Data Integrity - Big, Hard and Here to Stay!!
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| Description: | 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. Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to LifeScience Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA. Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She holds a patent in Virtual Validation of Software. She has been on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and is now on the Stanford Who’s Who Registry for contributions to the Lifesciences industry. More recently, Ms Bazigos was quoted in the Wall Street Journal on Using Training to Bring Compliance to the Boardroom. Netzealous - Compliance4All Adam Fleaming Phone: +1-800-447-9407 support@compliance4all.com www.compliance4all.com Event Link : http://www.compliance4all.com/control/w_product/~product_id=500983LIVE/ |
| URL: | http://www.compliance4all.com/control/w_product/~product_id=500983LIVE/ |
| Date: | Thursday, September 8, 2016 |
| Time: | 2:00pm-2:30pm UTC |
| Duration: | 30 minutes |
| Access: | Public |
| Created by: | compliance4all |
| Updated: | Wednesday, August 3, 2016 10:28am UTC |
| : | $150.00 |
| : | 800-447-9407 |
| : | support@compliance4All.com |
| : | Event Manager |
| : | 18004479407 |
| Comments: | None |