Data Integrity – Webinar Recording/Transcript

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Data Integrity: Best Practices for Compliance and Maintaining a Culture of Quality

Regulatory guidelines link data integrity with a culture of quality. Does your organization understand how best to manage your data? It must be compliant — maintaining a culture of quality — or you’ll face the consequences of ignoring the rules of documentation.

This presentation will explain high-level data integrity concepts, the definition and importance of data integrity, regulatory expectations for preventing data integrity issues, problem areas for data integrity and strategies for detecting potential data integrity issues in your operations.

Presentation Takeaways:

  • Practical tips for training your staff to look for and detect data integrity issues
  • Recent FDA warning letters citing data integrity
  • Data integrity code of conduct
  • Who is responsible for data integrity
  • Problem areas where data integrity issues can arise
  • Strategies for detecting data integrity issues in QC and laboratory, computer systems and manufacturing
  • Frequency of audits for data integrity in your operations
  • Elements of a quality culture to help prevent data integrity issues
  • How your approach to data integrity issues will affect the outcome

Learn how to control your data, avoid integrity issues and improve your organization.

  • 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

Susan J. Schniepp, a Distinguished Fellow at Regulatory Compliance Associates, Inc., is a pharmaceutical quality assurance thought leader with 40 years of experience. She has held leadership roles in the industry at Allergy Laboratories, Inc.; OsoBio Pharmaceuticals, LLC; Searle; Abbott and Hospira. Ms. Schniepp 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.