. Qualified Person Forum 2017 .

Qualified Person Forum 2017

30 November - 1 December 2017

Objective

This Conference is designed by QPs for QPs as an international Expert Forum with focus on sharing information and experience and on discussing the critical areas of the QP’s daily work.

Target Group

The Forum is designed for all Qualified Persons and aspiring Qualified Persons. It also addresses upper management functions and authority representatives who want to be informed about the latest development regarding the duties and responsibilities of Qualified Persons.

Forum Moderator

Aidan Madden

Pre-Conference-Sessions: Please also see the Pre-Conference Sessions on 29 November 2017.

Programme

KEY NOTE: The X-Factor – Sue Mann
  • Human behaviours and errors & what the QP needs to know about these

Current and future Activities of the FDA - Matthew Scherer

  • The role of the EU office
  • The MRA with the EU and other international collaborations
  • Current and future strategies
What the QP needs to know about Continuous Manufacturing and Real Time Release – Eric J.M. Meier
  •  Batch definition in continuous manufacturing
  • Important GMP and Quality aspects to consider
  • Control Strategy using PAT and automation
  • State-of-control operation
  • Batch Release
Falsifications: Handling, Decision Making and Communication – Rolf Ratke
  • A case study on the amount of activities and involvement of the QP
International Developments and their possible Impact on GMP and Manufacturers – David Cockburn
  • Brexit
  • MRA with FDA and other MRAs
  • The role of WHO in regulating GMP
  • What is on the horizon in the GMP area
What the QP needs to know about the current Cleaning Validation Requirements – Walid El Azab
  • What is new?
  • Minimising the risk of cross contamination
  • Change control and information flow
  • Involvement of the QP
The Involvement of the QP in Auditing – Sean Brennan
  • What is necessary
  • How to instruct a 3rd party (or own company) Auditor
  • How to interpret 3rd party audit reports
  • What to do with a negative audit outcome (QP Declaration and supplier approval)
Update: International Harmonisation and Working – Mark Birse

Parallel Sessions

Working on Case Studies

You will be able to attend three of these parallel sessions. Please choose the ones you'd like to attend when you register for the Forum. 

1) GMP-Update: new Regulations and Guidance – what is relevant for the QP? – Bernd Renger and Rainer Gnibl
  • Discussion, questions, answers

 2) Quality Oversight and Enforcement as Part of the Batch Certification Process – Birgit Schultz and Cristina Klitgaard

  • Novo Nordisk Case Study
  • Group work: What is needed for a QP with regard to Quality Oversight and enforcement in order to release a product?


3) QP Scenarios – How serious could they be? – Sue Mann and Gillian Renouf

  • Make decisions based on real-life situations


 4) IMP QPs implementing Annex 16: Continuing to shed Light on grey Zones and sharing Experiences – IMP Working Group

  • How to handle one off deviations
  • How to rely on the Pharmaceutical Quality System (PQS) in Development and IMP Manufacturing
  • To delegate or not to delegate?


5) Serialisation: What is important for the QP – Afshin Hosseiny, Ulrich Kissel and Andreas Kraßnigg

  • Delegated Act for the Safety Features: the impact for the QP
  • Challenges and possible Solutions


6) Quality Risk Management for the QP – Richard M. Bonner and Aidan Madden

The term “quality risk management” is used throughout the revised Annex 16. But how could the QP use this tool? In this session you will get some practical advice!

Q&A Session

During the 2 days of the Forum, delegates can post their questions. The answers will be given by the expert speakers in a dedicated session and/ or published in the members’ area of the EQPA Website.