Implementing Data Integrity for Effective Data Governance in Biopharma
Description
Data Integrity is a fundamental principle of Good Manufacturing Practices (GMP). Over the past four years, both the FDA and European inspectors have reported numerous citations related to data integrity. Many US Warning Letters and EU Non-Compliance Reports deal with serious Data Integrity violations. Data Integrity questions have been and will continue to be the focus of many GMP inspections.
Why should you attend
As a consequence international authorities – FDA, EMA, PIC/S, WHO, MHRA – published guidance documents to describe the regulatory expectations of Data Integrity. Although all guidelines are not intended to impose an additional regulatory burden on the regulated companies, a lot of uncertainty predominates the pharmaceutical industry on how to implement these requirements into the daily business.
Objectives
- Get familiar with the current regulatory requirements on data integrity and how regulators refine these requirements
- Get a deeper understanding of what FDA and European inspectors expect from pharmaceutical companies regarding Data Integrity
- Learn how to implement the (new) regulatory requirements on Data Integrity into your Pharmaceutical Quality System
- Learn how to prepare your company for a successful inspection regarding Data Integrity
- Understand how to establish an effective Data Governance System
- Learn how to investigate Data Integrity issues in your company
Who Should Attend
- Managers and staff from Manufacturing, QC/QA, and Analytical Development Laboratories of pharmaceutical companies
- Contract Research Organisation and Contract Manufacturing Organisation manufacturing, laboratory, and QA personnel
- Auditors (internal and external) are responsible for performing self-inspections or external audits and need to understand and assess data integrity
Education Approach
- This training is based on both theory and best practices used in the implementation and management of GDP
- Lecture sessions are illustrated with examples based on case studies
- Practical exercises are based on a case study which includes role-playing and discussions
Speaker
Kossi Molley, PMP, LSSBB, Chemist, Certified Trainer
