CAPA Training Course
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 PE009-13)
Join Maria Mylonas, PharmOut’s Learning & Development Director, who has an unhealthy passion regarding CAPA processes! During this CAPA Training Course Maria will provide you with the practical tools and techniques on how to identify issues, investigate to determine root cause, implement corrective and/or preventive actions and conduct effectiveness checks. Don’t leave yourself open for another “poor investigation” audit finding.
What you will learn
The 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
The course is a combination of lecture-style learning and active workshops, with participants working in small groups on assigned tasks and case studies.
Participants will receive a copy of the presentation(s), relevant notes and workshop materials. A certificate of completion will be issued to participants who successfully complete the assessment.
A written 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.
AUD $450.00 + 10% GST
Prices are per person and include morning tea, lunch and afternoon tea
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.
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