Goals and Strategies to Meet Audit Requirements

FDA cannot meet the goals of the Initiative alone. The success of the Initiative has been predicated on active participation and input from experts in industry, academia, government, and consumer groups. Emphasize the importance of the Initiative and look forward to many more improvements in regulatory processes for ensuring product quality. The following organizational components of FDA have been actively involved in working toward this modernization over the last four years: ORA, Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation (CDER) and the Center for Veterinary Medicine (CVM), along with various offices within the Office of the Commissioner. All of these organizations continue to promote the goals and objectives of the Initiative and are dedicated to continuing to improve the regulation of pharmaceuticals in the 21st Century.

  • Internal Quality Management Systems
  • External Quality Management Systems
  • Process Analytical Technologies
  • Scientific collaboration activities

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