The GMP-Compliance Manager - Online Training Recording
Course No. 19077A
Speakers
Katja Kotter
Vetter Pharma-Fertigung
Ingo Ebeling
Abbott Laboratories
Melanie Kinzner
Sandoz
Dr. Sue Mann
Sue Mann Consultancy
All times mentioned are CET.
Objectives
During this Live Online Training you will learn how the various pharmaceutical quality and documentation systems work and how they interact. Experts from the pharmaceutical industry will show you possibilities to improve your systems and how to run them efficiently and in compliance with (c)GMP.
Background
Pharmaceutical Quality Assurance and GMP Compliance Managers are continuously facing new challenges due to changing regulatory requirements and at the same time increasing needs for efficiency. In this context, QA and GMP-Compliance Managers must be familiar with many GMP-related aspects and systems like:
Non-Conformance Management
Quality Risk Management
Document and Data Governance
Monitoring and Quality Reports
And these are not stand alone systems. They are all linked to each other: A Deviation causes a Failure Investigation which is followed by a CAPA that can lead to a Change and Change Control. All relevant information must be documented in Quality Reviews and Risk Management is the key to almost everything. And everything should be documented and data handled in an integer way. Companies should have all these systems in place. Let’s find out how we can get the most out of them!
Target Group
This Course is designed for all persons in pharmaceutical, biopharmaceutical and API industry’s production and quality units who establish, manage and improve quality and documentation systems.
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.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate:
The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
Programme
Current Regulatory Developments and their Impact on the Quality Management System
New and relevant EU GMP requirements for the Quality Management System
Challenges and Opportunities
Deviation - Investigation – CAPA
GMP requirements and expectations
Deviation management: best industry practice
Performing Failure Investigation
Elements of investigations
CAPA-System and elements
Success factors for an integrated system
Industry approaches for CAPA systems
Quality Metrics and KPIs
From Data Collection to Continuous Improvement
Data Integrity: what the GMP Compliance Manager needs to know about it
What’s it all about (where does the hype come from)
What you need to know about it
What are inspectors looking for?
Risk Analysis - ICH Q9 and FMEA
The Principles of Risk Analysis
A detailed look at FMEA and HACCP
How to apply ICH Q9 “Quality Risk Management”
Process improvement with Risk Analysis
Documentation Systems and their Compliance with the Marketing Authorisation
Testimonials