"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 There also has been a Draft Guidance document with further interpretations and that Guide has now been finalised.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.
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Pharmaceuticals and Medical Devices
Recorded 8 March, 2017.
100 min (1:40h)
Price (excl. local VAT):
Recording: 235 Euro
Course handouts (PDF) included.
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