Compliance Consultant, formerly F. Hoffmann La-Roche
Energy Kristina Hansen
Novo Nordisk
Thomas Højsholm Schmidt
CSL Behring
Objectives
In this Live Online Training you will have the possibility to learn and intensively discuss how to focus on specific GMP related aspects.
Background
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.
Target Group
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”.
Technical Details
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
Programme
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
Utilities
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
Reporting
How to audit microbiological laboratories
Where to look at
Interpretation of microbiological Data
Examples
How to perform an API Site Audit
Chemical synthesis
Dedicated vs. multiple purpose facility
Material dispensing
Cross-Contamination
Process and cleaning validation
Utilities
Biotechnology
Cell Banks
Inoculation
Fermentation
Harvest
Purification
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
Recording from 6/7 October 2021 Duration of the recording: approx. 15,5 h
This course is part of the GMP Certification Programme "ECA Certified GMP Auditor" Learn more
Testimonials