Laboratory Controls - Preparing for a Systems Based Inspection

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:

• 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 Webinar:

• 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, specifically the Quality Control Laboratory
• 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:

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.