The FDA and other Health Authorities worldwide have focused their attention on data integrity, considering data integrity to be a significant risk to public safety. This is evident in the number of Warning Letter observations and related Import Alerts issued in the last 5-7 years. Data integrity is not a new topic, however, but is a part of the GMPs. Often, companies attempt to address data integrity issues procedurally and by conducting numerous training programs. These tend to be ineffective as data integrity issues are often rooted in a company's culture and may be very difficult to address.
Topics covered in this seminar include the concepts of data integrity Part 11 compliance, risk management, and quality management systems. Through an extensive case study, attendees will work through cultural challenges that contribute to data integrity issues and make change difficult. Many of the examples provided during the seminar will come from the instructor's experience finding data integrity issues during routine supplier audits, and Warning Letter remediation activities that involved data integrity observations. This includes how to conduct a data integrity investigation and targeting the right group for training / discipline.
Learning Objectives:
- Understanding what data integrity is
- Why data integrity is a focus by Health Authorities
- Understand that data integrity is not now - the concepts behind 21CFR Part 11
- Establish the relationship between company culture and data integrity
- Understand how data integrity relates to computerized system implementation and usage
- Applicability of data integrity to legacy systems
- Relationship between print outs and meta data
- How to conduct a data integrity risk assessment
- How to audit for data integrity issues
- How to mitigate data integrity risk
- How to remediate data integrity issues
Areas Covered :
- Regulatory basis for data integrity enforcement
- Cultural basis for data integrity issues and difficulty to effect culture change
- Assessing data integrity risk and mitigation
- How to audit for data integrity issues
- How to remediate
For Registration :
Note: Use coupon code < REFERRAL10 > and get 10% off on registration.