Organization Name / Organize By
Eventura World
Presented By
Dr. Ronald D. Snee
Sponsored By
Eventura World
Organizing/Related Departments
Quality
Organization Type
Training/Development
WebinarCategory
Both (Technical & Non Technical)
WebinarLevel
All (State/Province/Region, National & International)
Related Industries
Education/Teaching/Training/Development
Research/Science
Biotechnology
Manufacturing
Medical/Healthcare/Hospital
Location
Dufferin, Ontario, Canada
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 :
- 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 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
Others Details
Online Event
Registration Fees
Available
Registration Fees Details
Live- Single
$200.00
Live Corporate
$700.00
Registration Ways
Email
Phone
Website