Approaching Unknown Cause Laboratory Investigations Using Lean Tools – Webinar –

DUBLIN–()–The “Approaching
Unknown Cause Laboratory Investigations Using Lean Tools”

webinar has been added to’s

Understand the requirements for investigations when dealing with
pharmaceutical drug substances and products; to understand how to
effectively control and conduct a laboratory investigation for unknown

Why Should You Attend:

When an out of specification or out of trend result is obtained on an
active pharmaceutical ingredient or a pharmaceutical product, both ICH
and CFR guidance indicates a need for investigation. At times, the root
cause is easily identified and the investigation is conducted swiftly.
However, when the root cause cannot be easily accessed by initial
review, it can be frustrating to determine the appropriate path for the

The recent movement of bringing lean and six sigma projects into
industry has had a surprising positive side effect. The tools of lean
assessment of issues and problems are also excellent tools to conduct
laboratory investigations. This training will give guidance on how to
break open an issue and will demonstrate the use of some tools for
evaluating problem spots. It will also demonstrate how lean tools can
aid in establishing as well as controlling the breadth of an

Areas Covered in the Webinar:

  • ICH guidelines for investigations.
  • 21 CFR 210 & 211 requirements for investigations.
  • Relevant lean tools.
  • Initiation of an investigation.
  • Controlling the scope of an investigation.
  • Finding acceptable resolution.
  • CAPAs.

Who Should Attend:

This webinar will provide valuable assistance to all personnel

  • QC functions in general
  • QC testing groups
  • QC investigation groups
  • QA reviewers and investigators
  • Manufacturing personnel who support investigations
  • Management teams who need to understand investigational pathways

For more information about this webinar visit

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