7 Steps to Respond to an FDA 483 Inspection Observation

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Timestamps
0:00 Screen is black / Audio Only
0:46 Video begins
0:59 Step 1 Respond in 15 days
3:38 FDA may be late
5:15 Step 2 Use your CAPA form
8:19 Key elements of CAPA forms
9:26 8D Process
12:40 Step 3 How to document Root Cause Investigation
14:58 Root Cause Analysis Tools
16:14 5 Why Analysis
18:55 Corrective & Preventive
20:54 Step 4 Don't forget correction & containment
23:41 Correction vs Corrective Action
24:07 Containment
25:57 CDRH Recall Regulations
26:35 Recall Classification
27:17 Guidance from FDA
29:08 Step 5 Corrective Action Plans
30:08 Corrective Action
30:44 Step 6 Show you have already taken action
34:24 Step 7 Follow-up before the FDA
36:25 Documentation
38:22 Effectiveness Checks
41:37 Trend Analysis
42:38 Re-Audit for Effectiveness