GMP-Auditor Practice - Online Training Recording

Costs

*ECA-Member:**	EUR 1790,--
*Regular Fee:**	EUR 1990,--
*EU/GMP Inspectorates:**	EUR 995,--
*APIC Member Discount:**	EUR 1890,--

(All prices excl. VAT). Important notes on sales tax.

Registration

* also payable by credit card

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Speakers

Ágnes Kis, form. GMP-Inspector at OGYÉI, Hungary
Christof Langer, OSConsulting, Austria
Thomas Højsholm Schmidt, Leo Pharma, Denmark
Energy Kristina Hansen, MilCor Consulting, Denmark

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

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