GMP Masterclass

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

On request!

An intensive 3-day course that covers a variety of topics related to GMP, the pharmaceutical quality management system and to manufacturing requirements, intended for people who want to deepen their knowledge and understanding of why and how to apply GMP.

Duration
3 day training course
Profession
QA, QC, Operations, Health Care Professionals and everyone working in the pharmaceutical industry
Course fee
€ 2595 (excl. VAT)

Short description

This course is a unique combination of theory, workshops and practice. You will use the gained knowledge during the workshops and as a unique feature you can experience being a(an) shopfloor employee performing GMP tasks. Also, you will be the inspector. During a ‘mock’ audit you will inspect our facility and share your findings with the group. 

This training is provided by our trainers who have extensive working experience in pharmaceutical companies. There will be ample of time to answer questions and share experiences with each other. 

Objectives

  • Gain thorough understanding on how to build, maintain and apply a QMS 
  • See beyond the rules and procedures and able to critically assess GMP compliance 
  • Understand what it takes and why to produce a safe and effective medicine 

Target group

Anyone working in a GMP environment who already has a basic understanding of GMP. QA, QC, and operations staff who perform GMP activities. 

Program

Day 1

 

Welcome and introduction
 

Theory & Workshops

GMP refresher
Quality systems
Risk Management
Change Control
GMP documentation
Deviations, CAPA's & OOS
17:00

Close out

Day 2

 

Theory & Workshops

Documentation: Refresher
Training
Audits & Inspections
 

Practice

Preparing a buffer according to a Batch record
Performing an internal audit

17:00

Close out

Day 3

 

Theory & Workshops

Facility & Utilities
Equipment lifecycle
Contamination control
Manufacturing process
Process validation
Tasks of QC department
 

Practice

Tour of a GMP plant, including a visit to cleanrooms and facilities

17:00

Close out & Evaluation

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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.

Thanks