Overview:
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 preapproval batches are GMP compliant and if unfavorable tests results were recorded.
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.
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
Domestic
International
Data Integrity in Cloud, Virtualization and Big Data
Future Trends
Who Will Benefit:CEO
Regulatory VP
Quality VPs
IT VPs
Regulatory Affairs professionals
Quality Managers
Quality Engineers
Small business owners
GxP
Consultants
Speaker Profile
Angela Bazigos , is the Chief Compliance Officer of Morf Media. She has 40 years of experience in the Lifesciences industry spanning GLP, GCP, GMP, Medical Devices & 21 CFR 11 and has a patent aimed at speeding up Software Compliance.
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com
http://www.compliance4all.com/
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