CAPA Training Course

Overview

There are numerous requirements for implementing a CAPA (Corrective & Preventive Actions). FDA Warning Letters frequently describe compliance issues relating to CAPA systems and implementation of Corrective & Preventive Actions, from a lack of adequate root cause investigations and analysis through inadequate follow-up checks to delayed closing of CAPAs.

How many times has the root cause of an issue been attributed to “human error” and the corrective action implemented was “re-training”? Clearly one too many times, hence why the regulations have been updated to specifically state “Where human error is suspected or identified as the cause, this should be justified having taken care to ensure that process, procedural or system based errors or problems have not been overlooked, if present.” (PIC/S  GMP Guide)

Don’t leave yourself open for another “poor investigation” audit finding regarding your CAPA system.

Join our expert PharmOut cGMP trainers, who have an unhealthy passion regarding CAPA processes, to hone your knowledge and skills for implementing an effective CAPA system and procedures!

During this CAPA Training Course, our cGMP trainers will provide practical tools and techniques to identify issues, investigate and determine root causes, properly implement corrective and/or preventive actions, and to conduct CAPA effectiveness checks.

What you will learn in our intensive CAPA training course.

The 1-day intensive CAPA training course will provide participants with an understanding of:

• CAPA and life sciences regulations including ICH Q10
• Issue Identification
• Problem Investigation – Root Cause Analysis (RCA)
• Use of RCA Tools
• An effective CAPA process
• Documenting CAPA
• Developing CAPA systems
• CAPA and continuous improvements

Course format

The course is a combination of lecture-style learning and active workshops, with participants working in small groups on assigned tasks and case studies. This course may be available in a virtual format (Via ZOOM) or as a public course.
Or contact us to discuss options for onsite CAPA training for large groups of cGMP personnel.

Course materials

Participants will receive a copy of the presentation(s), relevant notes and workshop materials.

A Certificate of Completion (cGMP compliant record) will be issued to participants who successfully complete the CAPA course Final Assessment.

Assessment

An online assessment is conducted at the end of the course.

Who should attend?

• Quality Assurance personnel
• Quality Control personnel
• Operations and Manufacturing personnel
• Qualification & Validation personnel
• Engineering and Automation personnel
• IT personnel
• Anyone within the GMP industry interested in learning about or improving their knowledge of CAPA.
  zPrice

Register

Register for a CAPA Training Course below:
If you need any assistance in booking or would like a quote for personalised training at your site, please do not hesitate to contact us at one of our offices around the world.