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FDA Blog

Framework of a Validation Report

By Christina Sanchez Miller, MPH

  12/25/2018

  Category: Good Industry Practices

The U.S. FDA is clear that medical devices and/or significant processes must be validated to ensure the standard of quality is being...

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Initial Pediatric Study Plan (iPSP)

By Biotech Research Group Regulatory Experts

  12/17/2018

  Category: Good Industry Practices

For over 20 years, FDA has promoted the pursuit of increased information and the study of pharmaceutical products in pediatric patients.  This...

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Quality Control vs Quality Assurance

Quality Control vs Quality Assurance

By Christina Sanchez Miller, MPH

  12/03/2018

  Category: Good Industry Practices

Quality is key to any successful business. Quality ensures standards are being met in processes or products. Companies involved in pharmaceuticals, biologics,...

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