Pharmaceutical Data Integrity : ALCOA and ALCOA+

5/5
8
Data integrity online course

Duration :

2

hour(s)

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

CEU / CPD Accreditation:

Yes

Certification:

Gain a recognized and traceable certificate after completing the course : 

All our certificates are unique, authentic, CPD/CEU accredited, and FDA 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker.

Description:

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:

  • Explain the following concepts related to data integrity and ALCOA, compliant data characteristics, regulatory expectations for data integrity and data control, fundamentals of ALCOA.
  • Assure data integrity in your organization

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.

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

Author:

image
Dr. Ciaran McEnister
Senior Pharmaceutical Executive with 25+ years of experience in Medical Device Development, Translational Research, Pharmaceutical development, Pharmacologic/Toxicologic and Preclinical research and Regulatory compliance of small and large molecule drug candidates. Dr. McEnister has an extended experience as senior quality manager at Merckx, BioDevices and IPSEN.

Reviews:

5/5
8
USD: United States (US) dollar ($)

$60

Buy now
This course includes:
Full lifetime access
Updated content every month
Certificate of completion

GxP-Training Benefits

$60.00

$60.00

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