3-Hour Virtual Seminar on Data Integrity - FDA's Latest Thinking Recorded Webinar | Angela Bazigos | From: Aug 23, 2021 - To: Dec 31, 2021 |
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:-
Why you should 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 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 a 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.
Who Will Benefit:-
Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services.
Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers & Stanford Hospital. Positions include Chief Compliance Officer,Director of QA and MIS Director. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA & DIA Patent on speeding up software compliance.
Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom includes training 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 LifeSciences.
