Radiopharmaceuticals – Quality, Safety and GMP Requirements

Radiopharmaceuticals – Quality, Safety and GMP Requirements

Vienna, Austria

Course No 16937


Costs

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Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Kathrine Ask Asmussen, Danish Medicines Agency
Dr Hendrikus Boersma, University Medical Center, Groningen
Dr Istvan Boros, University of Cambridge Wolfson Brain Imaging Centre
Jan van den Bos, GE Healthcare
Robert Hebel, PPH
Stefan Kürpig, University Hospital Bonn
Dr Gerald Reischl, University Tübingen
Dr Antonia Richter, University Hospital of the Technical University Munich
Markus Roemer, comes compliance services
Dr Christian Schmidt, Life Molecular Imaging GmbH
Dr Franz Schönfeld, Government of Upper Frankonia
Dr Ingrid Walther, Pharma Consulting Walther

Objectives

During this conference, representatives of regulatory authorities will present the current development of radiopharmaceutical regulations and their experiences during the inspection of manufacturing establishments including the possible impacts of the new Annex 1 .

Furthermore, speakers from nuclear medicine departments from universities and hospitals
as well as from industry will share their experiences with GMP implementation. You will become acquainted with possible solutions for the special challenges and practical approaches on room qualification for GMP-compliant manufacturing. They will cover the really “hot topics” in the world of pharmaceutical QA and QC like Computer Validation, Data Integrity and Good Distribution Practice.

The speaker team is set up to provide you with the unique possibility to discuss the current status and the future expectations with representatives of national authorities as well as professionals from universities, hospitals and engineering.

Background

The manufacturing of radiopharmaceutical products confronts the producing establishment with a collection of challenges. On the one hand, there is the challenge by the contradictory requirements of quality and safety guidelines of pharmaceutical products and the standards of staff safety and radiation protection. On the other hand, there are issues of small batch sizes and short shelf life. The short shelf life necessitates fast transportation and application to the patient. These circumstances mean that classical requirements like sterility testing before release and application cannot be fulfilled and GDP is a real challenge.

Target Group

This conference is aimed at the personnel of hospitals, pharmaceutical companies, their suppliers and authorities who are involved in

  • Quality Control
  • Quality Assurance
  • Inspection and Audits
  • Qualification and validation
  • Radiopharmaceutical manufacturing.aceutical manufacturing.

Programme

Current Regulatory Developments – Authorities‘ View

  • Directive 2001/83/EC
  • Regulation EU No 536/2014
  • EU GMP Guidelines and their annexes 1, 3 and 13
  • Guidance Documents
Radiopharmaceuticals and GMP – Practical Experiences
  • Possibilities and Limitations
  • Pitfalls
Quality Risk Management for Radiopharmaceutical Manufacturing
  • Quality Risk Management (QRM) in manufacturing of sterile medicinal products
  • Pharmaceutical Quality System, QRM, and risk assessment(s)
  • Most important changes of Annex 1 (draft) regarding QRM principl
es
From Old to New - Case Study on the Revision of an Existing Building
  • Important Questions – Pitfalls of the Project
  • Basic Conditions – What is to be observed?
  • Realisation - to make sure that nothing has been forgotten
  • Use – How to go on?
Supplier Management
  • Good Manufacturing Practice
  • Legal Framework
  • Active Pharmaceutical Ingredients
  • Supplier Selection
  • Supplier Evaluation
  • Approved Suppliers
  • Quality Agreement
GDP – The crucial role of Good Distribution Practice in the supply of Radiopharmaceuticals
  • Delivery to Customers – Customer Qualification
  • Route Qualification – Transport studies
  • Transportation under quarantine status – in bond shipment
  • Role of Responsible Person
Inspection Experiences and possible Impacts of Annex 1 Revision
  • The basis for radiopharmaceuticals (PET/TC Generator and Kit)
  • Inspections
  • Typical deficiencies
Annex 1/Sterile Manufacturing – We are ready?
  • Effective Root Cause Analysis
  • Education, not training
  • Use of Vapour Hydrogen Peroxide
  • PUFIT
  • Contamination Control Strategy document
Case Study: Audit Findings and their impact and the related GMP aspects
  • Hotcell issues
  • Monitoring and validation
  • Process validation
  • IMPD issues
  • Data integrity
  • Miscellaneous audit findings over the years.
Computer System Validation and Data Integrity – a chance for improvements
  • Lean Project & IT Management Approach - secure your investments
  • Data Mapping and Data Mining – secure your knowledge
  • GMP digitalisation – secure your future
  • Modern Validation Approach – secure your compliance
Bioburden Testing of Radiopharmaceuticals
  • Sample Frequency
  • Method of Sampling
  • How to define Specification
Validation of Analytical Methods
  • Regulatory Background
  • Validation Strategie

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