eca usa change 2

eca usa change 2

Boston, MA, USA

Course No 46789


Costs

This conference already took place.

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Richard M. Bonner, Chairman ECA Foundation and European QP Association, UK

Dr Susanne Ding, Boehringer Ingelheim, Germany

Dr Rainer Gnibl, EU-GMP Inspectorate, Germany

Dr Bernd Renger, Immediate Past Chair of the European QP Association, Germany

Dr Mark Tucker, Ultragenyx Pharmaceutical, USA, form. US FDA Investigator and Compliance Officer

Objectives

This event is designed by QPs and international Experts as a forum with focus on sharing information and experience and on discussing the critical areas of European GMPs and the QP’s daily work.

Background

The Pharmaceutical Industry is becoming more global due to international collaborations, mergers and acquisitions and more complex supply chains requiring companies to have a greater understanding of pharmaceutical legislation throughout the world. This is becoming increasingly evident by the number of non EU professionals contacting the European Compliance Academy and the Qualified Persons Association asking for more and more detailed information about the European GMPs and the unique role and responsibility of the EU QP.

The ECA Academy and the European QP Association, recognising this need for further professional knowledge development, intend to support the pharmaceutical industry outside Europe in understanding the European approach and legal framework in this respect. Therefore the QP Association has set up the programme at hand on European GMP requirements and the role of the QP.

Representatives from the authorities as well as QPs and well-known experts will talk about the current issues and share their point of view. Various case studies will be presented and discussed to come up with possible solutions.
Make use of this event by exchanging experiences with your colleagues and by establishing informal contact and networking.

I would like to invite you to this unique opportunity, and I look forward to meeting you.

Best regards,
Richard M. Bonner
Chairman of the European Qualified Person Association

Target Group

The Conference has been designed for non-EU QA and QCU personnel, upper management functions and authority representatives who want to be informed about the latest development regarding European GMPs and the duties and responsibilities of Qualified Persons.

Please note

The presentations of this conference will be available for download and your print-out 1 week before the conference. You will also receive a USB stick at the conference’s registration desk.

Note: there will be no print-outs available during the conference.

Programme

Part 1: Understand European GMPs


The EU Pharmaceutical Legislation and the respective Inspection System
  • Legal System
  • Medicinal Products & GMP Legislation
  • EU-Manufacturing Authorization
  • GMP Certificate and Non Compliance
  • General EU-GMP requirements
  • How an EU inspector prepares, conducts and follows-up a GMP-Inspection
  • How a company should prepare an EU GMP-Inspection
EU-GMP/GDP Update - what’s going on at the Moment
  • The EU GMP Revisions and their consequences
  • Revised Chapter 3
  • Revised Chapter 5
  • Revised Annex 15
  • Revised Annex 16
  • Revision Annex 1
  • Revision Annex 17
  • New Annex 21
  • A brief look on the GDP requirements
  • Challenges with diverse FDA expectations
Current and future Co-operation between FDA and the EU
  • EU Mutual Reliance Drug Quality Initiative
  • Global Pharmaceutical Quality for the 21st Century
  • Lifecycle Quality Risk Management
  • FDA’s positions with respect to the differing GMPs and role of the QP
Import of Medicinal Products and APIs into the European Union
  • Differences between originating countries
  • Which types of materials do fall under EU import legislation?
  • Regulatory requirements for import
  • Which documents are needed for import activities of medicinal products and APIs
  • Regulatory procedure to get an import licence to
  • Procedure if a non-EU company imports to different EU Member States
The new EU Lifecycle Approach on Process Validation vs. the US-Approach
  • Difference in US & EU Wording
  • Comparison of validation stages – different, comparable or equal?
  • Comparison US APR & EU PQR and how to synchronize
  • What about Product Quality Reviews of APIs in US & EU?

Part 2: Understand the Role of the QP


The Legal and Professional Duties of the Qualified Person
  • The role of the QP within the pharmaceutical quality System
  • The differences between ICH Q 10 and the US Quality Systems Guidance
  • What the QP is responsible for
  • Batch certification – how is it done?
  • The Role of the QP in Contract Manufacturing and Testing
  • Comparison between the responsibilities of the Head of the US QCU and the EU QP
  • Is there something like a US based QP?
QP Duties and Responsibilities – individual Member States’ Regulations
  • The different Transformation of Directive 2001/ 83 into national laws
  • Article 49 (2) – “minimum conditions of qualification”
  • Article 50 - ‘’established rights and responsibilities”
  • Continual professional development
  • The role of professional bodies in the various member states
  • Selected examples
Annex 16 and the Release of Batches by the QP
  • European and national Guidance and Expectations on investigating Deviations and OOS Results
  • Responsibilities of the QP
  • The QP’s true margin of discretion when releasing batches with deviations
  • Selected examples
The role of the QP in the Supply Chain and Supplier Qualification
  • Proposal to have the QP sign a declaration that the supply chain is secure
  • Supply Chain oversight
  • EU Inspections in the U.S. and the Involvement of the QP

Part 3: Clinical Trial Supplies


Clinical Trial Supplies: IMP Handling in Europe and the Role of the QP
  • Current and future EU-GMP and QP requirements for the release of Investigational Medicinal Products (IMPs)
  • GMP-GCP Interface
  • QP oversight and being a QP in a global environment

USA2017

Go back

GMP Conferences by Topics

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

OK