Failure Investigation CONTENT Package

"Your firm has not thoroughly investigated the failure of a batch or any of its components to meet its specifications whether or not the batch has already been distributed  [21 C.F.R. § 211.192]" is a citation we see over and over again in FDA Warning Letters. This package will provide guidance to help meet specific FDA Requirements.

➢ 1. The Seven Deadly Sins of Failure Investigations (One Hour Webinar Recording)

➢ 2. The Seven Deadly Sins of Failure Investigations (PowerPoint Training Presentation)

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➢ 3. Failure Investigation and CAPA Implementation FORM

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➢ 4. Failure Investigation Audit Checklist

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1. and 2. The Seven Deadly Sins of Failure Investigations (One Hour Webinar Recording and PowerPoint Training Presentation)

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In this webinar the following is reviewed: Basic GXP requirements for failure investigations, including out-of-specification, manufacturing, complaint, and other investigations. Compare and contrast a GXP failure investigation with that taken by a CSI (Crime Scene Investigator) team."Seven Deadly Sins" for failure investigations - those seven items appearing repeatedly in recent FDA Warning Letters impacting failure investigations. Actions that could prevent deficiencies. Potential future "hot topics" relating to failure investigations that will likely appear with increasing frequency related to FDA enforcement.

3. Failure Investigation and CAPA Implementation FORM

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This five page document includes the following areas; issue description, investigation summary, analysis of investigation data and identification or root cause, impact on company systems and processes and much more.

4. Failure Investigation Audit Checklist

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This comprehensive audit checklist includes 39 items one must consider when conducting an effective failure investigations. Areas covered include the following: basic elements of an effective failure investigation program, conducting the investigation and investigation conclusions, rationale and close-out.

Failure Investigation CONTENT Package is only $99.00 -