This webinar provides some practical and useful answers to the question: “How to Detect Lack of Data Integrity?” Humans, equipment or both can be the source of lack of data integrity. 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 fit together.
Why Should You Attend:
In this webinar, you will learn:- What is data integrity; what does it look like
- Types and sources of data integrity issues as seen in case studies
- 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
- 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.
Areas Covered in the Webinar:
- 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
- Data Pedigree - A New Tool for Assessing the Level of Data Integrity
- 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:
- Department Managers
- Quality Assurance Personnel
- Quality Engineers
- Process and Manufacturing Engineers
- Research and Development Scientists
- Biologists and Microbiologists
- Chemists and Chemical Engineers
- Those who desire to learn how to detect lack of data integrity
- From Pharma and Biotech companies
- Free Materials:
- Copies of slides of presentation
Course Provider
Ron Snee,
