Curriculum

Document Control

Document Control in the life sciences industry is a critical function that ensures the accurate, complete, and timely management of all documents throughout their lifecycle. This includes creating, reviewing, approving, distributing, storing, and retiring documents such as standard operating procedures, technical reports, validation protocols, and regulatory submissions.

Learning Paths

Core

The Fundamentals of Good Documentation Practice

Build

21 CFR Part 11 – Electronic Records
21 CFR Part 211 Subpart J – Records and Reports
How to Write Effective Standard Operating Procedures (SOPs)
Technical Writing in a Regulated or Accredited Environment

Refresh

Why Good Documentation Practices are Critical in a GMP Environment
Good Documentation Practices – Date Format
Good Documentation Practices – Time Format
Data Integrity Applies to Everyone in the Organization – ALCOA+ [Video]

Accredited Courses

Fundamentals Series

The Fundamentals of Good Documentation Practice

15 mins

Basic

Accredited Courses

21 CFR Part 11

21 CFR Part 11 – Electronic Records

45 mins

Advanced

Accredited Courses

Good Manufacturing Practices (cGMP) - Advanced

21 CFR Part 211 Subpart J – Records and Reports

45 mins

Intermediate

Accredited Courses

Good Documentation Practices (GDocP)

How to Write Effective Standard Operating Procedures (SOPs)

60 mins

Basic

Accredited Courses

Technical Writing

Technical Writing in a Regulated or Accredited Environment

20 mins

Intermediate

Good Documentation Practices (GDocP)

Why Good Documentation Practices are Critical in a GMP Environment

1 min

Good Documentation Practices (GDocP)

Good Documentation Practices – Date Format

1 min

Good Documentation Practices (GDocP)

Good Documentation Practices – Time Format

1 min

Data Integrity (ALCOA)

Data Integrity Applies to Everyone in the Organization – ALCOA+ [Video]

1 min

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