Target Group
- Quality control
- Quality assurance
- Inspection and audits
- Qualification and validation
- Radiopharmaceutical preparation and/or manufacturing.
Objectives
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.
Programme
- Directive 2001/83/EC
- Regulation EU No 536/2014
- EU GMP Guidelines and their annexes 1, 3 and 13
- Guidance documents
- General monographs and chapters in relation to radiopharmaceuticals
- Chemical precursors and radionuclides for radiolabelling
- New developments on therapeutic and PET radiopharmaceuticals
- “Sterile” – How, what and why?
- Risk management and CCS approaches for implementation
- Annex 1 Vs. Annex 3
- Design and qualification of facilities
- Containment vs. contamination control
- Training, qualification and monitoring program
- 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
- Design and qualification of facilities
- Containment vs. contamination control
- Training, qualification and monitoring program
- Regulatory requirements
- General concepts and workflow
- Constructional realization in a cleanroom environment
- Waste handling and exhaust
- General GMP requirements on cleaning and disinfection
- Traditional disinfectants and new methods
- Validation of disinfection procedures
- Phases of Equipment Qualification
- Principles of Process Validation
- Case studies and Industry Best Practices
- Regulatory Background
- Guidelines and definitions
- The “UNTIE®” process
- Specific application to Ph. Eur. methods
- Additional aspects for radiopharmaceuticals
- Benefits
- Overview of Methods
- Growth dependent
- Growth Independent
- Validation and implementation
- Future challenges
- Analysis of precursors, radionuclides and excipients
- Tests of the finished products: Purity, sterility and extractables & leachables
- Regulatory requirements on Monitoring
- Qualification and routine Monitoring
- Alert and action levels
- Trending of data
- Legal Framework
- Active Pharmaceutical Ingredients
- Supplier selection
- Supplier Evaluation
- Approved suppliers
- Quality agreement
- Data integrity
- Hot cell issues
- Monitoring and validation
- Process validation
- Data integrity
- Miscellaneous audit findings over the years
Further Information
Venue
Radisson BLU Scandinavia Hotel
Amager Boulevard 70
2300 Copenhagen, Denmark
Phone +45 33 96 50 00
Email info.cphza@radissonblu.com
Accommodation
CONCEPT HEIDELBERG has reserved a limited number of rooms in the conference hotel. You will receive a room reservation form/POG when you have registered for the conference. Reservation should be made directly with the hotel. Early reservation is recommended.
Social Event
On the evening of the first course day, the participants are cordially invited to a dinner. This event is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
Fees (per delegate, plus VAT)
ECA Members € 1,890
APIC Members € 1,990
Non-ECA Members € 2,090
EU GMP Inspectorates € 1,045
The conference fee is payable in advance after receipt of invoice and includes dinner on the first day, lunch on both days and all refreshments. VAT is reclaimable.
Presentations/Certificate
The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site. After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
Contacts
Questions regarding content:
Mr Clemens Mundo (Operations Director), +49 (0) 6221/84 44 42, mundo@concept-heidelberg.de
Questions regarding organisation:
Mr Niklaus Thiel (Organisation Manager), +49 (0) 6221/84 44 43, thiel@concept-heidelberg.de
Date & Time
(Registration/coffee 8:00 – 8:30 h)
Wed, 18 March 2026, 8:30 – 16:00 h
All times mentioned are CET
Costs
| ECA-Member*: | € 1890,- |
| Non ECA Member*: | € 2090,- |
| EU/GMP Inspectorates*: | € 1045,- |
| APIC Member Discount*: | € 1990,- |
(All prices excl. VAT). Important notes on sales tax.
not available
not available
This course is part of the GMP Certification Programme "ECA Certified Quality Assurance Manager"
Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org
Testimonials
