Laboratory Controls - Preparing for a Systems Based Inspection

This training on laboratory controls will focus on the systems within a laboratory that will be audited by an FDA investigator using the systems based inspection approach. You will understand the FDA focus on systems and how you might improve procedures in your laboratory to be better prepared for a regulatory agency inspection.

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.