"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"
Keep updated in GMP compliance:
Updates on Combo Products
– Final FDA Guidance published!
Completed 8 March 2017. Available as recording.
In June 2013, the FDA published a regulation about Combination Products, 21 CFR 4. There also has been a Draft Guidance document with further interpretations and that Guide has now been finalised.
Combination products are products which combines two or more medical products, it may be a Medical Device and a Drug, a Medical Device and a Biological product or a Medical Device, a Drug and a Biological product for example.
During this Webinar we will briefly look at the background and the actual regulation and then we will give an overview of the content in the Finalised Guide – “Current Good Manufacturing Requirements for Combination Products” from January 2017.
Who should attend:
Anyone in QA, QC, Regulatory, Product Development, Process development or Production that needs to understand about Quality System requirements and CGMP for Combination Products.
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 Devices
Recorded 8 March, 2017.
100 min (1:40h)
Price (excl. local VAT):
Recording: 250 Euro
Course handouts (PDF) included.
For in-house live webinar, contakt us for an offer.
Download and need of software:
The video file is in MP4 / WMV format and is delivered together with the course handouts (PDF) via the WeTransfer service. You have 7 days to download the files.
Most media players can play the file.
If you have problems, we recommend the free VLC media player