Data Integrity
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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:
    Dutch flag
  • 1 day in total

€ 922.00 ex. VAT

Registration ends in 281 days.

Register now!

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

    Dates Language Price Register
    9/30/25 to 9/30/25 Dutch spoken language (primary) € 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

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

    Contents

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

    Lecturer

    Astrid Bulsink avatar

    Astrid Bulsink

    Trainer

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

    Program

    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%

    Group discounts are only applicable when multiple participants register for the same course at the same time.

    Language (upcoming edition):
    • nl flag Dutch spoken language (primary)
    • en flag 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

    Tags

    Change Control GMP GDP EudraLex Volume IV Medicines Act Quality Assurance CSV Batch Review Distribution Qualified Person Responsible Person Management Review Data Integrity ALCOA Raw Data

    Reviews (19)

    4 out of 5 stars

    Based on 19 reviews

    Review data

    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

    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

    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

    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

    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

    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

    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

    4 out of 5 stars

    Strong points (and why):

    DI checklist. Kan ik toepassen in de praktijk.

    Thomas Vromans - QA manager

    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

    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

    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

    4 out of 5 stars

    Anonymous - Anonymous

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    Registration ends in 281 days.

    Register now!

    The upcoming start date of this training is guaranteed.

    Difficulty:
    Beginner level Intermediate level
    This training contains:
  • Lunch
  • Digital copy of materials
  • Training certificate
    • Training 5 persons or more?

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