"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"
- Important news in QA/QM, GMP and Quality Systems
This course gives you the opportunity to share updates and news related to the requirements of GMP and quality systems (ISO 13485 and 21CFR820) within both the EU and US.
The course includes general briefings in both areas and more specific updates related to pharmaceutical GMP demands and to quality system demands for medical devices, respectively.
Course is aimed at:
- Individuals working with audit / self-inspection and audit of suppliers
- Supervisors / managers in production, quality, regulatory or product development
- Process engineers, quality engineers, quality assurance and process developers
During the course, topics that are trending, have news value, or where additional focus is based on both the needs of industry and public authorities priorities, are being presented and discussed.
General, common blocks are alternated with industry-specific blocks (drugs and medical devices), and these specific blocks are in parallel sessions. During the training, group exercises with a focus on sharing knowledge and experience will also be conducted.
After the course you should have gained new knowledge about the latest trends and updates within GMP and quality system areas.
The course will fulfil the expectations of continuous training and professional development for auditors and other key personnel.
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 »
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.
Pharmaceuticals and Medical Device
EU and US
This course is offered in-house.
Click here for more info and inquiry form.
9.00-17.00 (Registration 08.30-09.00)
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.
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.
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.