Beginners Guide to TikTok for Search - Rachel Pearson - We are Tilt __ Bright...
CAPA and CAPA
1. CAPA versus CAPA
Bryan J. Kelly, RAC, FRSC
Bryan J. Kelly 3/24/2012 1
2. CAPA versus CAPA
Bryan J. Kelly, RAC, FRSC
Biography: Twenty-Five years of experience in FDA
regulated industries, Medical
Device, Pharmaceuticals, Diagnostics. Numerous
roles: Laboratory Manager, Quality Assurance
Director, Regulatory Affairs Professional, Validation
Professional, Auditor, Complaints Manager…
Bryan J. Kelly 3/24/2012 2
3. CAPA versus CAPA
It is ‘generally’ true to state:
• In Medical Device Regulations Corrective and
Preventive Actions requirements are defined in 21
CFR 820.100
• In Pharmaceutical cGMPs - CAPA principles are
more generally and vaguely identified as part of
Production Record Review or 21 CFR 211.192
Bryan J. Kelly 3/24/2012 3
4. CAPA versus CAPA
So a question for RA/QA professionals:
Is it really ‘righteous’ for FDA Inspectors to issue
SPECIFIC CAPA observations to a Pharmaceutical
Corporation under the legal mandates of what is
actually stated in 21 CFR 211…
Bryan J. Kelly 3/24/2012 4