Data Integrity | Pharma Training Course | PCS Academy

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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

Practical GMP & GDP training for pharma and biotech professionals — taught by senior PCS consultants who advise manufacturers on real GMP issues every week.

  • Language:
    Dutch flag
  • 1 day in total

€ 1197.00 ex. VAT

Registration ends in 69 days.

Reserve your seat

The upcoming start date of this training is guaranteed.

Awaiting approval? Pre-register now — no obligation Open
This training contains:
  • Lunch
  • Digital copy of materials
  • Training certificate

    • What you will be able to do after this course

    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

    Upcoming dates — pick a seat

    Dates Language Price Register
    9/22/26 to 9/22/26 Dutch spoken language (primary) Dutch spoken language (primary) € 1197.00 Register for this date

    About this course

    What this course covers

    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.

    Who this course is for

    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,

    What you take back to work

    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

    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

    Lecturer

    Your trainers are practising PCS consultants. They spend most of their week helping pharma manufacturers respond to real GMP findings, audits and inspections — and bring that experience straight into the classroom.

    Astrid Bulsink avatar

    Astrid Bulsink

    Trainer

    Astrid Bulsink is a senior consultant and project manager with over than 35 years of experience i...

    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 (43)

    4 out of 5 stars

    Based on 43 reviews

    Review data

    5 star reviews

    19%

    4 star reviews

    77%

    3 star reviews

    5%

    2 star reviews

    0%

    1 star reviews

    0%

    4 out of 5 stars

    Strong points (and why):

    De interactie en praktijk voorbeelden waren erg nuttig.

    Jaimee - Teamlead QA Systems

    4 out of 5 stars

    Strong points (and why):

    Goede training met voldoende diepgang voor een groep die reeds wat kennis had en een hele fijne trainer.

    Review:

    Nee, training voldeed aan de verwachtingen.

    Chaimae - Apotheker

    5 out of 5 stars

    Strong points (and why):

    Het open karakter.

    Marc Sam - QA Validatie officer

    5 out of 5 stars

    Strong points (and why):

    Duidelijk, luchtig, goede tempo.

    Bob Chatta - Manager IT

    5 out of 5 stars

    Strong points (and why):

    Informatie over updates van guidelines. Opfrissing.

    Ilona van Charldorp - Consultant

    4 out of 5 stars

    Strong points (and why):

    Duidelijk, educatief.

    Jim Nieuwenhuizen - Medisch Nucleair Analist

    5 out of 5 stars

    Strong points (and why):

    Alles

    Ashna - Assistant Scientist

    5 out of 5 stars

    Strong points (and why):

    Iedereen werd gehoord en alle vragen werden goed behandeld.

    Review:

    Misschien nog een algemeen vragenronde aan het einde doen.

    Justin Vermaat - Chemisch analist

    4 out of 5 stars

    Strong points (and why):

    Het bespreekbaar maken van onze eigen casussen, groepsgrootte was erg fijn. Astrid had veel ruimte voor cases

    Rachelle Granneman - QA-Engineer

    5 out of 5 stars

    Strong points (and why):

    Alles was heel goed georganiseerd en ik heb veel leerzame dingen geleerd.

    Paola kassabian - Microbiologisch analist

    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):

    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

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    Registration ends in 69 days.

    Reserve your seat

    The upcoming start date of this training is guaranteed.

    Awaiting manager approval? Pre-register now. It's free and without obligation. We'll hold your interest and follow up when you're ready to confirm. Pre-register — no obligation
    Difficulty:
    Beginner level Intermediate level
    This training contains:
  • Lunch
  • Digital copy of materials
  • Training certificate
    • Training 5 or more people from the same site?

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