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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 English flag
  • 1 day in total

€ 922.00 ex. VAT

Registration ends in 75 days.

Register now!

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
    10/1/24 to 10/1/24 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.

    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

    (Preliminary content, subject to revision)
    1. What is Data Integrity and why is everyone so concerned about it?
    2. Different types of data and expectations from the GMP
    3. Data Integrity on paper and in computer systems
    4. ALCOA
    5. Relationship between Data Integrity and Quality Culture
    6. Practical workshop with its own procedure
    7. Personal plan for one's own organization: how to raise the level of Data Integrity

    Program

    Practical Information

    Difficulty / Level:
    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
    training image

    € 922.00 ex. VAT

    Registration ends in 75 days.

    Register now!