Course Description
The course has been developed to introduce you to the international requirements for design control and risk management of combination products. There is a particular emphasis on drug – device combinations and drug delivery devices that are regulated as combination products or drug-device combinations in Europe requiring the notified body opinion (NBOp).
We assume no prior knowledge of design control or risk management as many of the attendees will be more familiar with pharmaceutical regulation and cGMP.
Our course is based upon worked examples facilitated by the tutor but also enables participants to discuss their products (without breaching intellectual property restrictions!).
The sessions are a blend of regulatory requirements discussing in particular ISO13485:2016 section 7.1 and 7.3 in particular but also CFR21 Part 4 and CFR21 Part 820.30.
Course Description
The course has been developed to introduce you to the international requirements for design control and risk management of combination products. There is a particular emphasis on drug – device combinations and drug delivery devices that are regulated as combination products or drug-device combinations in Europe requiring the notified body opinion (NBOp).
We assume no prior knowledge of design control or risk management as many of the attendees will be more familiar with pharmaceutical regulation and cGMP.
Our course is based upon worked examples facilitated by the tutor but also enables participants to discuss their products (without breaching intellectual property restrictions!).
The sessions are a blend of regulatory requirements discussing in particular ISO13485:2016 section 7.1 and 7.3 in particular but also CFR21 Part 4 and CFR21 Part 820.30.
Design Control and Risk Management For Combination Products
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