WHO Data Integrity Draft Guidance

Описание: In this episode, Stacey is joined by Felicia Ford-Rice, Senior Director Parexel International, the latest guidance from WHO about data integrity.

WHO Guideline: https://www.who.int/medicines/areas/q...

Previous WHO Guideline: https://www.who.int/medicines/publica...

Felicia Ford-Rice leads a team of former FDA Reviewers and Investigators, and utilizes over 25 years of R&D, Regulatory Affairs and Quality Assurance expertise to advise clients on Good Clinical Practice, Good Laboratory Practice, Good Manufacturing Practice and Pharmacovigilance compliance. She provides consulting services on a variety of quality compliance topics including: Strategic GxP Compliance/ Inspection Readiness / Training / Regulatory Risk/ Data Integrity/Failure Investigation/ Change Control / Corrective Action and Preventive Action /Product Complaint Assessments / Regulatory Action Remediation. She holds a Regulatory Affairs Certification, achieved a Master of Management in Business and a certificate in Project Management from Penn State University as well as a BS in Biology from Virginia Tech.

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