Referent:innen

Katja Kotter

Katja Kotter

Vetter Pharma-Fertigung

Ingo Ebeling

Ingo Ebeling

Abbott Laboratories

Melanie Kinzner

Melanie Kinzner

Sandoz

Dr. Sue Mann

Dr. Sue Mann

Sue Mann Consultancy

Teodora-Roxana Petrisor

Teodora-Roxana Petrisor

Bayer

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

The GMP-Compliance Manager

Gesamtes Programm als PDF herunterladen

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
IT-Tools for the Pharmaceutical Quality System
  • Possibilities and limits of an electronic Quality Management System (eQMS)
  • Possible process flows in the eQMS
  • Interfaces between the various electronic quality Systems
  • Data Integrity: Background and points to consider (what the GMP-Compliance Manager needs to know)
  • Outlook: Artificial Intelligence (AI) and GMP: possibilities and limitsQMS
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.

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

Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.

* auch unkompliziert per Kreditkarte bezahlbar
American Express Visa Mastercard

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Zurück

Teilnehmerstimmen - das sagen andere über unsere Seminare:

"Die Umsetzung mit Memberspot ist wirklich ausgezeichnet gelungen.
Es unterstützt die Wissensvermittlung und gewährleistet auch die richtige Durchführung des Kurses.”
Christian Wagener, WAGENER & CO. GmbH
GMP Basis-Einstiegsschulung (B 1) - Aufzeichnung Online Seminar, April 2024

„Danke für das tolle und interessante Seminar! Ich nehme mir fachlich total viel mit und habe viele tolle Menschen kennengelernt.“
Melanie Schifferer, DAIICHI SANKYO EUROPE GmbH
Batch Record Review (QS 23)
September 2024

Guter, breit gefächerter Überblick mit interessanten Verknüpfungen zur Praxis,
welche die Theorie super veranschaulicht.”
Marina Kicoranovic, Labor Hartmann GmbH
GMP/Basis-Einstiegsschulung (B 14), September 2023

Die Referenten waren sehr gut! Sie haben sehr klar gesprochen, nur sehr wenige englische Begriffe
verwendet (super) und waren sehr praxisbezogen.”
Astrid Gießler, Regierungspräsidium Karlsruhe
Live Online Seminar - Basiskurs Computervalidierung & Datenintegrität im GxP Umfeld (B 3), Juni 2023

Sehr guter Bezug zur Schulung für einen GMP-Anfänger. Habe mich sehr gut abgeholt gefühlt.”
Dr. Harald Werner, Infraserv GmbH & Co. Höchst KG
GMP-Basisschulung (B 1), Juni 2023

„Interessante Themen, gut vorgetragen, die eigenen Erfahrungen der Vortragenden helfen, dies noch besser nachzuvollziehen.“ „Gute Gestaltung der Workshops, das Zusammenarbeiten in Gruppen und der Austausch mit anderen hilft sehr.“
Manuela Seibert, Merck, GMP-Leadauditor/in (FA 2), April 2024

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