Compliance in the Laboratory – Understanding Current FDA, ICH and USP Requirements

Event Information
Product Format
Prerecorded Event
Conference Date
Tue, Jan 17, 2017
90 minutes
Product Description

Non-conformance to the Laboratory Standards Often Observed by FDA: How to be Compliant and Proactive to Prevent Such Observations

Many FDA inspections include an in-depth assessment of laboratory operations and investigators have made significant observations of non-conformance to the GMPs in the laboratory during site inspections.  Laboratory personnel should be aware areas of non-compliance observed by investigators and proactively implement systems that will prevent similar observations in their laboratory.

Recent FDA investigations have resulted in observations covering inadequate investigations of Out-of-specification results, inadequate testing of incoming materials, data integrity, not following procedures and other non-conformances with GMPs. All laboratory staff should be aware of the parts of the GMPs that apply to the laboratories and areas in the laboratory the agency is most concerned about and proactively implement systems that will help the laboratory avoid FDA observations.

This audio session by expert speaker John G. (Jerry) Lanese will provide the personnel in the quality control laboratory an understanding of their role in maintaining a compliant laboratory operation. It will also provide laboratory managers and auditors of Quality Control laboratories areas to review to assure compliance. Discussions in this session will be based on non-conformances most often cited by the FDA and the pertinent regulation.

Session Highlights:

  • FDA 483 observations in the laboratory with analysis and preventive actions.
  • Specific observations that relate to the laboratory cited in Warning Letters and FDA 483s.
  • An analysis of what went wrong.
  • Overview of systems, procedures and records the laboratory should have in place that would prevent a similar observation.
  • Learn about the several questions that a laboratory manager or an auditor might ask to assure that appropriate systems, procedures and records are in place and being followed.
  • Responsibilities of laboratory analysts, supervisors and managers.
  • Laboratory records.
  • Laboratory procedures.
  • The importance of following procedures.
  • The importance of adequate deviation investigations.

Who Should Attend

  • Personnel who have responsibilities in laboratory operations, including Directors, managers and line personnel.
  • QA directors, managers and those involved with, deviation investigations and Training.
  • Personnel in analytical development laboratories..
  • Personnel involved with the testing of all dosage forms

At the Q&A session following the live event, ask a question and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Dr. Jerry Lanese - Pharma Guidelines Expert

Dr. 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 and began his career teaching Analytical Chemistry in a small liberal arts college. Dr. Lanese moved from the academic environment to the pharmaceutical industry where...   More Info
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