Laboratory Controls - Preparing for a Systems Based Inspection


Instructor: John G Lanese
Product ID: 701309
Training Level: Intermediate

  • Duration: 90 Min
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.
Last Recorded Date: Mar-2013


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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.

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Refund Policy

Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).




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