About the Course
Introduction to this course:
This course provides Good Documentation Practices for keeping manual records in compliance with GxP requirements. It gives a clear picture of planning, evaluating, approving, issuing, documenting, preserving, and archiving records. Apply your knowledge through Good Documentation Practices examples.
Who should attend:
This course is ideal for quality assurance personnel, compliance officers, document control specialists, and anyone responsible for creating, managing, or reviewing manual GxP documents.
Learning Outcomes:
By the end of this lesson, you will be able to:
Analyze the principles and purpose of Good Documentation Practices (GDocP) in manual systems.
Apply best practices for designing, generating, reviewing, and approving manual GxP documents to maintain data integrity and traceability.
Implement effective strategies for recording, storing, retrieving, and revising manual GxP documents, enhancing document control and compliance.
What will I gain:
In this course, participants will gain invaluable insights into review processes, storage strategies, and document revision, according to Good Documentation Practices (GDocP) for manual systems.
Prerequisites:
Prerequisites for this course include a basic understanding of quality management systems and familiarity with regulatory requirements in GxP industries. Participants should ideally have experience with paper-based documentation systems.
Additional information:
Course duration: 00:25:49
Course code/version (effective date): L-32/v1.0 (26/04/2023)
Course Categories
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Good documentation practices (GDocP) for paper-based systems
- Lesson 1: Purpose and Principles. Design and generation of paper-based GxP documents.
- Lesson 2: Review, approval, and issuance of paper-based GxP documents.
- Lesson 3: Recording and data capture in paper-based GxP documents.
- Lesson 4: Review, reconciliation, storage, retrieval, revision, and destruction of paper-based GxP documents.
-
Additional resources
- Mind map: Good Documentation Practices
- Reading: 5 must-have templates for managing your QMS
-
Survey
- Course survey
About the Course
Introduction to this course:
This course provides Good Documentation Practices for keeping manual records in compliance with GxP requirements. It gives a clear picture of planning, evaluating, approving, issuing, documenting, preserving, and archiving records. Apply your knowledge through Good Documentation Practices examples.
Who should attend:
This course is ideal for quality assurance personnel, compliance officers, document control specialists, and anyone responsible for creating, managing, or reviewing manual GxP documents.
Learning Outcomes:
By the end of this lesson, you will be able to:
Analyze the principles and purpose of Good Documentation Practices (GDocP) in manual systems.
Apply best practices for designing, generating, reviewing, and approving manual GxP documents to maintain data integrity and traceability.
Implement effective strategies for recording, storing, retrieving, and revising manual GxP documents, enhancing document control and compliance.
What will I gain:
In this course, participants will gain invaluable insights into review processes, storage strategies, and document revision, according to Good Documentation Practices (GDocP) for manual systems.
Prerequisites:
Prerequisites for this course include a basic understanding of quality management systems and familiarity with regulatory requirements in GxP industries. Participants should ideally have experience with paper-based documentation systems.
Additional information:
Course duration: 00:25:49
Course code/version (effective date): L-32/v1.0 (26/04/2023)
-
Good documentation practices (GDocP) for paper-based systems
- Lesson 1: Purpose and Principles. Design and generation of paper-based GxP documents.
- Lesson 2: Review, approval, and issuance of paper-based GxP documents.
- Lesson 3: Recording and data capture in paper-based GxP documents.
- Lesson 4: Review, reconciliation, storage, retrieval, revision, and destruction of paper-based GxP documents.
-
Additional resources
- Mind map: Good Documentation Practices
- Reading: 5 must-have templates for managing your QMS
-
Survey
- Course survey