Compliance Consultant, formerly F. Hoffmann La-Roche
Energy Kristina Hansen
MilCor Consulting
Thomas Højsholm Schmidt
CSL Behring
Zielsetzung
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
Hintergrund
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.
Zielgruppe
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
Teilnehmerstimmen - das sagen andere über unsere Seminare:
„"Die Umsetzung mit Memberspot ist wirklich ausgezeichnet gelungen. Es unterstützt die Wissensvermittlung und gewährleistet auch die richtige Durchführung des Kurses.” Christian Wagener, WAGENER & CO. GmbH GMP Basis-Einstiegsschulung (B 1) - Aufzeichnung Online Seminar, April 2024
„Guter, breit gefächerter Überblick mit interessanten Verknüpfungen zur Praxis, welche die Theorie super veranschaulicht.” Marina Kicoranovic, Labor Hartmann GmbH GMP/Basis-Einstiegsschulung (B 14), September 2023
„Die Referenten waren sehr gut! Sie haben sehr klar gesprochen, nur sehr wenige englische Begriffe verwendet (super) und waren sehr praxisbezogen.” Astrid Gießler, Regierungspräsidium Karlsruhe Live Online Seminar - Basiskurs Computervalidierung & Datenintegrität im GxP Umfeld (B 3), Juni 2023
„Sehr guter Bezug zur Schulung für einen GMP-Anfänger. Habe mich sehr gut abgeholt gefühlt.” Dr. Harald Werner, Infraserv GmbH & Co. Höchst KG GMP-Basisschulung (B 1), Juni 2023