Successful completion provides learners with a dated, traceable and downloadable certificate for the course :
Each certificate is CPD/CEU accredited and 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker. They can also be shared on Linkedin.
Data is an invaluable asset for pharmaceutical firms, only if its integrity is well preserved. In pharmaceutical manufacturing, production lines generate a multitude of heterogeneous data sets at different stages of medicine production. The integrity of these data sets is, therefore, critical for ensuring end-to-end traceability. Lack of good data integrity practices impacts the quality and reliability of records, ultimately affecting the quality of pharmaceutical products.
Upon completion of this course you’ll be able to:
In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.
Lesson 1: Overview of data integrity guidance
Lesson 2: Principles of data integrity
Lesson 3: ALCOA Principles for Data Integrity
Lesson 4: Data integrity violations
Lesson 5: How to assure data integrity ?
Lesson 6: Data Integrity for Paper-Based Systems
Lesson 7: Data Integrity for Computerized Systems
Lesson 8: Role of Quality System in Data Integrity