Public courses

GBA Key2Compliance solves all your training needs in terms of regulatory requirements, GMP, GXP and quality systems for pharmaceutical & medical device industry.

Below you can browse our upcoming trainings, both on-site in Northern Europe and online. Our network of experts cover a wide range of important and contemporary topics to meet your needs. 

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Test Method Validation (TMV) Made Easy – Part 1 Variable Measurements

How do you know you have quality if you cannot reliably measure what you are doing? Are you afraid of complex statistical concepts and procedures? These two webinars will help you to evaluate your measurement systems, diagnose problems, and fix them. How is it “made easy”?
Feb 24
Online
Statistics, Validation and Qualification

Risk Management according to ISO 14971:2019

Get a good insight and understanding of the key requirements for a risk management system in compliance with EU regulations.
Feb 24
Online
Risk

Test Method Validation (TMV) Made Easy – Part 2 Attribute Measurements

This second webinar will focus on Attribute Measurement Systems – that is, the subjective inspection of items to see if they satisfy requirements. Since humans are the “gauges”, attribute measurement systems can have high variation. How do you evaluate this human judgement and how can you improve their results? And how is it “made easy”?
Feb 25
Online
Statistics, Validation and Qualification

IVDR and requirements on the Quality Management System

- What are the requirements on legal manufacturers, to achieve CE-certification for in-vitro diagnostic devices? - What will the NB need look for when auditing our Quality Management System? - What is the responsibility of the PRRC, in relation to the QMS? This training will give you the answers!
Feb 27
Online
In-vitro Diagnostics, Quality management and QA

Validation of Analytical Procedures Made Easy

What parameters are key to quality? How do we quickly and efficiently identify these parameters and decide on strategies to optimize quality? This webinar is focused on a “Faster, Better, Cheaper” methodology. Targeted to medical device and pharmaceutical professionals involved in meeting Design Control and Process Validation.
Mar 4
Online
Design Control, Statistics, Validation and Qualification

CGMP för kvalitetskontroll (QC) och analysarbete

Fördjupningskurs med specialinriktning mot krav på kemisk och mikrobiologisk kvalitetskontroll under utveckling (klinisk fas) och tillverkning av läkemedel.
Mar 5
Online
QC-lab

Grundkurs i GMP och kvalitetssystem

Introduktion till de regelverk och riktlinjer som gäller vid tillverkning av läkemedel och medicintekniska produkter, dvs GMP och QSReg.
Mar 10
Online
General, GMP, Quality management and QA

Usability for Medical Devices

How do you know if the users think your device is “Easy to use”? Learn how to establish, implement and monitor a usability process.
Mar 12
Online
Usability

GMP Basics for ATMP

This training is an introduction to GMP requirements for both manufacturing of investigational ATMP and ATMP with a marketing authorisation.
Mar 18
Online
ATMP, General, GMP

FMEA Without Tears

This webinar provides a process to conduct FMEA and assess risk in an efficient way where everyone can agree on the results.
Mar 18
Online
Risk

Kvalitetsriskhantering inom läkemedelsindustrin

Varför det är viktigt och värdeskapande att arbeta på ett riskbaserat sätt och hur detta används inom läkemedelsindustrin. Viktiga grundbegrepp och verktyg.
Mar 19
Online
General, Risk

Acceptance Sampling Plans: Inspection by Variables

Get an understanding of the terminology and goals of acceptance sampling plans without delving deep into the statistical theory.
Mar 24
Online
Statistics

CAPA and root cause analysis, tools for an effective CAPA process

Review the key requirements for Corrective Action and Preventive Action (CAPA), explore common industry practices.
Mar 24
Online
CAPA, Quality management and QA

Acceptance Sampling Plans: Inspection by Attributes

Get an understanding of the terminology and goals of acceptance sampling plans without delving deep into the statistical theory. Part 2.
Mar 25
Online
Statistics

Deviation investigation and CAPA in the pharmaceutical industry

This course focuses on root cause analysis and how to execute a successful CAPA management process from initial reporting to root cause analysis for the Pharmaceutical industry.
Mar 26
Stockholm, Sweden
CAPA

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