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Clinical Quality Oversight Forum (CQOF) 2022 has ended
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Tuesday, October 25 • 3:30pm - 4:00pm
Are Your Clinical Oversight Programs Designed and Implemented to Effectively Support an Inspection?

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  • Designing and implementing clinical programs for a successful FDA inspection
  • Building an architecture for a robust program oversight
    • Critical Clinical Research Training
    • Data integrity – impact on clinical oversight programs
    • The importance of a fit-for-purpose QMS
    • CRO oversight
  • Key mechanisms to establish during trials to ensure compliance
  • Vendor lifecycle management
Speakers
avatar for Anthea Dransfield, BSc, MSc, CChem, MRSC

Anthea Dransfield, BSc, MSc, CChem, MRSC

Managing Director, Advarra Consulting
With over 25 years of experience within analytical and manufacturing aspects of cGMP, operational leadership of clinical sites, and quality oversight spanning GxP, Anthea brings a practical approach to Quality. She advocates for structured, phase-appropriate procedures that are defendable... Read More →
avatar for Leslie Paul, MS

Leslie Paul, MS

Director, Advarra Consulting - Quality Center of Excellence
Leslie is a Quality Compliance professional with over 30 years of experience in the FDA-regulated industry. Paul is a former US FDA Investigator experienced in Drug, Medical Device, and Bioresearch Monitoring program inspections. Prior industry roles span the full product lifecycle... Read More →
avatar for Steffen Engel PhD., MBA

Steffen Engel PhD., MBA

Managing Expert, Advarra Consulting
Dr. Steffen Engel is a Managing Expert for Advarra’s Quality Center of Excellence. With 25 years of experience in pharmaceutical quality management systems and process optimization, Steffen also has 7 years’ experience of global consulting for international life sciences organizations... Read More →

Tuesday October 25, 2022 3:30pm - 4:00pm EDT
  Clinical Quality Oversight Forum