"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"
Design Controls .... In a Nutshell
– for Medical Device Industry
This two-day course provides you with the knowledge and confidence to interpret the Design Controls requirements in ISO 13485:2016 and the US Food & Drug Administration’s Quality System Regulation.
In two fast-paced, interactive days, you will learn the key requirements for medical device design and development.
- Review and discuss the FDA’s and ISO 13485:2016’s Design Controls requirements.
- Understand the US regulatory approach for medical devices and combination products.
- Identify areas where key EU regulations differ from US design controls expectations for medical devices (and combination products).
- Explore typical auditor questions and intent regarding design controls.
- Identify key resources to support further learning and interpretation.
- Background and scope of design controls regulation in the US and ISO 13485
- Design & development planning
- Design inputs
- Design-era risk management
- Design review
- Design outputs
- Design verification
- Design validation
- Design transfer
- Design changes
- Design History File
- Surviving the audit – providing the right answers
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 with some knowledge of medical device or combination product development, this intermediate-level course is ideally suited to staff needing a broad perspective on design controls, including Research & Development, Engineering, Manufacturing process development, 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.
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.
Medical Device industry
US and EU
Ms. Tammy M. Pelnik,
St. Vrain Group, Inc.
Date, location and venue:
December 12-13, 2017, 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.