Live Online Joint PEI/ECA Workshop: GMP Compliant Manufacturing of COVID-19 Vaccines
10/11 March 2021
Course No. 18832
Speakers
Dr. Jörg Weyermann
GSK Vaccines
Robert G. Schwarz
GXP-TrainCon
Dr. Rainer Gnibl
GMP Inspektor, Regierung von Oberbayern
Dr. Jürgen Blattner
BSR
Peter Kralinger
Carrymed
Dr. Volker Öppling
Paul-Ehrlich-Institut
Dr. Marcus Fido
Mfi Bio-Consulting
Dr. Andreas Neubert
Klocke Holding
Objectives
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.
Background
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.
Target Group
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
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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
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
This course is part of the GMP Certification Programme "ECA Certified Biotech Manager" Learn more
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Seminar Programme as PDF