Page 1

Live Webinar

on

Creating Successful Device History Record and keep FDA happy in the process

Date & Time: Wednesday, June 15, 2011

Duration: 60 Minutes

Location: Online

10:00 AM PDT | 01:00 PM EDT

 

Register Now

Instructor: Nancy DuarteLonnroth

Price : $245.00

(for one

Instructor Profile:

participant)

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.

l

How QSIT inspections related to record keeping is performed by FDA. How Change can affect DHRs.

l l l l

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

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

Suggest a Topic

More Webinars

Click here to register for this webinar Your Necessity is our Priority

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

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

About GlobalCompliancePanel GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online compliance training by creating a single window of learning opportunities for compliance professionals & providing a forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training


sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning and development on/through our website. Keep track of all webinars arranged for your industry through notifications & event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for professionals. GlobalCompliancePanel www.globalcompliancepanel.com 1000 N West Street Suite, 1200 Wilmington DE 19801 Phone: 800-447-9407 or Fax your PO to: 302-288-6884 If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe

creating successful device history record and keep fda happy in theprocess  

Overview: Many companies are confident that their record keeping for the firm's device history records is compliant to the Quality System re...

Advertisement