16th Qualified Person Forum - With Pre-Conference Sessions on 01 December -
Registration Options for On-Site in Berlin, Live Online - or decide later

16th Qualified Person Forum - With Pre-Conference Sessions on 01 December -  Registration Options for On-Site in Berlin, Live Online - or decide later

Berlin, Germany

Seminar Nr. 18818

 

Kosten

Regular Fee: EUR 1690,--
EU/GMP Inspectorates: EUR 895,--
QP Member Discount: EUR 1490,--

Alle Preise zzgl. MwSt.

Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

Speakers from Authorities, Inspectorates and Associations:
Dr Rainer Gallitzendörfer, GMP Inspector, Germany
Dr Rainer Gnibl, GMP Inspector, Germany
Dr Thomas Hecker (invited), EDQM, Council of Europe
Mag.pharm. Andreas Kraßnigg, Austrian Agency for Health and Food Safety (AGES)
Gillian Renouf, Royal Pharmaceutical Society QP Assessment Panel, U.K.

Speakers from Industry:
Alexandra Bauloye, GlaxoSmithKline
Cheryl Chia, Lotus Phoenix Consulting
David Cockburn, EQPA
Dr Darrin Cowley (invited), AstraZeneca
Dr Susanne Ding, Boehringer Ingelheim
Dr Andreas Flückiger, Form. Roche
DI Georg Göstl, Takeda
Tor Gråberg, AstraZeneca
Dr Afshin Hosseiny, ECA
Patryk Jegorow, Takeda
Dr Ulrich Kissel, EQPA
Aidan Madden, FivePharma
Sue Mann, Sue Mann Consultancy
Gábor Mihályi, MihaPharm
Dr Peer Schmidt (invited), AbbVie
Kristina Smith Hansen, MilCor Consulting
Niina Taylor, Pfizer
Brenda Van Assche, Janssen

(other speakers invited)

Zielsetzung

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

Hintergrund

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

Zielgruppe

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.

Q&A Session

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

Programm

Pre-Conference Sessions - 01 December
 
Specific Requirements for IMPs (Full Day Session)
Facilitated by: Susanne Ding | Patryk Jegorow | Niina Taylor | Brenda Van Assche (other speakers invited)
  • New legislation impacting IMP QPs
  • Experiences with Brexit
  • Are you ready for the new IMP GMP regulation?
  • Inspector’s view on IMP Topics
  • Investigational ATMPs
  • Phase appropriate GMP
  • Interactive sessions and case studies – decision making of IMP QPs
  • Q&A sessions
Human Error (1/2 Day Session)
Facilitated by: Sue Mann | Kristina Smith Hansen
  • What is behind “Human Error”?
  • Considering human behaviours
  • Is Human error avoidable?
  • Tips for reducing human errors
How to certify Drug-Device Combinations (1/2 Day Session)
Facilitated by: Rainer Gallitzendörfer | Peer Schmidt (invited)
  • What the QP needs to know about the new Medical Devices regulations
  • Responsibilities of the QP when certifying DDCs (start and end)
  • How to prove compliance with medical device regulations and other requirements
  • Expectations of the Agencies
  • Interface to and co-operation with Notifi ed Body
  • Examples and experience made
QP Forum - 02-03 December 2021
 
Key Note: COVID-19 - the Challenge of making new Treatments available during Pandemic and dealing with missing Guidance
Darrin Cowley (invited)

General GMP Update – News for the QP besides the big Topics - Andreas Krassnigg
 
Annex 21: Consequences for the QP - Rainer Gnibl and Ulrich Kissel
  • Responsibility of the importing company and the QP
  • Batch testing and certifi cation
  • Contractual regulations
IMP QP at the Interface to commercial QP - IMP Working Group
  • Hand-over from clinical to commercial
Creating or Improving QP Oversight into the Supply Chain - Cheryl Chia and Afshin Hosseiny
  • How to understand Supply Chain Diagrams (SCD)
  • What the QP really needs and why
  • How to improve and implement SCDs
Brexit Implications for the QP - David Cockburn and Ulrich Kissel
  • UK and EU Point of View
  • Impact on the roles and responsibilities of the QP
Case Study: How to deal with severe Inspection Findings (“How not to lose your License”) - Gábor Mihályi
  • What had led to severe inspection fi ndings
  • What happened after receiving the inspection report
  • What to do and who to involve with the inspection remediation?
  • How was it aff ecting other sites?
Quality Risk Register/ Business Continuity Plan - Alexandra Bauloye and Aidan Madden
  • What is it, how to develop it and which type of risks to include
  • What to show to authorities?
  • The way to business continuity – what can the QP learn from this overall process?
  • Involvement of the QP (before things go wrong)
What to know about Threshold Levels for Impurities - Andreas Flückiger
  • How to deal with diff erent contaminants from a toxicological point of view
  • What do the limits mean? How are they set and how are they to be understood?
  • Why to know your toxicologist (Why the relationship with the toxicologist is important)
QP Scenarios – How serious could each Issue be? - Sue Mann and Gillian Renouf
  • Discuss real-life situations involving QPs
  • Explore the potential risks and impact
  • Make decisions on the product(s) involved
EDQM’s approach on Real Time Remote Inspections - Thomas Hecker (invited)
  • Results and impressions from EDQM’s real time remote inspection Pilot Project
  • Advantages/disadvantages of the approach and it’s future use within EDQM’s GMP assessment system of API manufacturers
Discussion: Can Distant Assessments replace on-site Audits after the Pandemic? - Rainer Gnibl and Tor Gråberg
  • GMP Inspectorate and Industry Point of View

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