(571) 447-5500

Independent Consultant George Gary Calafactor presents our first EAS On-Demand webinar on Medical Device Quality Audits. Medical Device manufacturers understand the tight FDA regulations and legal obligations surrounding devices. From initial safety and effectiveness study design through Pre-Market Applications (PMAs), Pre-Market Notifications (PMN), registration, Good Manufacturing Practices (GMPs) through reporting of adverse events, every detail must be attended to in a thorough and documented quality system. Quality systems are key indicators of a company’s commitment to producing a safe and effective product as well as a company’s good record keeping practices as records are tested and maintained to provide transparency to FDA inspectors in the case of an audit. This webinar focuses on detailed coverage of Medical Device Quality Auditing including.

  • Learning about the types and purposes of audits
  • How FDA and EU audits differ in scope
  • How quality systems link to other systems within the business practices such as
    • Accounting and Finance
    • Purchasing
    • Customer Service
    • Marketing and Sales
    • Informational Technology
  • FDA’s enforcement requirements of quality systems
  • Quality Assurance
  • Quality Control Testing and Evaluation Against Standards
  • How FDA enforces regulations and gaps found during audits
  • Trends found in FDA enforcement for medical devices in recent years

We invite you to view this free on-demand webinar by clicking here.

Posted in EAS in Action, Medical Devices.