This course is appropriate for beginner and experienced person alike. The topics will build on each other and will give you the latest trends in our heavily regulated industry and how to make it easy for yourself while still achieving data integrity.
The attendees will be given take away templates that will enable them to build a complete package to meet Data Integrity Requirements for Computerized Systems.
We have all heard of Computer Systems Validation & Data Integrity, but do you really understand what it is? Do you understand how 21 CFR 11 and Annex 11 fit into this picture? Specifically, can you answer questions on the following:
- 21 CFR Part 11 and Computer Validation: Why so many citations?
- Computer Systems Validation (CSV) and 21 CFR 11 vs Annex 11
- Data Integrity vs Computer Systems Validation
- Overview and Key Requirements of Part 11 & CSV
- How to use a Risk Based Assessment to reduce work while still achieving Compliance?
- How FDA & other Regulatory Authorities Inspect Computerized Systems for Data Integrity?
|08:00 AM — 02:00 PM|
|No. of Days:||1|
GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient.
GlobalCompliancePanel imparts knowledge of best practices across a broad range of user-friendly mediums such as webinars, seminars, conferences and tailored, individualized consulting. These help organizations and professionals implement compliance programs that meet regulatory demands and put business processes in place.GlobalCompliancePanel focuses primarily on providing extensive and quality training in these core areas and anything related to them:
- Risk Management
- Regulatory Compliances
- Corporate Governance
- Quality Management
Through the mediums by which we offer trainings, namely webinars, seminars, conferences and consulting, we bring together the regulators or experts on regulation on the one hand, with the community that needs to learn or be aware of those regulations, on the other.
Professionals who undergo trainings from GlobalCompliancePanel exhibit a vastly improved quality of life in which there is increased productivity and professional growth. In the 10 years for which it has been in the professional trainings industry; GlobalCompliancePanel has developed a rich legacy of courses. It boasts an amazingly large repertoire of 5000 courses, which consist of over 2000 in-person seminars. ...