ONLINE WEBINAR · May 11, 2023, 08:00 AM PDT | 11:00 AM EST | 17:00 CET | 21:30 IST
Identifying Critical Data - The Foundation for Successful RBQM Adoption
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Session Overview: Implementing Risk-based Quality Management (RBQM) in Clinical Trials starts with recognizing critical data. By attending this webinar, attendees will get a better understanding of the process of critical data identification and the importance of that step for a successful RBQM approach implementation.
Overview
Implementing Risk-based Quality Management (RBQM) in Clinical Trials starts with recognizing critical data. Completed in a timely manner, this activity supports Risk Assessment and Quality by Design steps. A well defined critical data identification process complements the process of successful starting up a Clinical Study and lays the foundation for successful RBQM adoption. By attending this webinar, attendees will get a better understanding of the process of critical data identification, and the importance of that step for a successful RBQM approach implementation.
What You will learn
- How to identify critical data
- How to document critical data
- Role of critical data recognition in adoption of RBQM
Who Should Attend
This webinar will be beneficial to beginner through advanced Data Managers with basic understanding of Clinical Data Management and Risk-based Quality Management strategy.
Meet the Speaker
Diana Stelmach
Senior Clinical Data Specialist
Senior Clinical Data Specialist
Medtronic
Diana Stelmach has 13 years of experience working as Clinical Data Manager, ensuring that statistical information and results from clinical trials are recorded and reported accurately and in compliance with internal protocols and state regulations.
Diana is currently the Senior Clinical Data Specialist at Medtronic. She provides Data Management leadership and expertise to clinical teams. She is involved in multiple initiatives focusing on Data Management processes improvements to increase standardization, efficiency and adoption of Risk-based approaches within Clinical Data Management.
She is passionate about Risk-based Quality Management and the transformation of Clinical Data Manager role into the Clinical Data Scientist.
Earn CEUs
SCDM is authorized by IACET to offer 0.2 CEUs for this program. Participants are eligible to receive CEUs upon attendance and successful completion of a web-based assessment within 30 days after the webinar. CEUs are not granted after the 30-day assessment deadline.
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