BIOTECHNOLOGY 2013 - Complaint Systems ? The Essential Requirements

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Category BIOTECHNOLOGY 2013

Deadline: May 22, 2013 | Date: May 22, 2013

Venue/Country: Online, U.S.A

Updated: 2013-05-03 17:48:27 (GMT+9)

Call For Papers - CFP

Complaint Systems have come under intense scrutiny by the FDA in recent years. This course will examine the current industry/FDA environment and will give you tools for survival; it will provide a step-by-step guide to the essential requirements of a Complaint System including setting-up, operating, and managing the system for today’s FDA regulated industry environment. Further, this course provides “content understanding” so important when auditing Complaint Systems.

Section 1: Background-Regulatory Requirements

? Key Definitions: what is a complaint, anyway?

? What needs to be in my complaint procedure?

Section 2: Complaint Receipt

? Complaint Review: Is it an Adverse Event?

? Complaint Investigations; so, why did it fail anyway?

Section 3:

? Do I need to take Corrective Action?

? Can I close this complaint already?

? What is Complaint Trending and why do I need to do it?

? Resources, Record-keeping, and other Essentials

Who Will Benefit

This webinar will benefit professionals in the following industries:

? Medical Device,

? Pharmaceutical,

? Human Tissue,

? Biotechnology

In departments such as:

? QA/QC/RA,

? Manufacturing/Operations,

? Research and Development,

? Legal

With job functions:

? Department Managers and Supervisors,

? QA/QC/RA Specialists and Engineers,

? Manufacturing and R&D Engineers,

? Chemists, Scientists, Formulators,

? Documentation Specialists,

? Auditors,

? Technicians

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 : C62305

Schedule Date :

Wednesday, May 22, 2013

duration : 01:00 to 02:30 PM EDT

https://compliance2go.com/index.php?option=com_training&speakerkey=46&productKey=241