2016 - Webinar on How to Detect Lack of Data Integrity

Description :
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 :
What is 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 Will Benefit:
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