During this Course you will get to know the principles of Good Documentation Practices in the light of Data Integrity requirements.
You will learn
How to control blank forms and templates
How to maintain Data Integrity for physical, hybrid and electronic records
How to establish a compliant and pragmatic change control process
How poor documentation practices and falsification can be detected
How to train staff in Good Documentation Practice and Data Integrity
How multilingual documents can be managed and controlled
How to avoid typical documentation failures
Experts will show what you need to consider to maintain GMP- compliant documentation systems throughout their life cycle.
Background
Despite numerous regulatory guidelines poor documentation practice has become more and more a global problem and in most cases it leads to severe violations of Data Integrity principles. The citations regarding Data Integrity issues in FDA warning letters have been increasing dramatically over the past 3 years and also European Regulatory Agencies are concerned about Data Integrity failures in poor documentation not only in companies located in far East but also within Europe.
Both FDA and UK’s MHRA have reacted to this situation by issuing guidances containing clear provisions regarding Data Integrity and documentation e.g. FDA’s CPG objective 3 which covers the laboratory Data Integrity audit or MHRA’s Guidance for Industry on Data Integrity. Also WHO has published a guidance which provides provisions for data governance and contains expectations for records in both paper and electronic forms.
Target Group
This Education Course is designed for managers and staff from Manufacturing, QC/QA and Analytical Development Laboratories of pharmaceutical companies and API manufacturers. Laboratory and QA personnel from Contract Research Organisation and Contract Manufacturing Organisations as well as auditors responsible for performing self-inspections or external audits will also benefit from this course.
Date / Venue /Presentations / Certificate
Date Tuesday, 01 April 2025, 9.00 – 17.30 h (Registration and coffee 8.30 – 9.00 h) Wednesday, 02 April 2025, 8.30 – 17.00 h Thursday, 03 April 2025, 8.30 – 13.45 h All times are mentioned in CEST.
The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site. After the event, you will automatically receive your certificate of participation.
Testimonials
Seminar Programme as PDF