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