CAPA Basics: Scope Analysis
We’ve touched on these in the discussion so far but this is a good...
Course Code: ELM-117
by: Don Hurd
Micro-learning
CAPA Basics: ‘Damage Control’ and Containment
Damage Control A nonconformity has occurred so you need to go into “damage control”...
Course Code: ELM-117
by: Don Hurd
Micro-learning
CAPA Basics: Understanding the Problem
Defining the Problem The understanding of the problem is the critical first step in...
Course Code: ELM-117
by: Don Hurd
Micro-learning
CAPA Basics: Prioritizing Based on Risk
Prioritizing Based on Risk You probably already practice this but maybe don’t realize it....
Course Code: ELM-117
by: Don Hurd
Micro-learning
Sources of Corrective and Preventative Actions
We talked about CAPAs arising from both product and process.  Let’s point out just...
Course Code: ELM-117
by: Don Hurd
Micro-learning
CAPA Basics | Process Requirements: ISO 13485
As noted previously, ISO defines separate processes for CA and PA. ISO 13485 CA...
Course Code: ELM-117
by: Don Hurd
Micro-learning
CAPA Basics | Process Requirements: FDA
As mentioned previously, the FDA considers the CAPA system a ‘single’ system.  The process...
Course Code: ELM-117
by: Don Hurd
Micro-learning
CAPA Basics: Process Requirements Overview
Let’s take a quick look at what the regulations require. Documented Procudures First, a...
Course Code: ELM-117
by: Don Hurd
Micro-learning
CAPA Basics: Industry Non-Compliance
Noncompliance in the CAPA system is the leading area for findings in FDA inspections. ...
Course Code: ELM-117
by: Don Hurd
Micro-learning
CAPA | Systemic Issues: Process Examples
As noted earlier, issues can arise in areas other than just the product. Here...
Course Code: ELM-117
by: Don Hurd
Micro-learning