Course contents

  • Introduction to Good Documentation Practice (PHDP0601)

    Overview of why GDocP is important and what its main principles are.

    It explains the document life cycle and how having standardised ways of working will ensure data integrity, high quality and above all patient safety.

  • Types of Documents (PHDP0301)

    comprehensive guide to understanding the importance of documents within Good Manufacturing Practice (GMP)

    Understand the difference between a record and a document. Know what documents are required in Production and Quality Control and what is a Site Masterfile. Download the checklist to ensure your documents are collecting all the required information.

  • Document Control System (PHDP0401)

    Data Integrity, document lifecycle, retention and archiving.

    This module takes you through the fundamentals of managing documents in a Good Manufacturing Practice (GMP) environment.

  • Creating and Maintaining Documentation (PHDP0101)

    The "dos" and "don'ts" to follow to ensure high quality of documents are created

  • Filling and Recording Information (PHDP0201)

    Defining the rules that must be followed to ascertain the integrity of the information that is being recorded

  • Amending Recorded Information (PHDP0501)

    The fundamentals of the Good Documentation Practice (GDocP) to follow when amending data entry in documents

Learning outcomes

By the end of this module, GMP personnel should understand the best practices of Good Documentation Practices (GDocP) to ensure data integrity, consistency, and high-quality outputs.

  • Learn what Good Documentation Practice is and the importance and benefits of GDocP

  • Understand how GMP documents should be filled in and modified if required

  • Learn the different phases of the document lifecycle

  • Know how GMP documents are approved

Course Features

  • Modules

    Six modules

  • Duration

    5 hours total

  • Language

    English

  • Assessment

    Interactive self assessment

  • Skill level

    Entry level