Key Take Away:
This webinar 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.
Overview:
Data integrity assessments 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.
Why Should You Attend :
• About the data integrity – the What, Why and How
• How to detect lack of data integrity
• What to do to ensure data integrity
• How to sustain data integrity over time
Areas Covered In This Webinar :
• Data integrity effects on the pharma and biotech industries
• Case Studies illustrating the effects of lack of Data Integrity
• How to detect lack of data integrity and how to plan to ensure data integrity over time
• Data Pedigree
– What is it?
– What Should We Look For?
• Tips and Traps – What to watch out for
• Recommendations and Guiding Principles
Learning Objectives :
• 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 :
• Those Persons who collect, analyse and report data to the FDA
• Pharma and Biotech Professionals including Scientists, Engineers, Quality Control and Assurance, Researchers and Financial Analysts
• Professionals working in R&D, Manufacturing, Quality Assurance, Quality Control, Regularly Affairs and Finance
• Anyone who collects, analyses and presents data to solve problems and make improvements
For more information, please visit : https://www.atozcompliance.com/trainings-webinar/life-sciences/pharmaceuticals/how-to-detect-lack-of-data-integrity/ronald-d-snee/300155
Email: support@atozcompliance.com
Toll Free: +1- 844-414-1400
Tel: +1-516-900-5509
Level:
Intermediate
Speakers Profile:
Ronald D. Snee
Ronald D. Snee, PhD is Founder and President of Snee Associates, a firm dedicated to the successful implementation of process and organizational improvement initiatives. He provides guidance to senior executives in their pursuit of improved business performance using Quality by Design, Lean Six Sigma and other improvement approaches that produce bottom line results.
Prior to his consulting career he spent 24 years at the DuPont Company in a variety of assignments including pharmaceuticals. He has been developing and applying QbD methodologies for more than 30 years. His recent application and research on QbD has produced more than ten articles on use of QbD in Pharma and Biotech. He has also co-authored 2 books on the methods and tools of QbD and speaks regularly at conferences and meetings on the subject. He teaches QbD and related methodologies as an Adjunct Professor at Temple University School of Pharmacy and Rutgers University Pharmaceutical Engineering program.
Ron received his BA from Washington and Jefferson College and MS and PhD degrees from Rutgers University. He is an academician in the International Academy for Quality and Fellow of the American Society of Quality, American Statistical Association, and American Association for the Advancement of Science. He has been awarded ASQ’s Shewhart, Grant and Distinguished Service Medals, and ASA’s Deming Lecture and W. J. Dixon Consulting Awards as well as numerous other awards and honors.
He is a frequent speaker and has published 5 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 Technology Speaker of the Year Award.
