During this Course 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.
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
3 parallel Workshops:
1. Deviations - Failure Investigation - CAPA 2. Quality Metrics and KPIs: from Data Collection to Continuous Improvement 3. Risk Management in Supplier Qualification: How to reduce the effort of qualification without losing control and become non-compliant
You will be able to attend 2 of these workshops. Please choose the ones you like to attend when you register.
This course is part of the GMP Certification Programme "ECA Certified Quality Assurance Manager" Learn more
Testimonials
Seminar Programme as PDF