|교육명||[USP Live Webinar] Introduction to GMP Manufacturing and Characterization of Vaccines for Human Use||분류||세미나|
USP India Education team is pleased to announce our upcoming live webinar on Introduction to GMP Manufacturing and Characterization of Vaccines for Human Use. Please be part of the same and share with your team so that they can be also be part of the same:
Introduction to GMP Manufacturing and Characterization of Vaccines for Human Use
Duration: 4 hours ( 2 hours each day)
Date: 24 & 25 February 2021, 03:00 p.m.–05:00 p.m. (한국시간 18:00 p.m.-20:00 p.m)
Course Fee: Free
For 24 Feb : Click Here and password is: Vaccines2021
For 25 Feb : Click Here and password is: Vaccines2021
This one-day course provides a general overview of manufacturing and characterization of vaccines including vaccine types, components, and functions. Fundamental concepts of good manufacturing practices (GMPs) will be introduced to participants. USP general chapters, International Council for Harmonization (ICH) and World Health Organization (WHO) regulatory guidelines, and vaccine standards developed by the WHO Expert Committee for Biological Standardization will also be addressed. Participants will engage in practical exercises and case studies to reinforce key learning points.
Upon completion of this course, you will be able to:
• Demonstrate a basic understanding of the types of vaccines and their components through discussion and recall activities
• Summarize and discuss the vaccine manufacturing processes
• Explain the fundamental concepts of GMPs
• Define SISPQ (safety, identity, strength, purity, and quality)
• Summarize the importance of the ICH and WHO
• Identify and explain ICH guidelines—Q5B, Q5D
• Explain ICH Q7, Q8, Q9, and Q10 as they relate to pharmaceutical quality systems (PQS)
• Demonstrate and apply knowledge of quality risk management and PQS through practical exercises and/or case studies
Who Should Participate
• R&D Cell Biologists • R&D Manufacturers • Research Scientists • Biotechnology Manufacturers • Pharmaceutical Microbiologists
Victor Maqueda, Biologist
Company: VICTOR G. MAQUEDA - Consulting Services
Education: Biologist & Professor of Biological Sciences
Thirty years of international, senior level experience in the pharmaceutical field in the private industry and as international auditor and consultant, as per WHO, US and EU standards.
Areas of expertise within the Pharmaceutical & Biologics Industries:
• Management of technical groups and projects
• cGMP's compliance of parenterals, vaccines, biologicals, API’s and medical devices (in vitro diagnostics – rapid tests).
• Start-up of new operations.
• Quality Assurance / Quality Systems / Quality Control
• Facility, Utilities & Equipment Qualification & Validation.
• ISO 9001; ISO 13485
• Training – Auditing – Consultancy for WHO and private industry
• Plant Design.
• GMP assessments, Due Diligence and Action Plans.
• Participation in WHO Prequalification process audits and follow-ups.
Professional experience as independent professional (since 1999):
• WHO external Auditor & Consultant. Since 2002 as external auditor, consultant and trainer for the World Health Organization, Geneva, to qualify UN suppliers of vaccines (Indonesia, China, India, South Korea, Europe, US, Canada, Russia and Brazil), and in-vitro diagnostics rapid tests for Malaria, HIV, Hepatitis (India, Japan). More than 30 audits for WHO Prequalification performed. Official WHO reviewer of WHO TRS (e.g., new GMP’s for Biological, TRS 999).