Data Integrity

4.5 rating based on 23 ratings. 23 students

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. 23 students

GMP & GDP training for pharma & biotech

Language(s):

1 day in total

 922 ex. VAT

Registration is closed.

What you'll 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

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
Course content

LectureDay
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

Course dates

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