Virtual cGMP Training Marathon for Vaccine Manufacturing: Sustaining a GMP Compliant Environment | So Good News

Many low- and middle-income countries (LMICs) in need of quality-assured vaccines depend on imports and are vulnerable to inconsistent supplies of such products. Local production ensures timely access to quality and reliable vaccines. It is recognized as one of the strategies to prevent shortages and stockouts and to protect health security.

After running a successful Virtual cGMP training marathon in 2020 and 2021; WHO Local Production and Assistance Unit (LPA) Titled Third Edition. Virtual cGMP Advanced Training Marathon for Vaccine Manufacturing: Maintaining a GMP compliant environment., In relation to Member States’ requests for advanced capacity building to address challenges and comply with current Good Manufacturing Practices (cGMP) and regulatory requirements.

Organization and Content

This Virtual cGMP training marathon aims to develop quality management systems (QMS) capabilities to achieve a sustainable GMP compliant environment, including plant design, Focuses on current interpretation and regulatory expectations of selected GMP topics related to sterilization processing and technology transfer. The Virtual cGMP Training Marathon features an innovative new design in two parts;

Part 1: The GMP Training Marathon

Includes 8 training sessions twice a week from November 8th to December 1st. real-world examples in virtual lectures; It will include case studies and common cGMP deficiencies found in the field and possible ways to manage or prevent them. Selected topics include, for example, Facility Design. quality management (QRM); upstream and downstream manufacturing processes; technology transfer; Process validation. Question and answer sessions will be held at the end of each session.

Considering this course is an advanced course, participants are strongly recommended to refresh their knowledge of GMP concepts. Participants should see how the topics are interconnected to get the most out of the training marathon.

Part 2: The GMP Training Marathon

Part 2 is a hands-on workshop to develop QMS skills for up to 40 participants who will conduct real-life case studies based on CAPA and QRM tools (e.g., Fish Bone Diagram and FMEA). Case studies relate to the knowledge gained in Part 1.

Part 2 from 6th to 8th December 2022 It is divided into 3 parts. Participants will be divided into 4 groups (up to 10 participants per group) in a manner that represents a variety of professional backgrounds and experiences. Each team will work separately in virtual breakout sessions to complete the assignment. Includes preparation of a summary presentation of work done. The third and final meeting was to present the team’s case study to the rest of the participants. It will be dedicated to mutual discussion. Full participation and active contribution from each member of the team is expected within 3 days.

After the training marathon closes, there will be a workshop test to assess the knowledge of the participants and an online survey for feedback.

After attending all courses and completing the exam and survey, you will receive an attendance certificate.

Target audience

Production quality assurance; Being right Engineers and experienced staff working in vaccine/biopharmaceutical manufacturing facilities and potential vaccine manufacturing facilities will benefit from this training marathon. Officials from national regulatory agencies and relevant government ministries are interested in attending. Since Part 2 is to build QMS skills in a manufacturing facility; Preference will be given to technical personnel working in the manufacturing plant.

Registration process

Those interested in participating in Part 1 and Part 2 are required to register. This is done online by registering for Part 1 only or for Part 1 and 2. All registrations of interest will be reviewed. Only selected subscribers will receive a link for joining. Links for Part 1 and Part 2 will be sent separately.

The selection process for admission to Part II will be based on the following:

• Full attendance of all 8 topics and test scores in Part 1.

• Professional background in their organizations (refer to target audience section);

• Positions in their organizations (preference will be given to positions with authority to implement change, eg supervisors, managers);

• Considering gender balance.

• Interest registration received by November 2nd.

• Participant works in a manufacturing facility (in order of decreasing priority: vaccine manufacturer, biopharmaceutical manufacturer, potential vaccine manufacturer);

• The vaccine manufacturing facility is located in an LMIC (preferably affordable for manufacturers in Africa);

• There is at least one identified corrective and preventive action (CAPA) that the participant’s organization is required to implement.

• Other considerations to address public health priorities and/or needs of Member States

Due to limited space, participants who have registered and qualified for Part 2 but are not selected for this training marathon will be given priority for similar hands-on training workshops in their respective countries/regions.

Click the link below to register your interest to participate in Part 1 only or Part 1 and 2. Last date to register is 2^n.d November 2022. Registration: Virtual cGMP Training Marathon for Vaccine Manufacturing

For more information, You can contact the LPA Unit Secretariat. [email protected]