Design History File (DHF), the Device Master Record (DMR) and the Device History Record (DHR) - Principles of Lean Documents and Lean Configuration

By: José Mora ,Principal Consultant.

Theory of Lean Documents and also formulates a corresponding Theory

  • 28-September-2018| 03:00 PM ET | 12:00 PM PT | 02:00 PM CT Duration 90 Minutes

Manufacturing and Marketing OTC Drugs in Compliance with FDA Regulations

By: Dr. Loren Gelber ,Pharmaceutical consultant.

OTC drug product for marketing

  • 09-October-2018| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

The Use of EHR Data in Clinical Investigations (Research) – FDA’s Latest Guidance

By: Richard Chamberlain ,Owner at Extended Clinical Services, LLC.

EHR system in a submission to FDA

  • 25-October-2018| 01:30 PM ET | 10:30 AM PT | 12:30 PM CT Duration 90 Minutes
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