"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"

Compliance Seminars®

Storage of Pharmaceutical products

Validation of software for QMS process

Learn the concepts of QMS software validation, how to assess risks related to QMS software and how to apply IQ, OQ and PQ to QMS software.


Course description:

ISO 13485:2016 introduced requirement #4.1.6 on validation of software used in QMS process. Given the complexity of software design, companies and managers expect hard times when they come to apply classical validation methods to software. Software has its own rules and concepts: failure, bugs, defects and user errors. These concepts and the way to handle them have a significant influence on the validation process.

Knowing how to combine ISO 13485:2016 QMS software validation with activities of software development, installation, configuration and maintenance is the key factor to your success in the software medical device industry.

Course outline:

  • Introduction
  • Validation process
    • Inventory
    • Selection
    • Effort of validation
    • Additional criteria for validation
  • Design qualification
  • IQ, OQ, PQ
  • Special cases: Excel, data backup-restore…

Learning objectives:

  • Learn the concepts of QMS software validation,
  • Learn how to assess risks related to QMS software,
  • Learn how to apply IQ, OQ and PQ to QMS software.

Who should attend:

People working for medical devices or in vitro diagnosis manufacturers:

  • Quality Assurance and Regulatory Affairs Managers
  • Software Project Managers
  • Software Development, Risk Management, and Test Engineers

 

Gate2GMP®

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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.
Watch this short video to learn more about what Gate2GMP® offers »

 

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.

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Course facts

Course no:
5121
Industry:
Medical Device

Level:
Advanced
QS region:
Global (ISO 13485)

Language:
English
Instructor:
Cyrille Michaud
Cyrille Michaud

Date, location and venue:

December 14, 2017, Copenhagen, Denmark
DGI-byen
Tietgensgade 65    
(Entrance from Kvægtorvsgade)

Specify our booking code D000030870 to get a discount when making a reservation at a Scandic Hotel.
Scandic Hotels nearby:
» Scandic Webers (500m)
» Scandic Copenhagen (800m)

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


Time:
1 day
8.30-16.30 (Registration 08.00-08.30)

Price (excl. local VAT):
7 200 DKK (€ 965)
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.

Discounts:
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.

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.
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 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 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.