This training includes:
One-day training on implementing and adhering to Data Integrity and the importance of Quality Culture.
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
- Dutch spoken language
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.
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.
- 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
- Employees are aware of Data Integrity expectations from GMP
- Reliable data & increased GMP compliance
- Decrease in deviations, rejects and complaints
- Increased GMP/GDP compliance in the area of Data Integrity
- Reliable data and therefore reliable products
(Preliminary content, subject to revision)
- What is Data Integrity and why is everyone so concerned about it?
- Different types of data and expectations from the GMP
- Data Integrity on paper and in computer systems
- Relationship between Data Integrity and Quality Culture
- Practical workshop with its own procedure
- Personal plan for one’s own organization: how to raise the level of Data Integrity
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.
|Learning objectives & course content.|
|Why is Data Integrity so important|
Why is everyone so concerned about it?
What is Data Integrity
|Principles of Data Integrity|
Types of Data Integrity Problems
How bad are Data Integrity issues?
|Data versus Raw Data|
Electronic data recording
|Impact of Quality Culture on Data Integrity|
The Role of Senior Management in Data Integrity
Making mistakes discussable
|What does this mean for me?|
Summary of what has been learned - What does this mean for me?
|Workshop 1A: Data Integrity in Own Process|
Data Integrity Verification (Gap Analysis).
|Workshop 1B: Data Integrity in Own Process Plan Data Integrity|
Improve Data Integrity
Plan for Data Integrity
|Data Integrity in one's own practice|
Translation - theory to practice
|Quiz & Conclusion|
|Start date||End date||Venue||Price||Status|
|03-10-2023||03-10-2023||PCS Training Room||€ 922 ex. VAT||Open for registration|
To start your registration, first select the start date of the training, then fill in the form below.
|Times:||The course starts at 9:30 am and ends at 5:30 pm|