GMP & GDP Forum 2021 - GMP & GDP Part (Day 2)
Im Auftrag der ECA Academy
Heidelberg, Germany
Seminar Nr. 18478
Unser Seminarservice
Kosten
| ECA-Member: | EUR 790,-- |
| Regular Fee: | EUR 990,-- |
| EU/GMP Inspectorates: | EUR 495,-- |
| APIC Member Discount: | EUR 890,-- |
| GDP Association Member Discount: | EUR 790,-- |
Alle Preise zzgl. MwSt.
Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de
Sprecher
Ib Alstrup, GxP IT Medicines Inspector with the Danish Medicines Agency, DMA, Denmark
Dr Christopher Burgess, Qualified Person, Chaiman ECA Quality Control Group, UK
Cheryl Chia, Lotus Phoenix Consulting, Netherlands
Prabjeet Dulai, GDP & Quality Matters, UK
Dr Rainer Gnibl, GMP Inspector, District Government of Upper Bavaria, Germany
Jochen Heinzel, F. Hoffmann-La Roche, Switzerland
Dr Afshin Hosseiny, Qualifed Person, Chairman ECA Foundation and European GDP Association, UK
Saddam Huq, GlaxoSmithKline, U.K.
Dr Ulrich Kissel, Chairman, European QP Association, Germany
Gert Moelgaard, Chairman ECA Validation Group, Denmark
Helga Peters, Switzerland
Axel Radke, Trust Expertenservice, Germany
Jonathan Riley, Astellas Pharma Europe Ltd
Dr Bernd Renger, Qualifed Person, Immediate Past Chairman European QP Association, Germany
Maria Sekamwa, Surgipharm, Uganda
Dr Franz Schönfeld, District Government of Upper Franconia, Germany
Dr Wolfgang Schumacher, Chairman ECA Data Integrity & IT Compliance Group, Switzerland
Lance Smallshaw, UCB Biopharma sprl, Chairman ECA Cannabis Group, Belgium
Dr Ingrid Walther, Pharma Consulting Walther, Former Head of the Business Unit iv Drugs, Fresenius
Dr Christopher Burgess, Qualified Person, Chaiman ECA Quality Control Group, UK
Cheryl Chia, Lotus Phoenix Consulting, Netherlands
Prabjeet Dulai, GDP & Quality Matters, UK
Dr Rainer Gnibl, GMP Inspector, District Government of Upper Bavaria, Germany
Jochen Heinzel, F. Hoffmann-La Roche, Switzerland
Dr Afshin Hosseiny, Qualifed Person, Chairman ECA Foundation and European GDP Association, UK
Saddam Huq, GlaxoSmithKline, U.K.
Dr Ulrich Kissel, Chairman, European QP Association, Germany
Gert Moelgaard, Chairman ECA Validation Group, Denmark
Helga Peters, Switzerland
Axel Radke, Trust Expertenservice, Germany
Jonathan Riley, Astellas Pharma Europe Ltd
Dr Bernd Renger, Qualifed Person, Immediate Past Chairman European QP Association, Germany
Maria Sekamwa, Surgipharm, Uganda
Dr Franz Schönfeld, District Government of Upper Franconia, Germany
Dr Wolfgang Schumacher, Chairman ECA Data Integrity & IT Compliance Group, Switzerland
Lance Smallshaw, UCB Biopharma sprl, Chairman ECA Cannabis Group, Belgium
Dr Ingrid Walther, Pharma Consulting Walther, Former Head of the Business Unit iv Drugs, Fresenius
Hintergrund
I would like to invite you to the European GMP & GDP Forum from 22 – 24 June 2021.
Our ECA members are familiar with biennial conferences on GMP and GDP we have been running for several years. However, we have now developed this unique Forum by combining the European GMP Conference and the European GDP Forum. I believe with this new event by combining both GMP and GDP subjects, we have created a new opportunity for you to meet delegates and expert speakers from across the industry, and exchange views and learn about the whole Pharma supply chain challenges.
We have dedicated day 1 to GMP, day 2 will be a combination of both GMP, and GDP and the nal day will be focussed on GDP topics only. - is will allow you as a participant to take advantage of the event based on your personal needs and interest in the speci c subject areas, you can now choose to attend the forum just for one of the three days, two days or all three days. We intend to host the Forum every two years which I am sure will become a major European event for GMP and GDP professionals. For our rst Forum in June 2021 we have invited speakers from Regulatory Authorities and Pharmaceutical Industry to share and discuss with you the latest GMP & GDP developments.
I look forward to meeting you either live online or in person in Heidelberg, Germany – one of the most beautiful cities in Europe!
Zielgruppe
The conference is of particular interest for GMP experts of pharmaceutical companies (e.g. QA, QC, production, regulatory a airs), of GMP inspectorates and Regulatory Authorities. It is also of interest for all personnel involved in GDP – pharmaceutical storage, transportation, cold chain and Distribution activities and the control of these activities.
Programm
Programme 23 June 2021 - GMP & GDP Part
Moderated by: Dr Urich Kissel
Brexit: Consequences for GMP and GDP Environment
Dr Afshin Hosseiny, Chairman ECA Foundation and European GDP Association
Dr Afshin Hosseiny, Chairman ECA Foundation and European GDP Association
- What is the impact of Brexit on Pharma Regulations?
- New GMP and GDP expectations from UK
- How Pharma Industry in EU should manage the UK Business
- What impact all this has on the patients?
EU GMP Annex 21: Import of Medicinal Products
Dr Ulrich Kissel, Chairman European QP Association
Dr Ulrich Kissel, Chairman European QP Association
- The meaning of importation within scope of Annex 21
- What is new in Annex 21 (dra )?
- What do we miss in Annex 21 (dra )?
- Conclusions and comments on the document
Parallel Sessions & Workshops with Inspectors
Option 1 (Validation Group): Quali- cation & Validation: Supplier integration – how does this fit with GMP?
Option 2 (Quality Control Group): QC: How sure are you that your Laboratory Instrument/System is fit for its intended Purpose?
Option 3 ( Data Integrity & IT Compliance Group): Data Integrity: Data Integrity in the GMP area
Option 4 (GDP Group): How to Identify and Manage Falsified Medicines in the Supply Chain
Option 5 (GDP Group): Risk Management in GDP Warehouse
Session
Inspections/Audits in Covid-19 Times
The corona pandemic causes unusual supplier quali cation activities. Meetings face-to-face are reduced or not possible at all. - is concerns supplier audits but also regulatory inspections. To ful l GMP-requirements and to prevent travelling and meeting people personally is a balancing act. How to react?
The corona pandemic causes unusual supplier quali cation activities. Meetings face-to-face are reduced or not possible at all. - is concerns supplier audits but also regulatory inspections. To ful l GMP-requirements and to prevent travelling and meeting people personally is a balancing act. How to react?
Distant Assessments – GMP-inspector´s view
Dr Rainer Gnibl, GMP Inspector
- Regulatory Basis
- Requirements from guidelines
- Examples from inspections
- Reliability in “real life”
Supplier Management during Covid-19 Pandemic
To be named
To be named
GMP Seminare nach Thema
- Qualitätssicherung / Dokumentation
- Regulatory Affairs and Compliance
- Entwicklung / Prüfpräparate
- Datenintegrität
- Qualitätskontrolle / Analytik / Statistik
- GDP - Lager - Logistik
- Computervalidierung
- Validierung / Qualifizierung
- GMP in Produktion / Technik
- GMP für Wirkststoffe und Hilfsstoffe
- Medizinprodukte und Kosmetika
- GMP Basisausbildung
- Packmittel / Verpackung
- Hygiene / Mikrobiologie / Steril
- Biotechnologie
- Einkauf / Betriebswirtschaft / Effizienz
- European Conferences and Education Courses
- Sonstige Themen