The GMP-Compliance Manager

The GMP-Compliance Manager

Berlin, Germany

Seminar Nr. 20665

This course is part of the GMP Certification Programme "ECA Certified Quality Assurance Manager". Learn more.

 

Unser Seminarservice

Kosten

ECA-Member*: EUR 1690,--
Non ECA Member*: EUR 1890,--
EU/GMP Inspectorates*: EUR 945,--
APIC Member Discount*: EUR 1790,--

Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.

Zur Anmeldung
* auch unkompliziert per Kreditkarte bezahlbar American Express Visa Mastercard

Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

Ingo Ebeling, Abbott
Melanie Kinzner, Sandoz
Katja Kotter, Vetter Pharma-Fertigung
Veronika Kotzian, Croma Pharma
Sue Mann, Sue Mann Consultancy

Zielsetzung

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.

Hintergrund

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: ƒ
  • Non-Conformance Management ƒ
  • Quality Risk Management ƒ
  • Document and Data Governance ƒ
  • 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!

Zielgruppe

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.

Programm

Current Regulatory Developments and their Impact on the Quality Management System: Challenges and Opportunities
  • New, revised and relevant GMP requirements for the Quality Management System
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
Risk Analysis and Management
  • 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
Case Study: Implementation of an electronic Quality Management System (eQMS)
  • Project overview
  • Cost/benefit analysis
  • Possibilities and limits of an eQMS
  • Interfaces between the various quality Systems
  • Data Integrity: Background and points to consider
  • Example: Change Control Process Flow in the eQMS
Documentation Systems and their Compliance with the Marketing Authorisation
  • Regulatory requirements
  • Document change management: Maintaining compliance
  • Records Retention
  • Archiving
  • 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.

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