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Compliance Seminars®

Medical Device equipment

Essential Corrective Action and Preventive Action Practices

Course description:

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.

In one focused day, you will review the key requirements for a compliant Corrective Action and Preventive Action (CAPA) process, explore international CAPA guidance and common industry practices, and consider alternatives that transform CAPA from paperwork exercise to essential Quality Management System pillar.

Course objectives:

  • Review and discuss ISO 13485:2016’s and FDA’s Corrective and Preventive Action requirements.
  • Discuss the “standard” CAPA process, from incident or adverse data trend through CAPA closure.
  • Compare action planning approaches, and CAPA implementation opportunities.
  • Evaluate options for determining effectiveness of individual CAPAs vs effectiveness of the CAPA process overall, and opportunities for improving CAPA practices.
  • Discuss options for streamlining CAPA to improve efficiency in the QMS.
  • Understand linkages in the Quality Management System between CAPA and other elements.

Course content:

  • Scope & purpose of a CAPA system
  • CAPA process from start to finish
  • When is a CAPA warranted?
  • Corrections vs Corrective Actions – solving the problem the first time
  • Action planning for success
  • Effectiveness at issue and system levels
  • Focus on value-added activities in CAPA
  • Linkages in the QMS: CAPA as a QMS pillar

Note: This course is presented electronically. Each attendee must bring their own laptop to the course venue, Adobe PDF Reader is essential to fully participate in the course.

Who should attend:

Intended for professionals who manage CAPA processes, drive CAPA improvements, and approve CAPA Plans and closure. 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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Comments from our participants:
"Excellent competence in facilitating the discussions during the day!"
"Clarified a lot of things for me. Very useful. Good mix of lessons and exercises."
"Very happy about the course, it gave me a lot to think about and also a few things to try to change in our organization!"


Course facts

Course no:
Medical Device, Drug-Device and Bio-Device combinations and Software-as-a-Medical Device

US, EU, Australia, Brazil, Canada and Japan

Tammy Pelnik
Ms. Tammy M. Pelnik
St. Vrain Group, Inc

Date, location and venue:

18 November 2020, Copenhagen, Denmark
Industriens hus
H.C. Andersens Blvd. 18    

Register by 7 Oct - Save 750 DKK (€ 100)

Specify our booking code D000030870 to get a discount when making a reservation at a Scandic Hotel.
Scandic Hotels nearby:
» Scandic Palace (300m)
» Scandic Webers (650m)
» Scandic Copenhagen (850m)

This course is offered in-house.
Click here for more info and inquiry form.

1 day
08.30-16.30 (Registration 08.00-08.30)

Price (excl. local VAT):
Register by 7 Oct and save 750 DKK (€ 100)
Until 7 Oct: 7 080 DKK (€ 950)
From 8 Oct: 7 830 DKK (€ 1 050)
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 for the same course we offer the following quantity discount:
3 persons or more 15%
We do not offer or practice any general company discounts without commitments and/or written agreements.

Course material (Handouts)  
No printed course material will be provided on our courses*.
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.
3-5 days prior the course you will receive a download link for the course handouts as a PDF.
Note pads and pens will always be provided at the venue.

Cancellation policy - Compliance Seminars®  

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 14 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.