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Live Webinar on :

Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) - Regulatory Documents Explained

Wednesday, June 27, 2012 duration : 01:00 to 02:00 PM EDT

Many citations by FDA and notified bodies include findings with respect to insufficient information in the Design History File, not following the procedures to make the device as established in the DMR and incomplete or inaccurate production data of incoming, in-process and finished products. Is your company able to access all relevant documents detailing the design of your device? Is your DMR accurate and is it being followed? Can the operators access your DMR? Are you recording and documenting all your production and testing data and maintaining them in the DHR?

Get 15 % Discount as a early bird registrations. Use Promo Key : CGO15

Areas Covered in the Session:

DMR and outsourced design/production DMR and OEM relationships Controlling and maintaining DMR Device History Record (DHR) Definition Contents Using DHR data for tracking and trending DHR and outsourced design/production DHR and OEM relationships Technical File (TF) Definition Contents TF and outsourced design/production TF and OEM relationship Design/process changes and DHF, DMR, DHR, and TF


Live ( Single registration ) : $189.00 Group ( Max 10 Attendee): $249.00 On Demand (Recording available):$289

Get Training CD : $399

Who will benefit

This Webinar is designed for people involved in document preparation and maintenance, and those who have involvement with documentation. This typically includes: Quality Managers/Engineers Production/Process Managers/Engineers Manufacturing Managers/Engineers QA and QC managers, inspectors, supervisors and personnel Documentation Specialists Supplier Quality Managers/Engineers

About Speaker
Dr. Linda Yang, was until recently Associate Director, Regulatory Affairs for a pharmaceutical company. Currently as an independent consultant, she provides directions for regulatory strategy, regulatory submission, clinical studies, CMC requirements for different development stages, product indications, and labelling. She has spent last 19 years working for pharmaceutical companies and is an expert in regulatory and quality compliance. She has broad background and played leadership role in functional areas such as product development, business process optimization, quality compliance, clinical development, and regulatory strategy. She had hands on experience on global regulatory management and submission. She has experience working with US, European and other global regulatory regulations. She co-authored the book of the Fundamentals of US Regulatory Affairs (2009). Dr. Yang currently teaches regulatory affairs and compliance for University of Berkeley Extension, and regulatory and pharmaceutical development for Pharmaceutical Training Institute (PTI). Dr. Yang obtained her Ph.D in 1992; MBA in 2004; Certifications of Regulatory Affairs (RAC) and Quality Auditor (CQA) in 2009.
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