GMP and Quality Requirements for Radiopharmaceuticals - Online Training Recording
Course No. 19233A
Speakers
Dr Franz Schönfeld
Regierung von Oberfranken
Arjan Langen
GE Healthcare
Prof. Dr. Gerald Reischl
Universität Tübingen
Prof. Dr. Clemens Decristiforo
University Hospital Innsbruck
Dr. Jacek Koziorowski
RadCad
Dr. Nicholas Gillings
Copenhagen University Hospital, Rigshospitalet
Objectives
During this Live Online Training, 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 Qualification, Validation, Monitoring and Good Distribution Practice and more with a special focus on Radiopharmaceuticals.
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 course 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.
Technical Details:
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration: When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate: The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
Programme
Regulatory Requirements for Radiopharmaceuticals
Directive 2001/83/EC
Regulation EU No 536/2014
EU GMP Guidelines and their annexes 1, 3 and 13
Guidance documents
Rooms and Personnel – GMP Requirements for Product Safety
Design and qualification of facilities
Containment vs. contamination control
Training, qualification and monitoring program
QRM Principles – the Modern Way for QA
Pharmaceutical Quality System, QRM, and risk assessment(s)
Quality Risk Management (QRM) in manufacturing of sterile medicinal products
Major changes of Annex 1 (draft) regarding QRM principles
From Equipment Qualification to Process Validation
Annex 15 and its key elements
How to consider user requirements
Equipment and hot cell qualification
Process validation requirements
Radiation Protection and Personnel Safety Requirements
Regulatory requirements
General concepts and workflow
Constructional realization in a cleanroom environment
Waste handling
IMPD Issues
Chemical pharmaceutical data
Drug substance
Medicinal product
Non-clinical pharmacology, pharmacokinetics and toxicology
Clinical data
Benefits and risks assessment
Requirements on Data Integrity
Regulatory Background
Quality and manufacturing sections to be adjusted for DI
Critical steps in manufacturing
DI assessment of computer systems
How to Handle Audits- a Manufacturer’s Experience
Hot cell issues
Monitoring and Validation
Process Validation
Data integrity
Miscellaneous audit findings over the years.
Microbiological Control – from Sterility to Endotoxins
Regulatory Requirements vs. small batch size and short shelf life
Challenges and benefits of modern micro methods
Parametric Release
Pharmacopeia methods for endotoxin testing (Ph. Eur. 2.6.14)
LAL kinetic chromogenic methodology for rapid detection of endotoxins
LAL used for Radiopharmaceuticals
LAL method validation and data processing
Supplier Qualification
Legal Framework
Active pharmaceutical ingredients
Supplier selection
Supplier Evaluation
Approved suppliers
Quality Agreement
Data integrity
Validation of Analytical Methods
Regulatory Background
Guidelines and definitions
Specific application to Ph. Eur. methods
Additional aspects for Radiopharmaceuticals
Cleaning and Disinfection Requirements
General GMP requirements on cleaning and disinfection
Traditional disinfectants and new methods
Validation of disinfection procedures
Monitoring Requirements
Regulatory requirements on Monitoring
Qualification and routine Monitoring
Alert and action levels
Trending of data
GDP - a Special Challenge
The revised EU Guidelines on Good Distribution Practice (GDP)
Who is responsible for maintaining product quality in the supply chain
Key challenges and risks to consider
Cold Chain and ambient storage and Transportation
Role of the Responsible Person (RP)?
Special Challenges - Transportation under quarantine status – in bond shipment
Recording from 22/23 March 2022
Duration of Recording: 10 h 16 min
This course is part of the GMP Certification Programme "ECA Certified Quality Assurance Manager" Learn more
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