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Course Director

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Course Fee

$2650.00 Regular Registration

$2450.00 Early Bird Pricing (Register 30 Days in Advance)

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Future Live Stream Sessions (click to register)

Course Description

During this course on chemistry, manufacturing and controls (CMC) regulatory and quality aspects, we will introduce you to the historical development of vaccines. You will learn about the different types of vaccines in use today and explore the relevant laws and regulations required for vaccine development and commercialization. 

These include:

  • The Public Health Service Act (PHSA)
  • The Federal Food, Drug and Cosmetic Act (FD&CA)
  • The International Council for Harmonisation (ICH)
  • The U.S. Food and Drug Administration (FDA) guidance


The separate roles of the FDA and the Centers for Disease Control and Prevention (CDC) in the U.S. will be discussed. We will also present regulatory pathways for marketing authorization (MAA) of vaccines in the European Union.


What This Course Covers

In comprehensive vaccine CMC regulatory compliance training, we move beyond the basics to explore the intricate life cycle of vaccine products. We examine the specific requirements imposed on vaccine development regulatory pathways by the U.S. Department of Health and Human Services and other global health authorities.

Participants will learn about:

Vaccine Development and Compliance

This course discusses the basic bioprocess steps for producing bacterial and viral vaccines, with a focus on key global regulatory guidance. It also covers the requirements imposed by the PHSA and the FD&CA on vaccine CMC development and commercialization.

Vaccine Manufacturing Quality Control

Quality control strategies for vaccine classes will be presented, with a specific focus on manufacturing protocols that ensure batch-to-batch consistency. Participants will gain in-depth knowledge of biologic vaccine CMC requirements, including:

  • Master cell banks and viral seeds: Learn strategies for characterizing and maintaining the critical starting materials for vaccine production. These foundational materials require extensive testing and documentation to ensure consistent vaccine quality and regulatory compliance throughout the product life cycle.
  • Upstream and downstream processing: Understand best practices for managing impurities, sterility and yield in complex biological manufacturing environments. These processes require specialized controls and monitoring to maintain product quality while achieving commercial-scale production efficiency.
  • Analytical method validation: Master approaches for validating the unique assays required for biological products, from enzyme-linked immunosorbent assay (ELISA) to polymerase chain reaction (PCR). These validation strategies ensure analytical methods can reliably measure critical quality attributes and support regulatory submissions for vaccine approval.

Immunology and Potency Testing

This course presents an overview of the elements of the immune system and discusses factors affecting the immune response to vaccines. It will also highlight immunological assays applied to certain vaccines for measuring quantity and potency. Additionally, you will learn the critical science of vaccine potency and stability testing, and how to design stability protocols that meet the stringent expectations of the FDA's Center for Biologics Evaluation and Research (CBER).

Modern Vaccine Technologies and Challenges

We will conclude with an overview of therapeutic vaccine development strategies (vaccine types) regulated by CBER’s Office of Therapeutics and Advanced Therapies. We will also take a more in-depth look at some vaccines developed globally to address the COVID-19 pandemic, with an examination of the unique production methods and drug product formulation requirements for the new class of mRNA vaccines and a view of the associated control testing of these products.

Who Should Attend Vaccine CMC Regulatory Compliance Training?

This 20-hour course is designed for senior management, directors, managers, supervisors, project planners and professional staff seeking to obtain a broad understanding of vaccines and the regulatory guidelines, CMC development and quality assurance and control of vaccines for infectious disease or therapeutic indications.

Professional Roles

Typical attendees include:

  • Regulatory affairs professionals
  • Quality professionals
  • Product and process development scientists
  • Project management specialists
  • Business decision-makers


Applicable Industries

This training is essential for professionals working in:

  • Vaccine manufacturing companies
  • Biotechnology and biopharmaceutical organizations
  • Contract development and manufacturing organizations (CDMOs)
  • Pharmaceutical companies
  • Government agencies and public health organizations
  • Academic research institutions
  • Regulatory consulting firms
  • Contract research organizations (CROs)


The course can be customized to address specific organizational, departmental or functional issues and delivered on-site.


Join The Wait List Request On-Site Details

  • Learning Objectives

    This course provides a solid foundation to understand scientific, global regulatory principles and approval strategies of Cell & Gene Therapies. It allows to coAt the end of the three-day course attendees will:

    • Gain a solid understanding of the regulatory framework for vaccines for prophylactic (infectious disease) and therapeutic indications, incidents that have prompted regulation, and an understanding of the differences and commonalities of vaccine regulation versus small molecule drugs and other biologics. 
    • Understand the structure of CBER within FDA and its historical evolution, and the processes in place in EU for review and authorization of new vaccines. 
    • Understand the fundamental bioprocess steps in production of bacterial and viral (cell-based) vaccines and control testing requirements/strategies, including a basic understanding of Master Cell Banks, Master Viral Seeds, upstream and downstream processes, and testing/characterization of process- and product-related impurities and adventitious agents.
    • Gain an understanding of the elements of the immune system and its response to vaccines, and the use of basic immunological methods used in the quality control and characterization of vaccines.
    • Gain an understanding of the different types (classes) of prophylactic vaccines in commercial use, including live attenuated vaccines, inactivated bacterial and viral vaccines, subunits/toxoids, recombinantly produced vaccines and gene-based (mRNA) vaccines, and an understanding of approaches (vaccine types) being evaluated as potential therapeutic vaccines for conditions such as cancer.  
    • Understand the rapid development of COVID-19 vaccines through government funding (OWS, BARDA) and the current FDA requirements for Emergency Use Authorization (EUA) and full approval (BLA) of COVID-19 vaccines. Gain an understanding of different approaches undertaken by companies globally to develop COVID-19 vaccines and real-word safety experience, and understand the quality control strategies applied to these vaccines.

  • Agenda


    Historical Development of Vaccines

    • From smallpox vaccination to today’s new mRNA vaccines for COVID-19
    • Classes of vaccines (live attenuated, inactivated bacteria and viruses, toxoids and subunit vaccines, recombinant proteins/viruses and gene-based vaccines)High level view of vaccines in commercial distribution today
    • Progression of vaccines recommended for routine use, from 4 pediatric vaccines (1940s) to 15 vaccines today.

    Development of Vaccine Regulation

    • Early regulation of vaccines/biologics in the U.S., including a look at a horse named Jim 
    • Regulations evolve in parallel with traditional drugs, like the Public Service Health Act (PHSA) and the Food Drug and Cosmetic Act (FD&CA)
    • The “Cutter Incident” and other disasters spur regulation
    • Vaccine regulatory authority moves from NIH to FDA, which was more than just an administrative shift
    • What is a vaccine, anyway?
    • Current organization of CBER within FDA, including the Office of Vaccines Research and Review, Office of Tissues and Advanced Therapies 
    • MAA pathways in the EU for vaccines (Centralized Procedure, Decentralized and Mutual Recognition procedures)

    Immunization policy in the US and EU

    • Roles of CDC and ACIP, and FDA and VRBPAC in the US
    • Decentralized vaccination policy within the EU (vaccines used, routes of administration, vaccination schedules)
    • Vaccine production overview, including basic production processes for bacterial and viral vaccines

    Vaccine Production Overview – Basic Production Processes for Bacterial and Viral Vaccines 


    Fundamental process steps for vaccine production

    • A high-level view of upstream and downstream vaccine production processes
    • Examples of manufacturing process flows for a bacterial conjugate vaccine and an inactivated influenza vaccine
    • Master cell banks and master virus banks for vaccine production, ICH Q5B and Q5D and FDA Guidance on viral vaccines
    • Cell substrates used to produce licensed vaccines
    • Vaccine purity/impurities, including the process-related impurities, product-related impurities and adventitious agents, regulatory and quality considerations and ICH Q5A

    Vaccine Production Overview – Basic Production Processes for Bacterial and Viral Vaccines - continued 


    Requirements and Testing Strategies for Vaccines

    • Requirements imposed by PHSA and FD&CA
    • Review of 21 CFR 600-680 requirements pertinent to vaccines, including biological production deviation reports, establishment inspection and “Team Biologics”, VAERS reporting, vaccine lot release, biological potency testing and potency tests employed for different classes of vaccines
    • Requirements for vaccines and other drugs alike, including 21 CFR 200s, 300s and more 
    • Overview of ICH Guidelines and companion FDA Guidance relevant to vaccine development
    • Examination of ICH Q6B (Test Procedures and Acceptance Criteria) as applicable to vaccines
    • Some typical QC release testing plans for vaccines (bacterial, viral/cell culture based)  

    Basic Vaccine Immunology


    • Elements of the immune system: Innate and adaptive immune systems
    • Immune response to a vaccine: Characteristics of the immune response, factors affecting the response to a vaccine
    • Measuring the response to a vaccine in clinical trials and potency assays: Serum neutralization, antibody titer by ELISA
    • Other immunological tests for vaccines: Lf test to quantitate toxoids and SRID for flu vaccine potency
    • Adjuvants: Purposes, classes of adjuvants in vaccines and regulatory assessment of novel adjuvants (EU Guidance)   

    Therapeutic Vaccines

    • Distinction between therapeutic and prophylactic vaccines
    • Approaches to development of therapeutic vaccines for cancer: some hits and misses so far 

    A focus on COVID-19 vaccines:  vaccine development approaches to the pandemic

    • Overview of SARS-CoV-2 virus and COVID-19 disease, including recent history and development of “variants”
    • Operation Warp Speed funding of vaccine development and BARDA
    • FDA guidance on development of COVID-19 vaccines, including requirements for EUA and BLA approval
    • Vaccine development approaches, like inactivated whole viruses, subunits, mRNA, DNA and viral vectors 
    • A deeper look at mRNA vaccines, including the basic science of this new vaccine approach, structure of mRNA vaccines, in vitro transcription production and nanoparticle formulations
    • QC control strategies applied to mRNA vaccines

Registrant Information:

Each person attending a course will be asked to set up an Attendee Profile Account during the registration process. Creating an Account helps you view your order history and manage your training programs. If you are registering for others, please set up an Account in the Attendee’s name. If you are registering more than one person, you’ll need to set up a separate account for each Attendee.