16th Qualified Person Forum - With Pre-Conference Sessions on 01 December - Registration Options for On-Site in Berlin, Live Online - or decide later
2/3 December 2021, Berlin, Germany
Course No. 18818
Speakers
Dr. Rainer Gnibl
GMP Inspektor, Regierung von Oberbayern
Georg Göstl
Takeda Manufacturing Austria
Dr Afshin Hosseiny
ECA
Dr. Ulrich Kissel
European QP Association (EQPA), KisselPharmaConsulting
Aidan Madden
FivePharma
Andreas Kraßnigg
AGES, Österreichische Agentur für Gesundheit und Ernährungssicherheit
Cheryl Chia
Lotus Phoenix Consulting
Alexandra Bauloye
GSK
Objectives
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.
Background
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.
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.
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.
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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Seminar Programme as PDF