Compliance Consultant, formerly F. Hoffmann La-Roche
Energy Kristina Hansen
Novo Nordisk
Thomas Højsholm Schmidt
CSL Behring
Objectives
You will have the possibility to learn and intensively discuss
how to focus on specific GMP related aspects
how to act and react in an audit
Background
Continuous professional training for auditors and lead auditors is of utmost importance as the authorities expect qualified per- sonal performing audits. And GMP audits of suppliers, contract manufacturers and contract laboratories are a fundamental part of a Quality Management System to assure the quality of a drug product. Only knowledgeable and highly qualified auditors with a profound technical knowledge and good communication skills can guarantee audits that are useful for both the auditing com- pany and the auditee.
Recognising this need for further professional knowledge devel- opment, the ECA Academy has set up this practice-oriented course which is also part of ECA’s Certified GMP Auditor Pro- gramme.
Target Group
This course is designed for both new and experienced auditors. It can also be seen as an addition to the ECA Course “The GMP Au- ditor”.
The Root Cause of Poor Personnel Related Discrepancies
Introduction – humans are rational!
An explanation for undesirable behaviour
Utilising behaviour science models to change behaviour
The 3BMethod
How to Audit Quality Systems
What should be included in a Quality System’s audit
Pitfalls when auditing Quality Systems
How to detect Quality System issues
How to Audit Production of Solid Dosage Forms
Risk-based approach
Key points to consider
Exercise with role play
How to Audit Production of Sterile Dosage Forms
Key essentials and points to consider
Case studies
How to Audit Data Governance and Data Integrity
Examples of data governance and data integrity issues
Implications of data integrity issues
Auditors role in data integrity governance
Developing a data integrity audit program – “Hands-on Approach”
How to Perform an API Site Audit
Chemical Synthesis - Dedicated vs. multiple purpose facility - Material dispensing - Cross-Contamination - Process and cleaning Validation - Utilities
Testimonials
Seminar Programme as PDF