Data Integrity

One-day training on implementing and adhering to Data Integrity and the importance of Quality Culture.

Based on 23 participants

GMP & GDP training for pharma & biotech

Language:
1 day in total

€ 922.00 ex. VAT

Registration ends in 315 days.

The upcoming start date of this training is guaranteed.

This training contains:

Lunch

Digital copy of materials

Training certificate

What you will learn

Be able to explain the expectations for Data Integrity

Increasing Data Integrity step by step within one's own organization

Explain and apply the relationship between Quality Culture and Data Integrity

Training Dates

Start date	End date	Dates	Language	Venue	Price	Register
Tuesday, September 30, 2025	Tuesday, September 30, 2025	9/30/25 to 9/30/25	Dutch spoken language (primary)	PCS Training Room	€ 922.00	Register

Description

The Training

One-day training on implementing and adhering to Data Integrity and the importance of Quality Culture.

Data Integrity is a hot topic worldwide right now. Inspectors expect to see sound policies on how to handle data, both with written documents and digital systems. In addition, great responsibility is placed on organizational managers. The culture of quality also determines reliable data. Where errors can be discussed openly and honestly, data will be more reliable and deviations, rejections and complaints will decrease. Our expert shows in one day what the expectations are and how to implement the requirements around Data Integrity within your own organization.

The goal is reliable data and thus consistent, safe and effective medicines for patients.

Target Audience

This training is intended for employees in the pharmaceutical industry, involved in the preparation and management of Deviations and CAPAs, such as: QA Managers, QP, RP, QA Officers, Department Heads, Supervisors and designated staff for this purpose.

If you're a pharmacist or hospital pharmacist interested in earning accreditation points by attending this training,

Results

Employees are aware of Data Integrity expectations from GMP
Reliable data & increased GMP compliance
Decrease in deviations, rejects and complaints
Increased GMP/GDP compliance in the area of Data Integrity
Reliable data and therefore reliable products

What is Data Integrity and why is it so important
Principles of Data Integrity
Different types of data
The impact of quality culture on Data Integrity
What does this does mean for me?
Practical workshop with its own procedure
Personal plan for one's own organization: how to raise the level of Data Integrity
Quiz

Lecturer

Astrid Bulsink

Trainer

Experienced senior consultant and project manager with over 30 years of expertise in quality management and pharmace...

Program

Lecture	Day
Introduction to the course	1
Why is Data Integrity so important?	1
Principles of Data Integrity	1
Data versus Raw Data	1
Impact of Quality Culture on Data Integrity	1
What does this mean for me?	1
Workshop: Data Integrity in Own Process Plan for Data Integrity	1
How to proceed? Data Integrity in your own practice	1
Quiz and closure	1

Practical Information

Difficulty / Level:: Beginner level and Intermediate level
Group discounts:: 2 participants - 5%

3 participants - 10%

4 participants - 15%

4 participants - 20%

6+ participants - 25%
Language (upcoming edition):: Dutch spoken language (primary)

English spoken language (secondary)

Some lectures/lessons may be in the secondary language. The primary language remains the dominant spoken/written language during the training.
Learning form:: Classroom
Times:: Starts at 09:30 and ends at 17:30

Reviews (19)

Based on 19 reviews

5 star reviews: 5%
4 star reviews: 95%
3 star reviews: 0%
2 star reviews: 0%
1 star reviews: 0%

4 out of 5 stars

Strong points (and why):

Dat was eigenlijk de gehele training, een compleet overzicht van DI.

Leonie - QA specialist

2023

4 out of 5 stars

Strong points (and why):

De vakinhoudelijk toevoeging en praktijk voorbeelden van de trainer. Interactie bevorderd de kennis overdracht en maakt het makkelijk toepasbaar.

Jurjen Harkes - Project Engineer

2023

4 out of 5 stars

Strong points (and why):

Elektronische data. Belangrijk om het proces rondom oa elektronische (en uiteraard ook op papier) data goed ingericht te hebben.

Hester Duijn - Kwaliteitsfunctionaris

2023

4 out of 5 stars

Strong points (and why):

Data integriteit in ruwe data, handgeschreven/ afgetekende data. Focus ligt nu bijna alleen maar op computersystemen.

Review:

Nuttig voor QA.

Niels Freriks - Hoofd pharmaceutische ontwikkeling

2023

4 out of 5 stars

Strong points (and why):

Workshop eigen praktijk. Daar kun je zelf mee aan de slag.

Review:

Prima indeling.

Linda Wisselo - Kwaliteitsmedewerker

2023

4 out of 5 stars

Strong points (and why):

Het deel over de cultuur en de back-up van elektronische systemen.

Review:

Cultuur is altijd van essentieel belang en de back-up van systemen nooit zo verder over nagedacht. Ik zou het voor alle functie profielen binnen de farma aanbevelen.

Inge Sloot-Stout - QA specialist

2023

4 out of 5 stars

Strong points (and why):

De discussies die volgden op basis van de onderwerpen.

Review:

Leerzaam om praktijk voorbeelden te horen. Electronic data integrity ontbrak op enkele kritische onderwerpen Electronic data integrity: versioning of data, security levels of users, mandatory comments on changes.

Bennie Klomp - Consultant

2023

4 out of 5 stars

Strong points (and why):

DI checklist. Kan ik toepassen in de praktijk.

Thomas Vromans - QA manager

2022

4 out of 5 stars

Strong points (and why):

In het kader plaatsen en samenhang van de onderwerpen met de bedrijfscultuur. Omdat het in mijn organisatie speelt.

Review:

Goede locatie en lunch.

Louise Heerema - Senior deskundige kwaliteitsrichtlijnen

2022

4 out of 5 stars

Strong points (and why):

Herhaling, even puntjes op de i.

Review:

Ik had iets meer uitleg toegespitst op de Annex 11 en de GAmp5 verwacht.

Annemiek Kok - QA officer

2022

5 out of 5 stars

Strong points (and why):

ALCOA.

Review:

Deze training geeft mij voldoende handvaten om aan de slag te gaan met data integriteit op het gebied van interne documentatie

Leandros Vandijck - Teamleider Serviceteam Apothekersassistenten

2021

4 out of 5 stars

Anonymous - Anonymous

2021

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