34th SQA Annual Meeting and Quality College

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.

Description
Fundamental 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?).

Objectives
At 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 Audience
Basic

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.

Description
An effective CAPA process begins with Root Cause Analysis and ends with CAPA Effectiveness. The process requires strategic direction, risk assessment, effective communication, accountability and responsibility agreed and clearly defined. This course will take a deep dive into the CAPA Process; the purpose, effective CAPA creation and how to use the information for fundamental organization change.

Objectives At the end of the course, the participants shall be able to: 

• Understand the value of an organization CAPA Process
• Move from Root Cause identified to corrective and preventative action by:
• Developing a CAPA that addresses the Root Cause (case studies to be provided for hands-on)
• Ensure CAPA is valid and validated
• Effectiveness checking of CAPA via internal audit review
• Systematically implement global CAPA process

Target Audience
Intermediate to advanced. Must have completed the CAPA Problem Definition - Beyond Human Error class or have a solid understanding of Root Cause Analysis.

Agenda

• 8:00 am - 10:00 am
• Review of Problem Definition and Root Cause Analysis
• Group Refresher Root Cause Analysis
• 10:00 am - 10:15 am
• Break
• 10:15 am - 12:00 pm
• The Purpose of a CAPA
• How to Facilitate CAPA Effectiveness
• Group Practice (CAPA Steps 5-6)
• 12:00 pm - 1:00 pm
• Lunch Break
• 1:00 pm -3:00 pm
• Group Practice and Report
• Fundamental Change through Trend Analysis and Process Improvement
• 3:00 pm - 3:15 pm
• Break
• 3:15 pm - 5:00 pm
• CAPA Systems
• Group Scenario - CAPA Systems and Communication
• Q&A