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System Based Inspections - Laboratory Controls This 90-minute training on the FDA system based inspection technique will focus on the responsibilities of the laboratory within the systems based inspection approach and will help the personnel in the quality control laboratory understand their role in the new FDA focus on Systems.

Description FACT: Many organizations do not understand the FDA move to Systems Based Inspections. One of the focus areas for many inspections is the laboratory and it is important that laboratory personnel understand the FDA system based inspection technique and the type of things the FDA will look at when they decide to investigate the Laboratory Control System, what are the responsibilities of the 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. Although the Quality unit and the Quality System are always a part of the inspection, the system based technique focuses on the responsibilities of other units within the organization. This discussion focuses on the responsibilities of the laboratory within the systems based inspection concept and discusses: What constitutes the Laboratory Control System. The responsibilities of the Quality Control Laboratory. Responsibilities of the Quality unit. FDA 483 citations that have resulted from deficiencies in the Quality Control Laboratory and an analysis of the cause. The impact of the systems concept on the organization. Areas Covered in the Seminar: What is a Systems Based Inspection. Why FDA moved to Systems Based Inspections. What is different from the old inspectional techniques. What is the Laboratory Control System. Has the new technique changes the findings? What are the responsibilities of the various units in the organization. What are the specific things the FDA is looking at. What other changes can be anticipated in FDA inspections.


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 Personnel who have responsibilities in laboratory operations, including Directors, managers and line personnel. QA directors, managers and those involved with Change Control, deviation investigations and Training. Personnel in analytical development developing new methods. Validation specialists. Personnel involved with the testing of all dosage forms.

Instructor Profile: 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. 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.

FDA system based inspection techniques focus on the laboratory controls  

FDA system based technique used for the inspection of drug and biological production and focuses on the responsibilities of various units wi...