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CASE STUDY 1 - ROUND 2: Practical Applications for OOS Investigations/Assessments


Jun 17, 2021 5:50am ‐ Jun 17, 2021 6:30am


Credits: None available.

Description

CASE STUDY 1 - ROUND 2: Practical Applications for OOS Investigations/Assessments | Background to case-studies that will be addressed: Issues observed included observations of repeat testing until a better and/or passing result is obtained; maximum number of retests NOT specified in SOP; vary based on variability of method and is adjusted during OOS Investigation; multiple attempts of retesting and different definition of “retesting”; disregarding OOS results and failure to thoroughly review unexplained discrepancies; product quality failures are ignored without scientific justification. Testing into Compliance: averaging of failed replicates; finding a flaw in the analysis after the run (e.g., Analyst failure/error/ SST/ QA oversight/ Decision making in QC); failure to extend investigation to other batches.

Speaker(s):

  • Brooke Higgins, Senior Policy Advisor, Office of Manufacturing Quality, Division of Drug Quality, FDA/CDER/OC/OMQ

Moderator(s):

Credits

Credits: None available.

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