September 21 @ 2:39 pm
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Start2Pharma: Technical writing of WI’s in English
27th May 2019 @ 8:30 am - 5:00 pm
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1. Goal of the training
The aim of this course is to enhance the GMP writing skills of the participants to write clear, standardized, readable and visual work instructions, taking in account human error:
- Clear scope and roles & responsibilities
- A structured practical approach to define the content and structure in a WI (work instruction)
- Attention markers (pictograms) and Pictures (reality on the floor),
- Process flow.
The style and skills required for formal business writing are best developed by practice and experience, but with the right tools and know-how it is a first start.
2. Regulations considered
EU V4 Chapter 4: Documentation, CFR21 Chapter 11 (FDA)
3. Added value
The use of structured work instructions will contribute to:
- Easier reading and more efficient training
- Better tools for trainers
- Less human errors
Creation of a new work instruction of a standardized task selected by the participants + 3 to 4 weeks practice period with a coaching session afterwards via mail.
Learning Objectives
At the end of the course participants will be able to
- Understand the structure of a document system
- Understand the differences between SOP & WI (procedures & work instructions)
- Know the structure of a WI
- Understand the necessity of the right word choice
- Write a structured and logical WI
Scope
- Enhancing GMP writing skills for work instructions
- Comply with the legislation
Methodology
- Theoretical knowledge and awareness
- Exercises through workshops
Program
- Difference between SOP & WI
- Why writing WI?
- Prerequisites to write a WI
- Approach to start developing a WI
- What is the structure of a WI?
- RACI model
- How to write a WI?
- Exercises