This webinar will give you the tools that you need to ensure that you understand data integrity issues and best practices for ensuring data integrity at your company.
Why should you Attend: The FDA is increasingly focusing on data integrity issues, including data manipulation, when conducting facility inspections. Concerns over data integrity issues have resulted in the agency adding companies to the for-cause inspection list, and the FDA has found questionable data during in a significant number of these for-cause inspections.
The FDA is noticing some electronic data manipulation in parts of its inspection program and is focusing on training its investigators to be more alert to data manipulation, Branding said.
"That harkens back to the time of the generic drug scandal when there were just flat out substitution of products, actual dry-labbing [fabricating scientific evidence] in laboratory notebooks and wholesale substitution of data and information," Branding said.
Agency inspectors are now trained to be looking at inconsistencies or discrepancies that raise questions regarding the validity of records and data, as well as questioning whether pre approval batches are GMP compliant and if unfavorable tests results were recorded.
Areas Covered in the Session:
- What is data integrity
- How it is implemented in your company
- The FDA's position on Data Integrity
- Data Integrity Issues & Warning Letters
- Industry Best Practices for Data Integrity compliance
- Data Integrity in Cloud, Virtualization and Big Data
- Future Trends
Ms Angela Bazigos,
Touchstone Technologies Silicon Valley
Angela Bazigos.CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers. Positions include Chief Compliance Officer at Morf Media. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA. Patent on speeding up software compliance. Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom. National Trainer for Society of Quality Assurance. Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for Life Sciences.