Webinars

Vendor Qualification under ICH E6(R3): Risk-Based Approaches for Biotechs


Date & Time: Nov 18, 2026 11:00 AM ET

What do regulations require of clinical trial Sponsors, and how can biotechs qualifying Vendors under time pressure and resource constraints demonstrate a risk-based, compliant process?

This webinar will explore the do’s and don’ts of risk-based Vendor qualification, covering:

  • What ICH E6(R3) requires of Sponsors when selecting and qualifying Vendors

  • Common outsourcing scenarios and practices at biotechs that can lead to inspection findings • Vendor questionnaires vs audits: when each should be applied as a qualification method

  • What a right-sized, compliant process can look like for lean Quality teams

This session is designed for clinical trial professionals in Quality, Clinical Operations, or other functions responsible for oversight of Vendors.


Featuring Speakers:

Blake Jensen

Founder & Principal Consultant at B3 Quality Consulting

Featuring Speakers:

Blake Jensen

Founder & Principal Consultant at B3 Quality Consulting

Featuring Speakers:

Blake Jensen

Founder & Principal Consultant at B3 Quality Consulting

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