6th European GMP Conference with pre-conference workshop on Quality Metrics

8-10 June 2015

Heidelberg, Germany

Course No 9306

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Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Richard Bonner
Chairman ECA, UK
Dr Christopher Burgess
Chairman of ECA‘s Working Group on Quality Control
Klaus Eichmüller
GMP Inspectorate, Germany
Dr Afshin Hosseiny
Chairman of ECA‘s GDP Interest Group
Dr Ajaz Hussain
Insight, Advice & Solutions, LLC, USA
Dr Jean-Denis Mallet
NNE Pharmaplan, Franceand ECA Advisory Board Member
Gert Moelgaard
NNE Pharmaplan and Co-Chair of ECA‘s Working Group on Validation
Dr Bernd Renger
Qualified Person,
Immediate Past Chair of the EQPA
Dr Franz Schönfeld
GMP Inspectorate, Germany
Dr Wolfgang Schumacher
F. Hoffmann-La Roche Ltd., Switzerland
Lance Smallshaw
UCB Biopharma sprl, Belgium
Dr Ingolf Stückrath
sanofi-aventis, Germany

Objectives

The EU GMP Conference is only offered every two years. This unique conference will discuss current and planned changes to the GMP regulation. All experts and managers involved in GMP compliance activities will have the opportunity to get a comprehensive GMP update and to talk to the leading experts from industry and authority

Although EU GMP is in the center of attention, a harmonized approach with cGMP from FDA will also be an important aspect of the agenda. For international operating companies both EU GMP and FDA compliance is important and the corporate quality systems need to cover the regulation of both regions.

The agenda will therefore focus on key GMP compliance developments. Attention will be paid on the implementation of these requirements into pharmaceutical quality systems. The ECA Foundation’s objective is to support industry, and therefore current activities as well as guidance documents and SOPs are presented during this conference.

Each Session will have speakers from industry and inspectorates to discuss both expectations and implementation aspects.

We wish you a successful and interesting conference.

Yours sincerely,

Richard M. Bonner
Chairman of the ECA Advisory Board

Target Group

The conference is of particular interest for GMP experts of pharmaceutical companies (e.g. QA, QC, production, distribution, regulatory affairs), of GMP inspectorates and Regulatory Authorities.

Special bonus

Each participant will receive a set of documents developed by the ECA working and interest groups such as:

Latest version of the GMP Matrix (comparison of EU GMP, FDA cGMP and ISO 9001)
OOS SOP developed by the Analytical QC Group
Validation Good Practice Guide developed by the Validation Group
Current chapters of the GDP interpretation developed by the GDP Group in cooperation with PQG

Programme

This session will discuss the latest changes and current initiatives in EU GMP and FDA GMP regulation

Update from recent EU GMP changes
Latest Changes in EU Regulations
Latest Revisions of the EU GMP Guide and its Annexes
New EMA Guidelines with impact to GMPs
Look over the pond - Important GMP developments in the US
Dr Bernd Renger

FDA´s focus on Data Integrity
What are the reasons behind the new inspection focal point?
Data integrity concerns in the US, India and Europe – are there any differences?
The culture of error – how to avoid data integrity problems
Dr Ajaz Hussain

Formalized Risk Assessment for Excipients – a new task for every pharmaceutical company
What does a QP require of an excipient manufacturer?
Do excipients pose a risk to GMP? What could go wrong?
Are there ways to assess and mitigate the risks?
Is a Technical Agreement and Supplier Audit required?
What are the acceptable standards to apply to excipient manufacturers
Richard Bonner

Trending of GMP data is under discussion in the pharmaceutical industry and in authorities. What kind of data should be used for trending? What is a trend in a set of data? What are the consequences of a trend? This will be discussed in presentations covering trends in production and analytical data.

Trending from the regulators point of view
Trending requirements
Authorities’ expectations
Inspection findings
Dr Franz Schönfeld

Case Study: Trending in production
SPC as trending tool
Case Study
Dr Ingolf Stückrath

The new Out of Trend Guidance developed by the ECA Foundation Analytical QC Working Group
Regulatory need for trending analysis
Overview of Analytical QC Working Group
Generation process of this guidance document
Structure and content
Current status and next steps
Dr Chris Burgess

The new EU GDP Guide will not only have a huge impact on Logistic Service providers but will also require from pharmaceutical Industry to establish a system to control and monitor the distribution supply chain of it´s medicinal products.

The enhanced GMP and GDP Inspection activities from the point of view of an EU GMP/GDP Inspector
Authorities requirements
What changed with the EU GDP Guideline revision?
Inspection findings
EU Inspector, to be named

New GDP Guidance Documents and their implementation
Implementation of the EU GDP Guide for medicinal products
The new GDP Guide for APIs
Track and Trace – what will come next?
Dr Afshin Hosseiny

The new PQG/ECA Guidance Documents on GDP implementation
Current status of the documents
Lessons learned from interpretation
Next steps
Dr Afshin Hosseiny

This session will highlight the recent draft Annex 15 to the EU GMP Guide and the relating EMA and FDA Guidance documents.
The new EU GMP Annex 15 from the point of view of an EU GMP inspector
History of validation guidelines in the EU
The EU GMP Annex 15 revision
Links to EMA Process Validation Guideline
What´s really new?
Klaus Eichmüller

Process validation regulations at a crossroad: What should you do tomorrow?
Comparing FDA Process Validation Guidance and EU Annex 15
Equipment qualification: EU and US approaches
Continued Process Verification challenge and opportunities
Continuous manufacturing today and in the future
Gert Moelgaard

Get involved in the ECA Working Groups. Each delegate will be invited to discuss the upcoming developments with the Chair/Co-Chairs of the working groups.

Agenda
You can address topics of interest for you and you can provide feedback on the currently planned activities. It is the aim of the Working Group to provide a platform of discussion with both colleagues from industry and regulatory author

Pre-Conference Workshop on 8 June 2015: How to establish Quality Metrics
This pre-conference session is designed to discuss the implementation of Quality Metrics in the manufacture of medicinal products and APIs. In the centre will be challenges and possible solutions to identify, measure and report meaningful Quality Metrics. For that purpose the ECA Foundation and its interest group, the European Qualified Person Association, have invited stakeholders from industry and authorities.

Speakers from EMA, FDA, MHRA, ECA Foundation, European QP Association and Industry.

Programme

The EMA view on Quality Metrics
What are the potential benefits of Quality Metrics
Risk-based Inspections: The role of Quality Metrics and other risk factors
Drug Shortages and Quality Metrics: Is there a link?

The FDA Quality Metrics Initiative
What triggered the Initiative
Potential Quality Metrics from FDA perspective
How to collect the data
Advantages for industry

Developing, Establishing and Monitoring of Meaningful Quality Metrics in Quality Control
What are the challenges and risks associated with Quality Metrics
Comparison from different data sets
What is Good Quality Control Practice
What are meaningful Quality Metrics for Lab activities

How to use Quality Metrics to control the Supply Chain and the Supplier
How to oversight the Supply Chain?
Is a complex supply chain always a risk?
How to control and measure the supplier in the supply chain
Supply Chain and Supplier Metrics

Inspection based on Compliance Information
How to anticipate supply chain and compliance risks
How to improve compliance-related communication with industry
Implementation a risk-based escalation process regarding inspection results

Quality Metrics and Management Review
Quality Culture as the basis for quality improvements
How to involve the management in Quality Metrics
Set up of a practical review system
Follow up actions on management reviews

Case Study: Quality Metrics
Industry Quality Metrics – typical data sets and reports
How to measure Quality Metrics in daily practice
Lessons learned from implementation
Comparison of Quality Metrics – potential risks and challenges

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