"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.
When attending a Key2Compliance® course, you get access to Gate2GMP®, our document library and search tool.
At Gate2GMP® each course has its own page where you can download course materials, receive up to date information and communicate in the course forum.
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Bring this course in-house?
Are you a group in need of the same training?
Do you wish to customize this course to suit your needs?
If so, running the course in-house is probably the best and most cost effective solution.
Medical Device industry
US and Global
Ms. Tammy M. Pelnik,
St. Vrain Group, Inc.
Date, location and venue:
May 16-17, 2018, Copenhagen, Denmark
(Entrance from Kvægtorvsgade)
This course is offered in-house.
Click here for more info and inquiry form.
Day 1: 10.00 - 16.30 (Registration 09.30-10.00)
Day 2: 08.30 - 15.30
14 400 DKK (€ 1 925)
incl. course material (pdf), lunch and refreshments
Note. Due to tax/VAT regulations within the EU (for courses/seminars/conferences), the course fee is invoiced in the local currency and local VAT is added.
Accommodation is NOT included in the course fee.
For groups registered and invoiced together we offer the following quantity discount:
2-3 persons 10%
4 or more 20%
We do not offer or practice any general company discounts without commitments and/or written agreements.
This is primarily to protect the environment. Therefore, we encourage you to bring a laptop / tablet to the course - it is possible to make notes in the PDF file you will have access to.
1-2 weeks prior the course you will receive login details to www.Gate2GMP.com where you can download the course handouts as a PDF.
Note pads and pens will always be provided at the venue.
* If you still want a printed course handouts binder from us, we charge 50 Euro/pcs (of which 10 Euro to TRINE for clean energy projects)
Cancellation of registration:
Registration is binding and when you have received our confirmation the following conditions are known and accepted. If you for any reason is unable to attend, substitution is always possible and preferred.
All cancellations and/or substitutions must have been communicated with and confirmed by us.
Cancellations received less than 30 calendar days before course start are subjected to a service charge of 150 € (Euro)/registered course day as compensation for additional administrative burden and for non refundable part of the conference reservation. Cancellations received less than 7 calendar days prior the course, or failure to cancel or "no-show", will be charged in full.
Cancellation of courses: Courses may be cancelled by the organizer if bookings fail to reach minimum numbers (normally not later than 30 days prior the course start), or due to other reasons beyond our control. In such circumstances charged course fees will be refunded, credited, or granted to attend another course for the same value. NOTE! Key2Compliance AB is NOT responsible or liable to any costs in conjunction with a cancelled course. If you need to book flights way ahead (+35 days prior the course) check with us before finalizing the purchase of flights and/or hotel accommodation for an update on the registration situation.