Quality on the Shop Floor - Quality Time

Quality Assurance Operations GMP
Training
  1. Short description
  2. Objectives
  3. Target group
  4. Program
  5. Questions?

On request!

In a GMP environment, frequent interaction takes place between the operations and quality department. During this course we will challenge employees of these departments to get to know each other's responsibilities in an interactive, practical setting.

Duration
2 days
Profession
QA and Operations, including management
Course fee
€ 1495 (excl. VAT)

Short description

The operations and quality department share a common goal; to ensure both GMP compliance as well as the quality of the pharmaceutical product. Consequently, quality assurance is a recurring topic during these interactions.


The human aspects (insight, behavior, performance) will be looked at from the point of view of both QA and operations. We will also address the interactions taking place during various moments of contact. You will learn how to optimize communication by means of practical examples on the shop floor. You are also welcome to share with us any examples of your own work experience.

Objectives

  • Know how to optimize communication between QA and operations
  • Learn more about the cohesion between GMP compliance and the quality of a product 
  • Understand why the human factors insight, behavior and performance are important for quality assurance

Target group

  • QA officers
  • (Senior) operators
  • Operations and QA managers

Program

Day 1

 

Theory

Background of the GMP principles regarding responsibilities and (batch) documentation. Where is the connection with these topics in the daily work routine of QA and operations?
 

Practice: Workshop QA on the shop floor.

What are the topics of communication and areas of interest that play a role in quality assurance?
 

Practice: Workshop in the production area.

The workshop is based on batch documentation. Who has which responsibilities and what sort of interactions take place during and after the production process?

Day 2

 

Theory

Background of the GMP principles regarding the topics training, compliance and deviations. Where is the connection with these topics in the daily work routine of QA and operations?
 

Practice: Workshop in the production area.

Process simulation with deviation. Escalation, handling and reporting.
 

Practice: Workshops in the various classified production areas.

Who has what sort of expertise? What are the critical parameters of a compliance policy? What are critical parameters with regard to product quality?

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Related courses

Interested in signing up a group of people for this course?

Please contact our Business Development team:
info@biotechtrainingfacility.nl
+31 (0)88 2830100

Need help? Have a question or a suggestion maybe?

Drop us a line below or call us on
+31 (0) 88 283 01 00.

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