Ágnes Kis, form. GMP-Inspector at OGYÉI, Hungary
Christof Langer, OSConsulting, Austria
Thomas Højsholm Schmidt, Leo Pharma, Denmark
Kristina Smith Hansen, MilCor Consulting, Denmark
In this Live Online Training you will have the possibility to learn and intensively discuss how to focus on specific GMP related aspects.
Continuous professional training for auditors and lead auditors is of utmost importance as the authorities expect qualified personal 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 company and the auditee.
Recognising this need for further professional knowledge development, the ECA Academy has set up this Live Online Training as an individual course which is also part of ECA’s Certified GMP Auditor Programme.
This Live Online Training is designed for both new and experienced auditors. It can also be seen as an addition to the ECA Course “The GMP-Auditor”.
For our Live Online Training Courses and Webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
The Root Cause of Poor Personnel Related Discrepancies
- Introduction – humans are rational!
- An explanation for undesirable behaviour
- Utilising behaviour science models to change behaviour
- A brief explanation on Nudging and Behavioural Design
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 Audit Engineering and Technical Operations
- HVAC systems
- Water systems
- Pressured air
- Clean steam
- Special gases
- Room qualification
- Facility layouts
- Flow of material and waste
How to perform Quality Control Laboratory Audits
- Sample receipt and registration
- Sample preparation
- Equipment Calibration and Maintenance
How to audit microbiological laboratories
- Where to look at
- Interpretation of microbiological Data
How to perform an API Site Audit
- Chemical synthesis
- Dedicated vs. multiple purpose facility
- Material dispensing
- Process and cleaning validation
- Cell Banks
How to deal with challenging Personalities in the Audit Room
- Introduction: people are strange!
- Top 10 most frustrating, difficult, or annoying personalities in an audit and how to deal with them