GMP Basic

1-day with current GMP-training

Are you already employed in the Life Science industry or would you like to switch to the industry but you lack basic knowledge of GMP? Or are you newly educated and have experienced that missing GMP insight was the reason of why you didn’t get the job? Then this course is just for you.

Purpose

The course provides the participants with a basic insight to the principles of quality understanding and patient safety, based on current Good Manufacturing Practices, legislations and standards within the pharmaceutical industry.

Target Group

The course is targeted academics and technicians, who aim to achieve a basic knowledge within GMP regulated production environments in the pharmaceutical industry, and not yet having an in-depth knowledge or broad experience within the area.

The course is relevant for newly educated as well as experienced, whom consider applying for or have recently been hired for a job in the pharmaceutical industry.

Content

Course content is covering the mandatory training requirements for employees to perform processes in a GMP regulated production environment. The following topics are discussed on the course:

GMP-Background & History

Why do we have GMP today, and why was GMP invented.

Legislation, regulations and standards

How to transform regulations into practice

Change Request, deviations and CAPA

Introduction to Change Request, Deviations and Corrective Actions and Preventive Actions

Qualification, Validation & Risk Management

Introduction to qualification/validation/risk management

Data Integrity

Introduction to data integrity

Inspections & audits

Findings, examples where GMP has been circumvented & warning letters

Good Documentation Practices

RFT – Right First Time, batch records & logbook

Behavior in a GMP Regulated Production Environment

Room classification, airlocks, hygiene & gowning

Good Distribution Practices

Planning, storage, handling & documentation

Teacher

The course is conducted by Consultants from AlfaNordic A/S and the have a broad experience within:
  • Regulatory requirements
  • QA
  • Pharmaceutical production
  • Teaching & training
The course is organized as a combination of lecture room and practical activities, to combine theoretical knowledge with practical understanding, included every day examples from GMP regulated production environments.

Learning objectives

The course provides the participants with a knowledge of:

  • International guidelines and their intended use through the companies QMS.
  • Quality understanding and the underlying operational principles and their significance.
  • Challenges and limitations of working in a highly regulated world.

Related Courses

We also offer these related courses:
  • Afvigelser, CAPA
  • SOP skrivning

Time & Place

Date

Not yet determined, but please let us know if you want to be contacted when the course becomes available.

Course fee

DKr. 3650,00 excl. local VAT

Venue

IDA Conference, Kalvebod Brygge 31-33, 1780 København V

Kursuskalender

November

21.-22. november – Grundlæggende GMP

Ønsker du at få en grundlæggende viden om GMP?

Questions?

Please contact us if you have any questions.

Frank Winther-Hinge
Managing Director & Partner
M: +45 5059 1598
E: fwh@alfanordic.com

AlfaNordic Academy A/S er en strategisk leverandør af kurser og talenter til førende danske og internationale virksomheder indenfor life science-området.

AlfaNordic Academy A/S
Lyskær 8A
DK-2730 Herlev
CVR.nr.: 39335042
Tlf.: 42 36 80 00
Mail: academy@alfanordic.com  

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