Overview

The aim of this course is to provide learners with the tools to write better technical documents, focusing on the skills required to produce accurate, precise, succinct documentation within a manufacturing setting.

Course Modules

Module 1: Good Documentation Practice

• What is Good Documentation Practice
• Principles of Documentation for Pharmaceutical and Med tech – EU and FDA Guidelines 
• Documentation Rules 
• Standard Operating Procedures (SOPs) / Work Instructions (WI) 
• Good practice v’s bad practice (checks, rounding, abbreviations etc)

Module 2: Data Integrity

• Assurance of the accuracy and consistency of data over its entire life-cycle 
• Impacts of breach of data integrity 
• Data Integrity and compliance with cGMP Guidance for industry, 21CFR Part 11, Electronic
  records and Electronic signatures 
• Case studies on falsification of data (case studies will vary on audience e.g. Calibration,
  Analytical, Operations). ALCOA plus principles used.

Module 3: Technical Writing

• Purpose and delivery of technical writing
• Planning and presenting technical documentation for a variety of situations
• Writing appropriately for a defined audience
• Designing reports with a logical flow to communicate effectively