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3rd Clinical Quality Oversight
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Tuesday, May 21 • 8:30am - 12:00pm
AM WORKSHOP: CRITICAL TO QUALITY FACTORS

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Outline a Basic Approach for Identifying the Critical To Quality Factors (CTQs) of the Study and Understand How the CTQs Then Drive Risk-Proportionate Decisions 
  • Review the regulatory changes driving this increased focus on quality
  • Walk through practical ways to understand and evaluate critical to quality factors using case study examples
  • Learn triage questions to easily determine if something is critical to quality
  • Explore ways to evaluate critical to quality factors by looking at most likely failure modes, ways to improve quality, and understand effectiveness
  • Examine the relevance of CTQs for downstream clinical actions, including partner selection and qualification, executing oversight, and auditing  
Speakers
avatar for Leslie Sam

Leslie Sam

President, Leslie Sam and Associates, LLC
Accomplished, results-driven, passionate CLINICAL RESEARCH AND QUALITY PROFESSIONAL with over 20+ years of transferable technical and leadership skills [business acumen, interpersonal skills (verbal and written), Six Sigma Black Belt certification (CSSBB), Quality Improvement Associate... Read More →
avatar for Michael Torok, Ph.D.

Michael Torok, Ph.D.

Vice President, Global Head of Quality Assurance Programs, GENENTECH, a Member of the ROCHE Group
Accelerating therapeutics to patients through innovative operations and quality assurance practices. Improving cross-functional Risk Based Quality Management practices through a robust, organizational Quality Culture with a focus on impactful quality outcomes. Clinical enterprise... Read More →

Tuesday May 21, 2024 8:30am - 12:00pm EDT
  IN-PERSON Experience ONLY, Interactive Workshop