This seminar offers medical device manufacturers the opportunity to enhance efficiency and compliance by applying Lean Documentation and Lean Configuration principles. Led by expert Jose Mora, it ...

FDA’s process validation guidance has evolved and the current lifecycle approach has profoundly influenced validation practice. Paul L. Pluta FDA issued the guidance document Process Validation: ...

In January, 2011, FDA released its guidance, Process Validation, General Principles and Practices, describing process validation practices based on quality-by-design principles. In January, 2011, FDA ...

CAI, a global leader in operational readiness and excellence for life sciences and mission critical facilities, today announced a strategic partnership with Valkit.ai, a fast-growing innovator in ...

This seminar will provide an overview and in-depth snapshot of the process for managing V&V activities affecting product, process, equipment and the QMS. Company employees responsible for new product ...

This is something I have heard a lot recently. But it’s not true. The Quality System Regulation 21 CFR Part 820 includes requirements for design controls. The regulation requires design validation to ...

DUBLIN--(BUSINESS WIRE)--The "Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation): 2-Day Workshop "conference has been added to ResearchAndMarkets.com's ...

Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...

Over the years, Electronic Design Automation (EDA) tools have matured considerably. They now aid in design and verification of all aspects of chip manufacturing. One area that has lagged behind is the ...

This file type includes high resolution graphics and schematics when applicable. The SoC design world is full of challenges and unforeseeable hurdles, especially for protocol developers and early ...