GMP Documentation and Record Retention

4.5/5
18
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Duration :

12

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:

A healthy documentation system is reflective of the quality assurance mechanisms employed in a pharmaceutical manufacturing company. This course introduces you to standards of documentation and records keeping in concert with GMP. A robust documentation and records system provides a framework for looking at the manufacturing process over time at a glance This is very instrumental in making future changes as needed. You will also be introduced to the WHO guidance on good data and record management.

 

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

 

Lesson 1: Why Do We Need Documentation and Record Retention?

 

Lesson 2: What is The Scope of GMP Documentation and Record Retention?

 

Lesson 3: Role of Quality Assurance System in Control and Retention of GMP Documents

 

Lesson 4: Types of GMP Documents

 

  • Instruction Type Documents
  • Record Type Documents

 

 

Lesson 5: The Harmonized Requirements of GMP Documentation and Record Retention

 

  • The WHO Guidance on Good Data and Record Management Practices
  • Annex 5: Good Data and Record Management Practices
  • The USFDA Guidance for Industry: Electronic Records: Electronic                                Signatures: Scope and Application.
  • The EU Guidelines on Good Manufacturing Practice for Medicinal Products                for Human and Veterinary Use: Documentation

 

Glossary

 

Conclusion

 

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:

4.5/5
18
USD: United States (US) dollar ($)

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