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Changes to USA Pharmaceutical Legislation and Guidance

Changes to USA legislation and guidance that impact pharmaceutical manufacturing and distribution

Pharmaceutical legislation and regulatory authority guidance is continually changing. These changes, and the interpretation of them, can have significant implications for manufacturers and distributors. Many changes require detailed planning to implement and failure to do so can result in serious compliance problems.

This module aims to provide personnel, in quality, management or technical support roles, for the manufacture or distribution of drug/medicinal products, with the latest changes that will potentially impact their operations. The module covers relevant changes to legislation and guidance emanating from the United States of America.

This module will be available to you for 30 days after your purchase.


This course highlights the proposed and recently implemented changes to guidance issued by US organisations that will impact the manufacture and distribution of drug products, across the product lifecycle, and will provide valuable insights for personnel, in quality, regulatory, management or technical support roles in the pharmaceutical industry. It will help Qualified Persons to fulfil their legal obligation for continuing professional development (CPD) if they are certifying products for the US market.


This course will provide an overview and impact assessment of the following changes emanating from the USA:

  • New/revised legislation and regulations (CFRs)
  • New/revised Guidance for Industry
  • Q&As and concept papers from the FDA
  • FDA inspection observations