Ingo Ebeling, Abbott
Melanie Kinzner, Sandoz
Katja Kotter, Vetter Pharma-Fertigung
Sue Mann, Sue Mann Consultancy
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.
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!
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.
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.
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
- Regulatory requirements
- Document change management: Maintaining compliance
- Records retention
- How to keep track of raw data/GMP relevant documentation
- Language: local language vs. English; quality of translation
- Issue/training/effective date vs. new document Version
How to control the Flow of Documents
- Review and approval of Documents
- Batch Record Review process
- GMP process and data flow
- Documentation vs. Data integrity issues
Product Quality Review and Annual Product Review as Quality Enhancement Tools
- Best practices in combining the two reviews
- Statistical background and trending
- Timing of PQRs
- Responsibilities: who is responsible for generation of particular parts of the report, analysis and final conclusion
- Site specific versus product specific PQR
- Challenges and recommendations to overcome challenges
- Examples and case studies
Case Study: How to monitor Suppliers
- Key Quality and Performance Indicators
- Reporting and Monitoring (trend analysis and targets)
- Who is involved – who is responsible?
- Outlook: the FDA Guidance on Quality Metrics
Recording from 03/04 November 2021
Duration of the recording: approx. 9.5 h