Data Integrity

4.5 rating based on 23 ratings. 23 students

Data Integrity

Eéndaagse training over het implementeren en naleven van Data Integriteit en het belang van 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 ends in 7 days.

Register Now

The upcoming start date of this training is guaranteed.

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

Program - Day 1
LectureDay
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

Course dates

Start dateEnd dateVenuePriceStatus
03-10-202303-10-2023PCS Training Room€ 922 ex. VATRegister

Language

  • Dutch spoken language

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
Data Integrity thumbnail
€ 922 ex. VAT

Registration ends in 7 days.

Register Now

The upcoming start date of this training is guaranteed.

This training includes:

Training certificate

Lunch buffet

10 Lectures

Training 5 people or more?

In-house training may be your best choice! We have more than 100 GxP training courses on demand.

In-house training