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Technical Guide: Conducting Effective Medical Device Validations

Source: Institute of Validation Technology
Gain a thorough understanding of the basic concepts, techniques, and requirements necessary to meet current FDA expectations and requirements in accordance with the Quality System Regulation with this technical guide
Institute of Validation Technology a thorough understanding of the basic concepts, techniques, and requirements necessary to meet current FDA expectations and requirements in accordance with the Quality System Regulation with this technical guide. Readers will also gain insight into their company's corporate validation policy for conducting timely, efficient, and effective medical device validations. Using case studies and pragmatic examples, readers learn the critical concepts and "principles" of validation.

Topics include but are not limited to the following:

  • Regulatory requirements (law), product safety, process control, and economics
  • Validation: design control and manufacturing
  • Developing the validation master plan and SOPs
  • When to revalidate
  • Creating and executing IQ, OQ, and PQ protocols
  • Using quality tools and statistics
  • Software verification and validation strategies
  • How to deal with change control and out-of-specification conditions
  • Training

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