"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"
QA/RA Leader Medical Devices
- Unique training to become certified QA-RA Leader
This 3-day tailor-made training is led by experienced trainers and combines theory with reality-based processes. The aim of the training is to make you well equipped and prepared to lead the QA/RA function in a medical device organization, to give you the latest information in the field of medical device regulations and quality system standards and provide a great opportunity to network with other quality managers.
The training is also designed to serve as preparation if you plan to become certified as “QA/RA Leader Medical Devices” (read more about the certification process at www.sbq.nu.
The person responsible for quality assurance and regulatory compliance in a medical device company need broad and specific knowledge which must be documented. Further, the new EU regulations for medical devices (MDR) and In Vitro Diagnostics (IVDR) requires the manufacturer to appoint a person responsible for regulatory compliance who has specific responsibilities and must show documented evidence of expert knowledge in relevant fields. This training will provide you with valuable tools and knowledge needed for that role.
After completion of this course you will be prepared to….
- Understand how medical device regulations are designed and expected to be observed.
- Ensure products are in accordance with regulatory requirements before being introduced to the market.
- Maintain product safety when the product is put on the market, by working with an implemented management system, including risk management and market surveillance, which meet the requirements of the regulations.
- Have knowledge and understanding of how accident and incident reporting is supposed to work.
Who should attend:
The training is suitable for quality and regulatory professionals who want to strengthen their competency in medical device regulation and quality management systems, and need documented competency as “person responsible for regulatory compliance”.
It is also designed to serve as preparation for a personal certification as “QA/RA Leader Medical Devices” (read more about the certification at www.sbq.nu.)
Take this training if you:
- are experienced in the role as a Quality/Regulatory Manager or Quality Leader and wants to develop yourself further and get your skills documented.
- need professional development that will benefit both you as individual and the organization.
- Medical Device Regulations - Regulatory framework in EU and US, and (briefly) in other markets. The definition of a medical device. Requirements for market access in EU and US. General quality system requirements.
- Role and responsibility of the person responsible for regulatory requirements as defined in MDR/IVDR .
- Quality Management Systems - ISO 13485:2016, interpretation of the standard, how to assess and monitor the efficiency of the quality system. Release/control of a product under a QMS.
- Product Development - The product development process – how to define the start and end of the development phase; demonstrate compliance to the regulations and decide on market release. The role of QA and RA in the development process.
- Product maintenance – how to manage the content of the Design and Development files (DHF) in relation to changes to the product, in the production process and feedback gained from the market (PMS).
- Marketing control - Post-market surveillance (PMS), Medical Device Reporting / Vigilance, Postmarket Clinical Follow-up, Control of Marketing materials.
Prerequisites (previous knowledge):
Two years’ experience or more of working with quality and regulatory questions in medical device or pharmaceutical industry. Training/knowledge about QSR and ISO13485 corresponding to the content of our course in ISO13485 and QSR (#5314).
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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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.
Intermediate / Expert
US and other areas will also be addressed.
Date, location and venue:
30 January - 1 february 2018, Copenhagen
(Entrance from Kvægtorvsgade)
This course is also offered in-house.
Click here for more info and inquiry form.
Day 1: 10.00-appr. 19.30* (Registration 9.30-10.00)
Day 2: 8.00-17.00
Day 3: 8.00-16.00
*Note. Evening session as group workshop. The time can vary.
Supper is not included.
Price (excl. local VAT):
17 900 DKK (€ 2 395) incl. course material (pdf), lunches and refreshments.
Note. Due to tax/VAT regulations within the EU, the course fee is invoiced in the local currency.
Accommodation is NOT included in the course fee.
The individual certification test is carried out separately by SBQ Certification AB.
» More information and application at www.sbq.nu
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.