Dr Wolfgang Schumacher, formerly F. Hoffmann-La Roche, Switzerland
Lisbeth Bregnhøj, Medicines Inspector, Denmark
In this basic course, you will get an introduction and gain overview in the areas of computer validation (CSV) and data integrity (DI):
- What is computer validation?
- What is GxP data?
- Why is the topic of data integrity currently in the focus of the authorities?
- What are inspectors looking for?
- Why does the topic of "data" affect all sectors?
Through examples and Q&A sessions, you will be comprehensively familiarized with the topic of GxP data.
The integrity of data is one of the basic principles of GMP and GCP / GLP etc. Therefore, it is often referred to as GxP data. In recent years, the issue of data integrity has increasingly become the focus of GxP inspections.
In clinical trials, for example, usually large amount of data is collected and this data is more and more electronically recorded and processed. The check of their data integrity is mandatory. In addition, sponsors contract out an increasing number of tasks in clinical trials to service providers. During inspections of commercial as well as academic trials, an increasing amount of deviations from GCP standards have been identified by the inspectors in view of sub-standard contractual arrangements and related procedures.
Amongst others, the expectation of the GxP inspectors is that companies have systems and procedures in place to ensure data integrity and risk-based audit trail reviews. Compliance with and adherence to these rules is therefore very important. To this end, employees must know and understand these rules.
In practice, the meaning and content of the various GxP requirements and their impact on product quality are often not or only partially aware. In addition, the relevant regulations and guidelines are subject to continuous changes and innovations. This event will therefore illustrate and expand on the practical implementation of these rules by means of examples and Q&A sessions.
Addressed are all employees of the pharmaceutical production and technology, IT, quality control and quality assurance, who work in the GxP environment. Both new and experienced employees, the course facilitates understanding of the GxP measures taken or to be taken and their implementation in the company.
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information
you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Computer Validation (CSV) - Basics
- Structure and elements of CSV
- Guidelines - Annex 11 vs. GAMP 5
- Access concept - User administration
- Data backup
- IT Infrastructure
- Cloud Computing
Data Integrity in the GxP Environment
- ALCOA++ Principles
- Guidelines for data integrity
- Requirements for paper documentation
- Requirements for electronic systems
- Segregation of duties
What is GxP data?
- What is GxP data?
- Risk analysis of critical data
- Data vs. parameters - what is the difference?
- How long must data be retained?
- Requirements for the data archive
Q&A Session 1
DI Risks Based on Examples in Everyday Life
- Examples of risks in the daily handling of GxP data
- Situations from practice and possible solutions
Review of GxP data – Audit Trail Review
- Static and dynamic data
- What data is subject to review?
- ATR - Audit Trail Review
Review by A Second Person - Do we need it?
- Which documents need to be reviewed by the 2nd person?
- Control of blank forms (templates)
DI in GCP
- Data integrity in GCP:
- Critical data
- Risk-based Audit Trail Review
Examples of Observations during Inspections
- What do GxP inspectors look for?
- Preparation for an inspection - correct behavior
- Document unusable, entry forgotten - what to do?
Q&A Session 2