RQAP re-registration units: 2 GCP, GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.
DescriptionFundamental to an effective CAPA program is the practical application of Root Cause Analysis (RCA) and developing an understanding of the root cause(s), contributing cause(s), and possible cause(s) of the issue/problem. Defining the problem - setting boundaries - is integral to enabling an effective RCA. This course will provide tools, insight and best practice to support continuous process improvement and enable sustained results by emphasizing approaches to defining the problem and analyzing the causal factors. A common deficiency in many Industry CAPA programs is a myopic RCA identifying human error and solely prescribing training as the preventive mitigation. By going beyond human error and training, the effective CAPA program becomes a systematic assessment, focusing less on the individual and more on the process(es) in place (What about the process that allowed the issue to occur?) and the process quality control (What about the process that allowed the issue not to be detected?).
ObjectivesAt the end of the course, the participants shall be able to:
- Understand the difference between reactive and proactive
- Understand the advantage of a systematic methodology
- Know what is CAPA?
- Define a problem (case studies to be provided for hands-on)
- Understanding high level process mapping
- Apply root cause analysis, including process tools (fishbone/is-is not/5 Whys)
- Develop corrective action that addresses the Root Cause
Target AudienceBasic
