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. It is recognized that local production is 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) is organizing a third edition, called Virtual cGMP Advanced 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.
Organization and content
This Virtual cGMP Training Marathon focuses on current interpretations and regulatory expectations of selected GMP topics on facility design, aseptic processing, and technology transfer, aiming at developing Quality Management Systems (QMS) skills to achieve a sustainable GMP compliant environment. The Virtual cGMP Training Marathon has a new and innovative design with two parts, as follows:
Part 1- GMP Training Marathon
It includes 8 training sessions, twice per week, starting from November 8th to December 1st. The virtual lectures will include real world examples, case studies and common cGMP deficiencies found in the field, and the possible approaches to manage or prevent them. Selected topics will include for example Facility Design; Quality Risk Management (QRM); Upstream and Downstream manufacturing processes; Technology Transfer; Process validation. Q&A sessions will be conducted at the end of each session.
Considering this course is advanced, it is strongly recommended that participants refresh GMP concepts. Participants should attend all sessions to fully benefit from the training marathon and see how the topics are interconnected.
Part 2- GMP Training Marathon
Part 2 is a hands-on workshop to develop QMS skills for up to 40 participants who will carry out a group project work on real-life case studies, based on CAPA and QRM tools (e.g., Fish Bone Diagram and FMEA). The case studies are related to the knowledge gained in Part 1.
Part 2 is divided in three virtual sessions, from December 6th to 8th, 2022, for up to 40 participants. Participants will be divided in 4 groups (up to 10 participants per group) in such a way that a diversity of professional backgrounds and experience are represented. Each group will work separately in virtual breakout sessions to carry out the assignment, which include the preparation of a brief presentation of the work done. The third and last session will be dedicated to present the group’s case study to the rest of the participants, interact and discuss. Full involvement and active contribution of each of the group’s members is expected during the 3 days.
A workshop examination to evaluate the participant’s knowledge and a survey for feedback will be carried out on-line after the closure of the training marathon.
Participants who attended all sessions and complete the examination and survey will receive a certificate of attendance.
Target Audience
Experienced Technical staff working in Production, Quality Assurance, Validation, Engineering, and Quality Control of vaccine/biopharmaceutical manufacturing plants and prospective vaccine manufacturing plants would benefit from this training marathon. Officers from National Regulatory Agencies and relevant government ministries/institutions are welcome to register interest to attend. As Part 2 is to build QMS skills in a manufacturing facility, priority will be afforded to technical staff working in a manufacturing plant.
Registration process
Registration of interest to participate in Part 1 and 2 is required. It is performed online by registering either for Part 1 only or for Part 1 and 2. All registrations of interest will be reviewed. Only selected registrants will receive a link for participation. The links for Part 1 and for Part 2 will be sent separately.
The selection process for attendance to Part 2, will be based on the following:
• full attendance to all 8 topics and examination score in Part 1
• professional background in their organizations (refer to Target Audience section)
• position in their organizations (priority will be afforded to positions with authority to implement changes, e.g. supervisors, managers)
• consideration of gender balance
• registration of interest is received before the deadline of 2 November
• the participant works in a manufacturing facility (priority will be afforded in decreasing order: vaccine manufacturer, biopharmaceutical manufacturer, prospective vaccine manufacturer)
• the vaccine manufacturing facility is located in a LMIC (priority will be afforded to manufacturers in Africa)
• there is at least one identified corrective and preventive action (CAPA) that the participant’s organization needs to implement
• other considerations to address public health priorities and/or needs of Member States
Due to the limited space, participants who registered and are eligible for Part 2 but are not selected for this training marathon will be granted priority for similar future hands-on training workshops in their respective country/region.
To register your interest to participate to Part 1 only or to Part 1 and 2, click on the link below. The deadline for registration is 2nd of November 2022. REGISTRATION: Virtual cGMP Training Marathon for Vaccine Manufacturing