"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 There also has been a Draft Guidance document with further interpretations and that Guide has now been finalised.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 »
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Pharmaceuticals and Medical Devices
This webinar was conducted 8 March, 2017.
10.00-11.30 (90 min)
Price (excl. local VAT):
190 Euro for the first participant.
90 Euro for the following participants on the same registration and invoice.
Course handouts (PDF) and certificate of attendance is included.
For larger groups, please contakt us for an offer.
Recording: 190 Euro
You need access to a computer, tablet or mobile phone with internet connection (preferably min 700kB/s) and audio capabilities (speakers or headphones).
We are using the application "Gotomeeting" which is very simple to use.
See more about how it works and system requirements here »
Instructions will be attached to your order confirmation.
Cancellation policy for webinars:
Cancellations received less than 24 hours before the webinar will be charged 50% of the course fee.
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.
In case of failure to cancel before the course, the course fee will be charged in full.
Cancellation of webinars:
Courses may be cancelled by the organizer if bookings fail to reach minimum numbers. In such circumstances charged course fees will be refunded, credited, or granted to attend another course for the same value.