Sprecher
Prof Dr Isabelle Bekeredjian-Ding, Paul-Ehrlich-Institute
Dr Jürgen (Ing.) Blattner, BSR Ingenieurbüro
Dr Markus Fido, MFI Bioconsulting
Robert Funcke, Infrasolution
Dr Rainer Gnibl, Government of Upper Bavaria
Dr Elena Grabski, Paul-Ehrlich-Institute
Dr Simone Kardinahl, IDT Biologika
Peter Kralinger, Carrymed Pharma & Transport
Dr Andreas Neubert, IDT Biologika
Dr Volker Öppling, Paul-Ehrlich-Institute
Stacey Ramsey, Charles River Laboratories
Robert Schwarz, Technical University Vienna
Dr Jörg Weyermann, GSK
Dr Jürgen (Ing.) Blattner, BSR Ingenieurbüro
Dr Markus Fido, MFI Bioconsulting
Robert Funcke, Infrasolution
Dr Rainer Gnibl, Government of Upper Bavaria
Dr Elena Grabski, Paul-Ehrlich-Institute
Dr Simone Kardinahl, IDT Biologika
Peter Kralinger, Carrymed Pharma & Transport
Dr Andreas Neubert, IDT Biologika
Dr Volker Öppling, Paul-Ehrlich-Institute
Stacey Ramsey, Charles River Laboratories
Robert Schwarz, Technical University Vienna
Dr Jörg Weyermann, GSK
Zielsetzung
The objective is to provide a training opportunity for unexperienced staff and a discussion forum for experienced personnel on specific COVID-19 vaccine-related questions. Next to the above-mentioned topics the invited speakers will cover GMP issues, microbiological and viral safety aspects, QC and environmental monitoring aspects as well as important regulatory issues and framework.
Hintergrund
Vaccine development and manufacturing are crucial for control of the COVID-19 pandemic. Platform technologies have enabled rapid development of vaccines with demonstrated efficacy against COVID-19. However, large-scale manufacturing is prerequisite for meeting the global demand. This implies upscaling of manufacturing, meeting GMP requirements and switching of manufacturing in existing facilities. The workshop organized by PEI and the ECA Foundation will address These topics and provide an overview on GMP for vaccines and practical insights from experts in the field.
Zielgruppe
This workshop is aimed at all persons involved in vaccine licensing and production:
- GMP compliance in manufacturing
- The necessary room and technical requirements
- Upscaling of manufacturing
- Upstream and Downstream
- Inspections and audits
- Quality control, quality assurance and release issues
Technical Requirements
For our Live Online Training Courses and Webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.
At http://www.webex.com/test-meeting.html you can check if your System meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and e-mail address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Programm
National, European, Old and New Responsibilities of the Paul-Ehrlich-Institute in Light of COVID-19
Regulatory GMP Requirements: Guideline Overview
- Requirements from drug law
- Applicable EU-GMP Guidelines
- GMP-Essentials for facility, equipment & process
HVAC Systems and Zoning
Part 1: GMP Compliance in Design and Construction
- Construction Requirements
- Technical Solutions
Part 2: Zones and Ventilation Concepts in the Clean Room
Dr Jürgen Blattner, BSR Ingenieurbüro
Dr Jürgen Blattner, BSR Ingenieurbüro
- Zoning and pressure cascades
- Minimum requirements
- Combination of product and personal protection
Design and Qualification of Production Lines
Containment, Biological Safety and Product Protection
- Containment, product safety versus environmental safety
- Primary containment and additional measures
- Negative pressure areas in aseptic manufacturing
- Decontamination of facilities
- Personnel as critical component in Containment
Temperature-Controlled Transports of Medicinal Products
- Insulated packaging for small and large quantities
- Road transport and air freight of cold chain products (2 – 8 °C)
- Transport and storage at ultra-frozen range (-70 °C)
Development of Regulatory Requirements for COVID-19 Vaccines in an Emergency Situation – Focus on Quality
Platform Based Approach for Fast Track Development and Upscale of Manufacturing of an MVA Vaccine Candidate
- IDT Biologika has been using its well established Technology platform to jump start development of an MVA-base Covid-19 vaccine
- Highlights and Challenges of transferring a candidate into early development and later on into clinical manufacturing for Phase I and Phase II are presented
- Fast Track Analytical methods as well as additional Extended characterization are supporting the development concept
GMP Issues for Upstream/Downstream Processing
- GMP requirements in manufacturing
- Issues and challenges during vaccine manufacturing
- New trends and techniques
COVID-19 Vaccines – Analytics & Process Transfer, Characterisation & Control
- Different vaccines – same goal
- Analytical product characterization during process development (USP/DSP)
- Product specification, release and stability
Microbiological Safety – Accelerating Implementation of Rapid Sterility for Lot Release Testing
- Alternative Method Validation Journey
- Overcoming hurdles for rapid method implementation
- Case studies for completed projects and regulatory Status
EU Control Authority Batch Release of Vaccines
- Principles of EU mutual recognition system
- Protocol review and testing by the agency
- COVID-19 related network activities
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