Pharmaceutical Data Integrity : ALCOA and ALCOA+

Incomplete, inconsistent, or untraceable records are among the most cited findings in pharmaceutical inspections. This course addresses the root of that risk, covering the ALCOA and ALCOA+ principles that FDA, WHO, and MHRA expect organizations to apply to every record, system, and process throughout the product lifecycle.

What you’ll learn?

• Principles of data integrity and regulatory expectations (FDA, WHO, MHRA)
• Apply ALCOA and ALCOA+ principles to ensure compliant records
• Identify and prevent common data integrity violations
• Ensure data integrity across paper-based and computerized systems

Who should enroll?

• Quality assurance and quality control professionals
• Manufacturing, production, and laboratory personnel
• Regulatory affairs and compliance specialists
• Professionals responsible for GMP documentation and data management

Upon successful completion, you will receive a validated certificate accredited with CPD/CEU credits, suitable for audit and compliance documentation.

Curriculum:

Introduction

• Why is Data Integrity Important in Pharmaceuticals?
• Who is responsible for ensuring Data Integrity?

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

• Common issues
• Addressing violations

Lesson 5: How to assure data integrity ?

• Quality Culture
• Data Life Cycle Management

Lesson 6: Data Integrity for Paper-Based Systems

Lesson 7: Data Integrity for Computerized Systems

Lesson 8: Role of Quality System in Data Integrity

Conclusion

Glossary

Quiz