Assess Your Laboratory - Based on the FDA System Based Inspection

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

"John G. (Jerry) Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System"

Quality Control Laboratory plays an important part role

Description

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 with applicable regulations and standards.

Why should you attend?

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.

Areas Covered

The following areas will be covered:

  • Standards for the assessment of laboratories
  • FDA System based inspection
  • The audit process – what to look for
  • The audit report
  • Audit follow-up

Who will Benefit

  • Method Development laboratory managers
  • Quality Control laboratory managers
  • Quality Assurance Managers
  • Analytical
  • Method Development chemists
  • Quality Control chemists
  • Internal auditors

Industries who can attend

This 90-minute online course is intended for professionals in the Pharmaceutical, Clinical Data Management SaaS companies, and medical device companies . Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

John G. Lanese

John G. (Jerry) Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan. Since leaving graduate school, Dr. Lanese has had post doctoral research appointments, taught at the college level, filled several Quality Unit positions in the pharmaceutical industry and for the past 15 years he has been an independent consultant, with a focus on the FDA regulated industries. As part of his consulting practice Jerry lectures throughout the world on a variety of topics related to Quality Systems. 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 year by the Journal of GXP Compliance. Recently, in 2007, Jerry received the Kenneth Chapman Industry Recognition Award for his contributions to the Pharmaceutical industry

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