27/05/2019

27/05/2019: “Start2Pharma: Technical writing of WI’s” in English

27/05/2019 8:30 am - 5:00 pm

Start2Pharma: Technical writing of WI’s

Download a PDF synopsis

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
  1. Theoretical knowledge and awareness
  2. Exercises through workshops

Program
  1. Difference between SOP & WI
  2. Why writing WI?
  3. Prerequisites to write a WI
  4. Approach to start developing a WI
  5. What is the structure of a WI?
  6. RACI model
  7. How to write a WI?
  8. Exercises

Ticket Type Price Spaces
Early Bird Ticket €525.00


Practical information

Trainer(s): Natalie Mettepenningen / Els Staes
When: 27/05/2019: 8.30h – 17.00h
Where: Blue Point, Antwerp, Filip Williotstraat 9

This course will be provided in Dutch

Price per day: 750 €/excl. VAT

Discount possible:

  • 30 % discount for early birds  (subscription before 11th January 2018)
  • Until 50% discount through KMO portfolio or training vouchers (DV.O218731)
  • Full reimbursement through Co-valent : https://www.co-valent.be/
  • 50% discount for students and PHD’s

 

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