Design control deficiencies continue to be in the top three FDA Warning Letter findings since 2007. Despite these findings over a long period of time, firms still fail to correct common design control failures. As FDA becomes increasingly frustrated with the level of findings, they have made significant strides to crack down on lapses in design control protocols. If you want to ensure your efforts stand up to any scrutiny, then join us for this comprehensive webinar. By attending, you will learn about robust implementation of a design control process that is both compliant to 21 CFR 820.30 and practical!
Join our online training course where you will learn:
- The importance of design planning – including quality planning
- Design inputs and design outputs – from needs to requirements to specifications
- Design Verification and Validation: learn how to build the right device and build it right
- Integration of risk management into the design and development lifecycle
- Integration of risk management per EN ISO 14971:2012
- Integration of human factors and usability per EN ISO 62366-1:2015