Training Staff to Detect Data Integrity Issues - Webinar CD/Transcript

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Training Staff to Detect Data Integrity Issues

Over the past few years, global regulators have increased their focus on data integrity systems.

Who is responsible for data integrity?

Join industry experts Susan J. Schniepp and Linda Biava as they present:

  • High-level data integrity concepts
  • Recent FDA warning letters citing data integrity
  • Problem areas for data integrity
  • Practical tips for training your staff to look for and detect data integrity issues

This 90-minute presentation will cover in detail:

  • The definition and importance of data integrity
  • Data integrity code of conduct
  • Who is responsible for data integrity
  • Problem areas
  • Strategies for detecting data integrity issues
    • QC and laboratory
    • Computer systems
    • Manufacturing
  • Frequency of audits
  • A culture of quality

Order today to gain an understanding of training staff in detecting data integrity issues.

  • Auditors
  • Clinical project specialists
  • Clinical research associates
  • Compliance officers
  • Consultants/service providers
  • Data management and statistics personnel
  • Engineering and design controls teams
  • Executive management
  • General/corporate counsel
  • Investigators                    
  • Managers
  • Manufacturing directors and supervisors
  • Personnel new to the industry

Meet Your Presenters

Susan J. Schniepp, Fellow, Regulatory Compliance Associates, Inc.
As a pharmaceutical quality assurance thought leader with 35 years of  experience, Sue has held leadership roles in the industry at Allergy Laboratories, Inc., OsoBio Pharmaceuticals, LLC., Searle, Abbott and Hospira. She is a member of the PDA Board of Directors; and has served as the PDA / FDA Joint Regulatory Affairs Conference Chair; conference presenter; and Chair of the PDA’s Regulatory Affairs/Quality Advisory Board. 

Linda Biava, RAC, Regulatory Specialist, Regulatory Compliance Associates, Inc.
Linda has over two decades of experience in Regulatory Affairs, Quality remediation, 483/warning letter responses, research and development, and project management. She has provided expertise at Hospira, Organon (formerly Diosynth Inc.), Apotex and the Kansas City Regional Crime Lab.