GMP Masterclass

A practical training in Good Manufacturing Practice (GMP) aspects and quality systems.

Duration
2 day training course
Profession
QA, QC, Operations, Health Care Professionals and everyone working in the pharmaceutical industry
Course fee
€ 1695 (excl. VAT)

Short description

A solid GMP training course is a basic requirement for working in the pharmaceutical industry. Biotech Training Facility therefore proudly presents this GMP training.

Theory and practice go hand in hand during this course, which enables the participants to put all acquired knowledge and skills immediately into practice.

This is a very efficient and practical method to learn the basics of pharmaceutical GMP.

Please note: BIG registered medical specialists (Cluster 2) who follow this course as part of their general education will receive 12 accreditation points.

Objectives

This mid-level GMP training will increase awareness and knowledge of the following topics:

  • Basic principles of GMP for the pharmaceutical industry
  • History of GMP legislation
  • Basic elements of various quality systems in pharmaceutical companies, including Out of Specification (OOS), deviations, change control, GMP documentation, outsourcing of work and process validation
  • GMP requirements for equipment and facilities
  • Basic principles of risk analysis within the pharmaceutical industry
  • Data integrity rules
  • Basics of microbiology and contamination control
  • Performing environmental monitoring
  • Basic principles of GMP within a QC laboratory

Target group

Anyone who wants or needs to know more about GMP, such as QA, QC, and operations staff who perform GMP activities.

Program

Day 1

 

Welcome and introduction

 

Theory

Introduction to GMP history, legislation and basic principles
Quality systems within the pharmaceutical industry, including
Deviations and Out of Specifications
GMP documentation
GMP facility and equipment
Data integrity

 

Practice

Tour of a GMP plant, including a visit to cleanrooms and facilities
Making a buffer while GMP activities are being simulated, including:
● following a batch production record
● filling in a batch production record
● use of raw materials

Day 2

 

Theory

QC activities
Outsourcing of pharmaceutical activities
Change control
Risk assessment within the pharmaceutical industry
Contamination control

 

Practice

Workshop: a risk assessment is performed in order to determine the risks in case of a production/material change
Performing environmental monitoring tests

 

Closure

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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