The recent influx of concerns over data manipulation and other data integrity questions in India, China and elsewhere has pushed the US Food and Drug Administration (FDA) to put out new draft guidance to help the pharmaceutical industry ensure data is consistent and accurate.
The guidance includes 18 questions and answers on data integrity, alongside well-defined terms on data as they relate to current good manufacturing practice (cGMP) records, as well as recommendations on when workflows on computer systems need to be validated, and how to ensure electronic master production and control records (MPCR) are monitored and can only be used by authorized personnel. “FDA expects that data to be reliable and accurate.
CGMP regulations and guidance allow for flexible and risk-based strategies to prevent and detect data integrity issues. Firms should implement meaningful and effective strategies to manage their data integrity risks based upon their process understanding and knowledge management of technologies and business models,” the guidance says.
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,
"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,”
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.
- 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
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.
- Regulatory VP
- Quality VPs
- IT VPs
- Regulatory Affairs professionals
- Quality Managers
- Quality Engineers
- Small business owners
Industries who can attend
This online course is intended for professionals in the Medical Device Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.