in FDA warning letters Determining best practice for the DHR audit Be prepared by knowing how to conduct a MORE thorough record audit FDA 483 point issuance prevention
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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Who Will Benefit: l l l l l l l l
Senior executives of pharmaceutical and device firms Quality Unit Vice Presidents Directors and Managers
Vice presidents Directors and Managers of operations Quality Engineers and field Auditors Regulatory and Compliance Management Consultants
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