BIOTECHNOLOGY 2013 - The US FDA Quality System Regulation (QSR) ? What Every Executive and Senior Manager Must Know

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Category BIOTECHNOLOGY 2013

Deadline: May 09, 2013 | Date: May 09, 2013

Venue/Country: Online, U.S.A

Updated: 2013-05-03 17:32:03 (GMT+9)

Call For Papers - CFP

FDA expects that the executive and senior management team understand their responsibilities as set by the QSR. This training solution provides an effective and cost effective way to provide such training.

This Webinar provides an overview of the requirements of all Subparts of the QSR with specific emphasis on the responsibilities of executive and senior management.

Learning Objectives

After watching this interactive Webinar, you will understand the answers to the following questions:

? What is the Quality System Regulation and why do I need to understand its requirements?

? What is a “quality system” and what role do I play in it as a member of executive or senior management?

? What are each of the QSR Subparts and how do each of them affect my team’s everyday actions?

? What specific responsibilities do executive and senior management have as set by the QSR and what is the potential impact to the organization if these responsibilities are not fulfilled?

? What personal culpability do I have as a member of the executive or senior management team?

What is the most common violative condition cited by FDA in Warning Letters and how does our organization avoid such enforcement action?

Who Will Benefit

This webinar is essential for the executive and senior management team of your Medical Device Company.

Job functions:

This training solution provides a specific review of the requirements of the US FDA QSR that the executive and senior managers of every department need to know.

About Speaker

Michael has over thirty years of experience in the medical device, pharmaceutical, human tissue and biotechnology industries and has held the senior quality assurance position in both start-up and large multi-national corporations, specializing in difficult turnaround situations. Michael has expertise in a wide variety of product and manufacturing technologies and is a recognized expert in quality systems, risk management, software and process validation, and continuous improvement methods. He lectures worldwide for various trade groups.

Barile & Associates is a consulting firm comprised of a group of over forty senior quality, regulatory, operations and manufacturing professionals and provides a broad range of support to the medical device, pharmaceutical, human tissue and biotechnology industries. The firm has capabilities in design and manufacturing engineering, science, statistics, quality systems, process design and validation, computer technology deployment and validation, quality/regulatory crises management and are experts in US FDA and international regulatory requirements

Speaker : Michael Barile

Product ID : F62306

Schedule Date :

Thursday, May 09, 2013

duration : 01:00 to 02:30 PM EDT

https://compliance2go.com/index.php?option=com_training&speakerkey=46&productKey=243