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Like so many regulated firms, you may have received findings, observations, a warning letter, or 483 from either an outside audit, registrar, or regulated agency such as the FDA. Don’t panic! There are steps you can take to mitigate the process and become compliant by addressing each one in a planned and organized manner. This webinar will highlight those steps and take you through the process from planning to implementation.

The Audit Failure & FDA Warning Letter presentation will include:

  • Proper planning
  • Initial responses
  • Selecting the right resources
  • Execution and Implementation of Remediation
  • Maintaining Compliance
  • Validation process and procedures
  • Live Q & A session

Vice President of Global Regulatory Compliance, Quality Assurance and Auditing Bob offers over 30 years of experience in quality assurance and regulatory compliance in pharmaceuticals, bio-tech, medical device, engineering and nuclear industries. Among his many accomplishments, Bob gives presentations on a variety of compliance and regulatory subjects worldwide, including most the new ASTM: E2500 model for validation and a variety of life science auditing topics.

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