Data Integrity for Effective Data Governance in Biopharma

Description

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