3 Hours Virtual Seminar on Boot Camp: Data Integrity - FDA's Latest Thinking


Duration: 3 Hours  

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In this webinar speaker will explain What is data integrity and How it is implemented in your company, GMP 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.
Angela Bazigos   Product Id : 501869
  Instructor : Angela Bazigos

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Overview:

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 preapproval 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
    • 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 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, http://morflearning.com/angelabazigos/, 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 http://www1.diahome.org/~/media/4FA562336EBD46C58CDC43A8B7773095.ashxPatent on speeding up software compliancehttps://www.google.com/patents/US8266578 . Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroomhttp://blogs.wsj.com/riskandcompliance/2015/07/24/using-training-to-bring-compliance-to-boardrooms/ 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: http://www.stanfordwhoswho.com/Angela.Bazigos.7144112.html#overview.




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