"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"
Effective Quality Management
How do you make sure that your quality system processes are as effective as possible ?
- For Pharma & Medical Devices
Since 2013 the GMP includes requirements to monitor the effectiveness of the Pharmaceutical Quality System and to perform Management reviews. In this half day course, you will get practical ideas about how to use resources in an effective way and how to integrate the necessary monitoring in the quality processes. The course is interactive and dialogue based with practical examples and cases studies.
Course objective:Learn more about
- What is an effective quality department
- Systematic use of available resources
- Optimisation of quality processes
- Practical use of Quality Metrics and KPIs* in the quality area
- How to increase visibility of the compliance status
- How to conduct Management Review
- How to achieve Top management commitment to Quality
* Key Performance Indicators
Who should attend:
This course is aimed at Managers in Quality Units/functions within Pharma, Biotech and Medical Device firms and other stakeholders that has an interest in effective Quality Management.
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
US and EU
Mr. Hasse Herlevsen
Date, location and venue:
19 June 2018, Copenhagen, Denmark
(Entrance from Kvægtorvsgade)
This course is offered in-house.
Click here for more info and inquiry form.
3.5 hours (½ day)
08.30-12.00 (Registration 08.00-08.30)
3 400 DKK (€ 450) incl. course material (pdf), sandwich 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:
2-3 persons 10%
4 or more 20%
Quantity disconts can not be combined with other discounts or offers.
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.