Live Webinar
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FDA 483 Observations in the Laboratory. What went wrong? How can they be avoided?
Date & Time: Tuesday, January 10, 2012
10:00 AM PST | 01:00 PM EST
Duration: 90 Minutes
Instructor: John G. Lanese
Location: Online
Price : $245.00
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(for one participant)
Instructor Profile:
Overview:
John G. Lanese President, Lanese Group, Inc.
In order to proactively address areas of concern to the FDA and other regulators, All units within each pharmaceutical firm should review recent regulatory observations and proactively establish programs or systems to address the regulatory concerns. In this webinar we will focus on the laboratory and recent FDA laboratory based operations. We will review observations, identify the real issue and suggest actions to prevent similar observations in other laboratories.
Areas Covered in the Session: l l l l l l l l
Regulations Inspectional Guidances Laboratory controls Specification, standards, sampling plans, test procedures Conformance to specifications Complete data OOS Following procedures
Click here to register for this webinar Who Will Benefit:
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Director, Quality Control Director, Quality Assurance Manager, Quality Control
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Quality Control Analyst
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John G. (Jerry) Lanese, Ph.D. CMC is the president of The Lanese Group, Inc, an independent consulting service provider that specializes in Quality Systems and Laboratory Controls. Jerry has taught at the college level and worked in various Quality Control and Quality Assurance roles in small and large pharmaceutical firms. For the last 15 years he has consulted in a wide range of projects from consent decree remedial actions with large pharmaceutical firms to systems development for a small component manufacturer. He has lectured throughout the world to clients and for major seminar providers. ...more
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