Live Online Training: The GMP-Compliance Manager
Im Auftrag der ECA Academy

Live Online Training: The GMP-Compliance Manager Im Auftrag der ECA Academy

Seminar Nr. 18220

 

Kosten

ECA-Member: EUR 1490,--
Non ECA Member: EUR 1690,--
EU/GMP Inspectorates: EUR 845,--
APIC Member Discount: EUR 1590,--

Alle Preise zzgl. MwSt.

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
Sue Mann, Sue Mann Consultancy

Zielsetzung

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.

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.

Technical Requirements

For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programm

Programme
Wednesday, 04 November 2020
 
Welcome and Introduction

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
Q&A Session
 
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
Q&A Session

Programme
Thursday, 05 November 2020

Welcome and Introduction

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
Q&A Session

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

Q&A Session

Zurück

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