Good Documentation Practice (GDocP)

4.5/5
21
gdocp

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:

GDocP the mainstay of GMP regulations in a pharmaceutical organization. Appropriate documentation illustrates a detailed picture of all the manufacturing operations done in the past and what is in process and, thus, serves as a basis for planning what has to be done in the future. The quality assurance system of a company regulates the documentation of all processes. It serves as a foundation tool to audit manufacturing and testing operations in a company. Regulatory inspectors rely on company documents and records to conduct inspections of a company’s manufacturing sites.

Therefore, an effective documentation system reflects the competency of the quality assurance system of a company.

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

 

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

 

Glossary

 

Conclusion

 

Evaluation

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
21
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

We might have this course but it's not displayed online. Please type your email and we will get back to you within 24h

No video yet for this course