Data Integrity and Good Documentation Practice GMP-compliant instructions and records

During this Course you will get to know the principles of Good Documentation Practices in the light of Data Integrity requirements.

You will learn

Experts will show what you need to consider to maintain GMP- compliant documentation systems throughout their life cycle.

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.

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.