Maintaining Data Integrity in GMP Environments
This eLearning module reviews the importance of data integrity in drug manufacturing, common failures in data integrity, and the necessary steps that must be taken to ensure integrity of the data generated at pharmaceutical organizations.
FREE
Course Overview
90+ Hours Training
- Data and its attributes
- What is considered data
- What does ALCOA and ALCOA+ stand for and how does it apply to data integrity principles
- Understanding common terms around data: meta data, audit trails, true copies, electronic records and electronic signatures
- Inputs from USFDA on data integrity related queries and doubts.
- Consequences of data integrity non-compliance
- Common data integrity failures, and the reason for such failures.
Course Curriculum
1 Subject
Maintaining Data Integrity in GMP Environments
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