The World Health Organization's Local Production & Assistance Unit (LPA), with support from key stakeholders, is pleased to announce the upcoming fifth “Virtual cGMP Training Marathon for Vaccine Manufacturing: Institutionalizing Compliance and Continued Improvement.” This annual event aims to bolster the capacities of Member States in producing quality-assured vaccines, ensuring equitable and timely access, and fortifying health security worldwide.
Background
Access to quality-assured vaccines is a cornerstone of effective health systems and national immunization programs. However, many low- and middle-income countries (LMICs) face significant challenges in this area, often relying on imports that can be inconsistent. Strengthening local production capabilities is essential to overcoming these challenges.
Since 2020, the WHO LPA Unit has successfully conducted four Virtual cGMP Training Marathons, enhancing knowledge and preparedness among vaccine manufacturers globally. This year's marathon, themed “Institutionalizing Compliance and Continued Improvement,” will build on previous years’ successes by focusing on sustaining GMP compliance and fostering a culture of continuous quality improvement.
Objectives
The 2024 training aims to support LMICs in strengthening their local vaccine manufacturing capabilities. By providing in-depth knowledge on current GMP standards, regulatory updates, and technological advancements, the training seeks to empower manufacturers and regulators to meet and exceed international quality benchmarks.
Key Topics
- Bio-Analytical Method Development and Validation for Biologicals
- Quality Risk Management Framework: A Proactive, Data-Driven Approach
- Process Validation of Biologicals: Current Regulatory Expectations
- Maintaining and Improving Process Performance: Monitoring and Trending
- Sterile Manufacturing: Navigating TRS 1044 Annex 2
- Technology Transfer Essentials for Bio-Pharmaceuticals
- Management of GXP Outsourced Activities: Challenges and Strategies
- Maintaining Compliant Critical Utilities from URS to PQ
- CAPA and RCA Investigation Management: Improving Effectiveness
- Recent cGMP Inspection Trends: Common Non-Compliances and Pitfalls
These sessions will be delivered virtually twice per week from September 10th to October 10th, 2024; 13:00 – 15:30 CEST, combining lectures, real-world examples, exercises, and case studies to ensure practical understanding and application of cGMP principles.
Participation
The training is open to professionals involved in vaccine, biological, and pharmaceutical manufacturing, particularly those from LMICs. Participants will have the opportunity to enhance their skills, adapt to regulatory changes, and implement effective quality management systems. Registration is required, and space is limited. Priority will be given to eligible participants from LMICs and those with active plans for WHO prequalification/EUL.
Register Now
To express your interest in participating, click here to register (Deadline: 6th September 2024). Selected participants will receive a confirmation email. For further inquiries, please contact the LPA Unit Secretariat at localproduction@who.int.