The accreditors of this session require that you periodically check in to verify that you are still attentive.
Please click the button below to indicate that you are.
CASE STUDY 1: 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.
Moderator(s):
Georg
SINGEWALD,
PhD,
SVP, Global Head Engineering, MSAT and Sustainability,
Roche / Genentech
Aditi
S. Thakur,
Senior Pharmaceutical Quality Assessor,
FDA/CDER/OPQ/OPF
You must be logged in and own this session in order to
post comments.