Why should you Attend:
FACT: Many Quality Assurance and Quality Control personnel do not understand the FDA move to Systems Based Inspections and are not aware of the types of observations made by FDA investigators. Since one of the focus areas for many inspections is the laboratory, it is important that laboratory personnel understand the FDA system based inspection technique, the systems the FDA will look at when they audit a laboratory, and how the laboratory can prepare for the System Based Inspection.
Since 2001 the FDA has used a system based technique for the inspection of drug and biological production facilities. The systems based technique focuses on the responsibilities of the units within the organization.
This presentation will focus on the responsibilities of the laboratory within the systems based inspection concept and discuss the following:
Areas Covered in the Webinar:
Who Will Benefit:This webinar will help the personnel in the quality control laboratory understand their role in the new FDA focus on Systems. It will also help Quality personnel understand their role in all aspects of the Systems Based Inspections. The following individuals will benefit
Dr. John G. (Jerry) Lanese, PH.D. 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 device component manufacturer. He has lectured throughout the world to clients and for major seminar providers. He was voted the best presenter of the year in 2001 by the Institute of Validation Technology. In 2008 he received the Kenneth Chapman Industry Recognition Award.
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