Good Documentation Practice (GDocP)

Rated 5 out of 5
121
gdocp.png

Duration :

2

2 hour(s)

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

CEU / CPD Accreditation:

Yes

Certification:

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.

Description:

Documentation errors are among the most common findings in GMP inspections, and among the most preventable. This course covers the Good Documentation Practices (GDocP) that regulated organizations rely on to keep records accurate, compliant, and audit-ready across manufacturing, testing, and quality operations.

What you’ll learn?

  • Principles of Good Documentation Practices in GMP
  • How to complete, review, and maintain different GMP documents
  • Identify and correct common documentation errors
  • Ensure compliance through proper document control and retention

Who should enroll?

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

Curriculum:

Introduction

Chapter 1 : What are Good Documentation Practices?

Chapter 2 : How and when to apply Good Documentation Practices

Chapter 3: Document types

  • Commitment documents (i.e. new drug applications, new drug master files)
  • Directive documents (i.e. specifications, STPs, SOPs, MPRs)
  • Record documents (i.e. protocols, BPRs, log books, calibration records)

Chapter 4: Good documentation standards

  • Approval
  • Clarity
  • Periodic review and update
  • Formal presentation
  • Records

Chapter 5: How to complete documentation including data collecting forms and batch records

Chapter 6: How to add raw data to forms and lab notebooks

Chapter 7: Typical mistakes

Chapter 8: How to fix data entry mistakes and omissions

Chapter 9: How to date, sign, and mark records

Evaluation

Author:

Ciaran McEnister
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.

Reviews:

Rated 5 out of 5
121

$95

Buy now

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This course includes:
One-year access
Updated content every month
Certificate of completion

GxP-Training Benefits

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$95.00 / year

$95.00 / year

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