Quality Assurance for Clinical Operations: Stress-Reducing Tips for a Successful Regulatory Inspection

Regulatory agencies like the US Food and Drug Administration (FDA), Health Canada, and European Medicines Agency (EMA) are protectors of public health ensuring that medical products are safe and effective for consumers. To certify that their standards have been met, these regulatory agencies conduct several types of inspections both before and after they grant market approval.

While an inspection notice can raise anxiety levels across an organization, knowing what to expect can help you manage the situation and set your team up for a successful inspection. In this webinar, the Quality Assurance experts at SDC and Stiris Research will explain what types of inspections these agencies perform and share stress-reducing tips on how to prepare for a regulatory inspection of your clinical program.

Watch this Webinar to Learn:

• What types of inspections the FDA, Health Canada, and EMA perform
• Typical conduct of a regulatory inspection
• Stress-reducing inspection readiness tips
• Common findings and pitfalls to avoid

Presented by:

• Lisa Cevasco, Director, Quality Assurance at SDC
• Kara Lee McWatters, Director, Quality Assurance at Stiris Research