Assess Your Laboratory - Based on the FDA System Based Inspect
Date : 31 January 2019
Time : 02 : 00 PM EST
Duration : 90 MINUTES

John G. (Jerry) Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System. He lectures throughout the world and presents webinars on a variety of topics related to Quality Systems, GMPs, APIs, laboratory operations, calibration, change control, deviations and product reviews for clients and seminar, webinar and conference providers. He was named the Best Seminar Presenter of the year 2001 by the Institute of Validation Technology. In 2005, his article “Training and the Laboratories” was selected as best article of the year by the Journal of GXP Compliance. In 2007, Jerry received the Kenneth Chapman Industry Recognition Award for his contributions to the Pharmaceutical industry.

The Quality Control Laboratory plays an important part role in the production and release of a drug product regulated by the FDA. Inspectional observations of non-compliant laboratory operations are high on the list of most frequent regulatory observations. As the industry focuses more on the quality system, quality metrics, and product and test method lifecycle, the operation of the laboratory unit becomes more visible. The organization should have active programs in which the laboratory is routinely assessed for compliance to applicable regulations and standards 

Prior to the 1990s, FDA investigators did not spend much time the quality control laboratory. However, shortly before the turn of the century, the FDA realized that many laboratories were not adequately investigating out-of-specification (OOS) results. This brought more visibility to the laboratories and today, FDA observations in the laboratory are among the most frequent observations made during an FDA inspection. It is appropriate that the quality control laboratory, or an audit group within the organization, proactively audit the laboratory to assure compliance of laboratory operations. This webinar is intended to provide guidance on areas to audit and potential non-compliances to look for.

Learning Objectives

Quality Control Laboratories have been an important part of inspections since the mid-1980s. These laboratories are generally staffed by highly educated and trained personnel and equipped with sophisticated instrumentation. Inspections include scrutiny of method validations typically performed by the Method Development Laboratory. In order to the meet regulatory requirements and have appropriate internal controls the, laboratories must implement training and laboratory control systems which are defined in extensive procedures. The organization and the laboratory should have proactive programs which provide assurance that the laboratory is continually in compliance with regulations and internal procedures. The objective of this webinar is to identify areas that should be reviewed in an assessment of the laboratory.

Who Should Attend

  • Method Development laboratory managers
  • Quality Control laboratory managers
  • Quality Assurance Managers
  • Analytical
  • Method Development chemists
  • Quality Control chemists
  • Internal auditors  - Working in: Branded and generic pharmaceutical firms, Contract manufacturers, Contract testing laboratories.
  • $179.00