Technical Writing

ELM-505 Technical Writing in a Regulated or Accredited Environment

Technical documents form the enduring record of all the operations within the pharmaceutical industry. Indeed, it is a requirement of current Good Manufacturing Practice that the processes used in the manufacture and testing of pharmaceutical products are described in clearly written, pre-approved, procedures.

Clearly written documentation is the foundation of an effective quality management system, and is of fundamental importance in the pharmaceutical industry.

On successful completion of this course you will understand:

  • The fundamental requirements for technical documents in a regulated or accredited environment
  • Why technical documents are written
  • How technical documents should be written
  • The typical contents of the different categories of technical documents
  • What to look for when reviewing and approving technical documents
  • How to train and assess the competency of those who write technical document
CEU Credits: 0.1
Course Code: ELM-505
Duration: 20 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V2.0
Effective Date: 16/05/2023

Curriculum for this course

Course Introduction
1 min
What You'll Learn
15 secs

Artificial Intelligence

What are Technical Documents?

Accurate
1 min
Useful
30 secs
Concise
30 secs
Complete
45 secs
Clear
1 min
Consistent
30 secs
Correct Spelling, Grammer and Punctuation
1 min
Well Organized
45 secs
Use the Active Voice
15 secs
Use Plain Rather than Complex Language
30 secs
Avoid Unnecessary Words
30 secs
Use Specific Terms
30 secs
When to Use Past Tense
30 secs
When to Use Present Tense
30 secs
Break Up Long Documents
1 min 15 secs
Use an Informal Style
15 secs
Avoid Writing in First Person
30 secs
Define Your Audience
1 min
Write for the Majority
30 secs
Non-Technical Readers
30 secs
Technical Readers
30 secs

Common Mistakes in Technical Writing

What We Covered
15 secs

Test Your Knowledge

Results

This course has been redesigned. The redesign includes new learning objectives to align with updated content, as well as a new exam for those objectives. The visual design has been updated as well. The previous title for this course was Technical Writing in a Regulated or Accredited Environment, Part 1. As part of the redesign, this course's new name is Technical Writing in a Regulated or Accredited Environment.
V2.0

Author

Dr. David Trew

Organic & Analytical Chemist David Trew Consulting Ltd

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