Avoid FDA 483 Observations Through Effective Investigation And CAPA Procedures

Event Information
Product Format
Prerecorded Event
90 Minutes
Product Description

Learn How to Avoid Warning Letter and 483 Observations with Effective Investigations

Inadequate investigations are one of the most cited observations in FDA 483s and warning letters.  The FDA and other international regulators are placing great emphasis on complete and timely investigations with follow-up.

Recent Consent Decrees have included requirements that the firm develop and implement, systems that result in timely and complete investigations of deviations, which include root cause analysis and corrective and preventive actions. FDA 483 and warning letter observations identify inadequate investigations and follow-up.

In this session, speaker Dr. John G. (Jerry) Lanese, will address the adequate investigation of deviations and provide insights on effective investigations and ways to identify the root cause, to prevent similar deviations in the future.

The timely investigation of deviations with appropriate corrective and preventive action is clearly a US FDA and other regulatory bodies’ expectation. The international regulatory expectation for a structured approach to investigations that lead to corrective actions and preventive actions is clearly stated in ICH Q10, pharmaceutical quality system, supported in the FDA’s guidance to the industry and quality system approach to pharmaceutical CGMP regulations.

In this 90 minute audio session, John will discuss about the deviation system, the relationship with investigations and the CAPA system, what should be investigated and the level of investigation. Plus, he will discuss and analyze several tools that will lead to the identification of the root cause, and the recent FDA 483 and warning letter observations to identify areas where an organization can improve.

Areas Covered in the Session:

  • FDA expectations for investigations and observations.
  • Deviations
  • Investigations
  • CAPA
  • The investigation/problem resolution process
    • Understand the problem
    • Identify possible causes
    • Data collection
    • Data analysis
    • Root cause identification
    • Root cause elimination
    • Solution implementation
    • Verify success.
  • Tools for problem solving
  • Corrective action.
  • Preventive Action.
  • Verification.
  • Relationship of the systems
  • What is timely

Who should attend?

  • Senior Management
  • QA document reviewers
  • QA personnel responsible for reviewing investigations reports
  • QA personnel responsible for the deviation and investigations systems
  • Quality and Operations personnel responsible for investigations
  • Personnel from all units responsible for initiating investigations
  • Target Companies: For marketing (Examples)
  • Small and large branded and generic pharmaceutical companies
  • Contract Research organizations
  • Suppliers
  • Target Association/Societies

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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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