Public-registration training

Data Integrity

4.5 rating based on 23 ratings 4.5 rating based on 23 ratings.
One-day training on implementing and adhering to Data Integrity and the importance of Quality Culture.

This training includes:

Upcoming edition starts 03-10-2023

Data Integrity

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

4.5 rating based on 23 ratings 4.5 rating based on 23 ratings.

1 day in total
23 students
Upcoming edition starts 03-10-2023

Data Integrity

What you will learn

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

Explain and apply the relationship between Quality Culture and Data Integrity

Explain the expectations for Data Integrity

Tell us what you want to learn. Get free learning advice by clicking here!

Training language(s)

  • Dutch spoken language

Training 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.

Learning objectives

  • 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

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

Content

(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

Training program

10 lectures in total. The program is subject to change. The final program will be sent to the participants approximately 1 week before the start of the training. No rights can be derived from this program.

Program - eLearning Component
LectureSub-lectures
Program - Day 1
LectureSub-lecturesDay
Learning objectives & course content.

  • Introduction
  • Learning objectives
  • 1
    Why is Data Integrity so important

  • Why is everyone so concerned about it?
  • What is Data Integrity
  • 1
    Principles of Data Integrity

  • Types of Data Integrity Problems
  • How bad are Data Integrity issues?
  • 1
    Data versus Raw Data

  • Data
  • Documentation
  • Electronic data recording
  • 1
    Impact of Quality Culture on Data Integrity

  • Quality Culture
  • The Role of Senior Management in Data Integrity
  • Making mistakes discussable
  • 1
    What does this mean for me?

  • Summary of what has been learned - What does this mean for me?
  • Discussion
  • 1
    Workshop 1A: Data Integrity in Own Process

  • Data Integrity Verification (Gap Analysis).
  • 1
    Workshop 1B: Data Integrity in Own Process Plan Data Integrity

  • Improve Data Integrity
  • Plan for Data Integrity
  • 1
    Data Integrity in one's own practice

  • Translation - theory to practice
  • 1
    Quiz & Conclusion

  • Kahoot!
  • 1

    Training date(s)

    Start dateEnd dateVenuePriceStatus
    03-10-202303-10-2023PCS Training Room 922 ex. VATOpen for registration
    Need training sooner?
    Click here to get personal training options.

    Lecturer(s)

    Registration

    To start your registration, first select the start date of the training, then fill in the form below.

    Participants
    Select the number of participants you are registering.

    - +

    Register now!

    Register for this training by clicking the button.

    General information

    Learning form:Classroom
    Times:The course starts at 9:30 am and ends at 5:30 pm
    Venue(s):
    Start dateVenueRegister

    03-10-2023

    PCS Training Room

    Register

    Preparation:
    Preparation required:Preparation requirements to be announced
    Preparation details:N/A
    Exam:
    Includes exam:No

    Register now!

    Register for this training by clicking the button.