"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"
Effective Corrective Action and Preventive Action
– for Medical Device Industry
This course provides you with the knowledge and confidence to interpret the Corrective and Preventive Action requirements in ISO 13485:2016 and the US Food & Drug Administration’s Quality System Regulation.
Over two days, you will learn the key requirements for medical device Corrective Action and Preventive Action (CAPA), explore key concepts, and consider options for implementing effective CAPA.
- Review and discuss ISO 13485:2016’s and FDA’s Corrective and Preventive Action requirements.
- Identify key aspects of an effective CAPA process.
- Compare investigation approaches, and resulting action planning and implementation.
- Evaluate options for determining effectiveness of CAPAs.
- Understand how CAPA fits in the Quality Management System.
- Explore typical auditor questions and intent regarding CAPA.
- Purpose of a CAPA system
- Identifying issues proactively
- Reactive issue identification
- Corrections vs Corrective Actions
- CAPA process for addressing issues
- Conducting investigations to identify root causes
- Action planning for success
- Confirming CAPA effectivity
- Relationships in the QMS: Complaint Handling & Nonconforming Product
- CAPA Records
- Key considerations for a successful audit
Note: This course is presented electronically. Each attendee must bring their own laptop to the course venue; course materials are provided electronically, and Adobe PDF Reader is essential to fully participate in the course.
Who should attend:
Intended for professionals with some knowledge of medical device or combination product Quality Management Systems. This course is ideally suited to staff needing a broad perspective on CAPA, including Research & Development, Engineering, Manufacturing, Quality, Regulatory, and internal quality auditors.
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Medical Device industry
US and Global
Ms. Tammy M. Pelnik,
St. Vrain Group, Inc.
Date, location and venue:
This course is only offered in-house.
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