Elements of Good Documentation Practices (GDP) and Data Integrity

Elements of Good Documentation Practices (GDP) and Data Integrity


View available dates and register at the host college.

Register at Wake Technical Community College (Course #: SEF-3001KJ1)
Class will be held at Capstone Center
  • Friday, October 16, 2020 - 8:00am to 12:00pm
Instructor: Greg Smith
Tuition: $70.00

An overview of Good Documentation Practices, including the differences between documents and records, the typical ISO 9001 document hierarchy, and each document level. Participants will become familiar with record-keeping requirements including the electronic signature and other regulations in 21 CFR Part 11. Additionally, the appropriateness and qualification of Excel spreadsheets for record-keeping will be reviewed along with how general good practices incorporate FDA compliance requirements outlined in the Guidance to Industry document Data Integrity and Compliance with CGMP.


This course equips any employee who writes, edits, or compiles documents used in manufacturing FDA regulated products, including:

  • Pharmaceutical Production Associates
  • Production Managers
  • Quality Managers
  • Management

Topics Include

This one-day, four-hour course covers the following topics: 

  • GMP Documents
  • GMP Records
  • Document Control
  • Good Documentation Practices
  • 21 CFR Part 211
  • Electronic Records
  • Qualifying Excel Spreadsheets
  • Data Integrity
  • Medicines & Healthcare Products Regulatory Agency

Learning Objectives

Students will:

  • Define and distinguish pharmaceutical documents and records.
  • Detail the regulatory requirements, functional purpose, and typical industrial uses of each document type.
  • Review 21 CFR 11 requirements and resultant impacts on electronic signatures and record keeping.
  • Recognize emerging regulatory expectations for data handling and data integrity assurance.
Elements of Good Documentation Practices (GDP) and Data Integrity

Request this Course


This course may be taught at any location.

Delivery Format

  • Online

Level: Beginner

Lecture HoursLab or Activity HoursTotal

Instructor Pool

Related Information
Lesson 3: In this guided exercise, learners will explore environmental protection policies, look at... more
BioNetwork Capstone Center
Capstone Center in Raleigh is BioNetwork's premiere worker training facility.  At Capstone,... more
Golden LEAF Biomanufacturing Training and Education Center
The Golden LEAF Biomanufacturing Training and Education Center (BTEC) in Raleigh is home to two top... more
Foundations of Clinical Research
Angela Kimel provides a brief overview of the clinical research industry and career opportunities... more