Process and Design Validation for Devicemakers – Webinar Recording/Transcript
Your medical devices are only as good as your process and design validation.
If your design verification, design validation and process validation are not where they should be, you need this presentation to avoid manufacturing nonconformance, supply chain interruptions and adverse regulatory actions.
Dave Petrich, vice president of quality and regulatory at the Landrich Group, shares everything you must know to improve your design and process validation to ensure the safety, quality and integrity of your medical devices.
He reveals why robust process and design validation studies pay long-term dividends. You’ll come away from this presentation understanding important definitions, recent industry trends and best practices of design and process validation activities.
- Key definitions and differences between design verification, design validation and process validation, including cGMP requirements, installation qualification, operational qualification and performance qualification
- The regulatory basis for design and process validation, including those prescribed under 21 CFR 820.30 (Design Controls), 21 CFR 820.75 (General Principals of Process Validation) and 21 CFR parts 210 & 211
- Trends in 483s and warning letters that impact both design and process validation — including the number and type of nonconformances, and relative percentage of firms that received 483s or warning letters for inadequate design or process validation
- Best practices in design and process validation, including applying design and process validation principles across a product’s entire lifecycle, developing product and manufacturing process master plans early in the development process and updating them regularly, applying risk management principles to validation activities, important considerations for design and process validation studies, and using postproduction and postmarket data to improve design and process validation programs
Your medical devices help no one if you can’t get them to market.
Meet Your Presenter
Dave Petrich, vice president of quality and regulatory at the Landrich Group, is the former quality site head and senior director of design quality assurance at Roche Molecular Systems. He has been a quality and regulatory executive for more than 20 years, leading cross-functional teams to develop, manufacture and commercialize in vitro diagnostics and medical device products. He has expert knowledge of quality management system processes, specializing in design and development, clinical trials/performance evaluations, manufacturing and postmarket support.
Who Will Benefit
- Quality specialists
- Regulatory specialists
- Compliance specialists
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Feb. 8, 2023