How to Detect Lack of Data Integrity

Data are central to the development, manufacture and marketing of pharmaceuticals of all types. The renewed interest in data integrity raises questions regarding what is data integrity and how to assess it. Lack of data integrity comes in two forms: purposeful manipulation of the data to deceive and the inadvertent problems that occur in the production and analysis of data. Humans, equipment or both can be the source of the problem.

This session discusses both types of data integrity sources and introduces the assessment of “data pedigree” as a concept that puts focus on the types of data integrity issues and analytical and statistical methods for detecting data problems. Pharma and biotech case studies are used throughout the presentation to illustrate how the various approaches together.

Areas Covered in the Session :

• Understanding data integrity; what does it look like
• Case studies illustrating types and sources of data integrity issues
• Procedures for assessing data pedigree, integrity and quality
• Computer, analytical and statistical methods for evaluating data integrity and quality
• Limitations of observational data
• Guiding principles, tips and traps for the effective data integrity assessment

Who Should Attend:

• Senior management
• Quality Assurance Team Members
• Quality Control Team Members
• Compliance Auditors
• Process Development Team Members
• Supply Chain and Logistics Managers
• Regulatory Affairs Team Members
• Engineering Staff
• IT Management and Staff working in regulated areas

Course Director: DR. RONALD D. SNEE

Ronald D. Snee, PhD, is Founder and President of Snee Associates, LLC. He provides guidance to senior executives in their pursuit of improved business performance using Lean Six Sigma, Quality by Design (QbD), and other data-based improvement approaches that produce bottom line results. He has played a leadership role in 32 major improvement initiatives for firms such as Novartis, Human Genome Sciences, and Kraft Foods. Ron also serves as Adjunct Professor in the Temple University School of Pharmacy and Rutgers University Pharmaceutical Engineering Program. Prior to entering the consulting field he worked at DuPont for 24 years in a variety of assignments including pharmaceuticals. He received his BA from Washington and Jefferson College and MS and PhD degrees from Rutgers University. Ron in an Honorary Member of the American Society for Quality and has been awarded the ASQ’s Shewhart, Grant and Distinguished Service Medals. Other awards and honors include the American Statistical Association’s Deming Lecture, W. J. Dixon Statistical Consulting Excellence and Gerald J. Hahn Quality and Productivity Achievement Awards. He is a frequent speaker and has published six books and more than 300 papers in the fields of performance improvement, quality, management, and statistics. He is a past recipient of the Institute of Validation’s Speaker of the Year Award.