Many low- and middle-income countries’ (LMICs) need for quality-assured
vaccines is dependent on importation and are at risk of a lack of consistent
supply of such products. Local production is viewed as one of the
strategies to improve timely access to quality-assured vaccine supplies, curb
shortages and stock-out and safeguard health security.
Following the successful Virtual cGMP Training Marathon in 2020
and 2021, WHO Local Production and Assistance Unit (LPA), with financial support from the Bill & Melinda Gates Foundation (BMGF), is organizing a third
edition, called Virtual
cGMP Training Marathon for Vaccine Manufacturing: Sustaining
a GMP-compliant Environment,
in respect to Member States' requests for advanced capacity
building to address challenges and improve compliance to current Good Manufacturing Practices (cGMP) and regulatory
requirements.
This training welcomes the participation of experienced technical staff working in Production, Quality Assurance, Validation, Engineering, and Quality Control of vaccine/biopharmaceutical manufacturing plants, particularly from LMICs. Regulators and relevant government ministries/institutions officers are also welcomed to join. This Virtual Training offers a new and innovative design with two parts:
- Part 1, an advanced course on cGMP, including lectures, case studies and Q&A sessions,
- Part 2, a practical and hands-on workshop section to develop Quality Management Systems (QMS) skills.
From the 8th of November to 1st of December 2022, Part 1 will take place and two topics
will be delivered each week to provide in-depth content focusing on advanced
concepts of selected GMP topics, technology transfer and facility design for vaccine manufacturing. On the 6th, 7th and 8th of December 2022, Part
2 is intended to fortify the training by applying pre-selected Quality Risk Management (QRM) tools to
tackle real-life GMP scenarios through hands-on group work.
For more information, please contact the LPA Unit Secretariat at: localproduction@who.int