Introduction to Vaccines - CMC Regulatory and Quality Aspects
Course Director
Course Fee
$2650.00 Regular Registration
$2450.00 Early Bird Pricing (Register 30 Days in Advance)
Course Brochure
New brochure coming soon!
Future Live Stream Sessions (click to register)
Course Description
This course will introduce the attendee to the historical development of vaccines, the different types (classes) of vaccines in use today, and will orient the attendee to the laws (PHSA, FD&CA) and regulations (ICH, FDA Guidance’s) required for vaccine development and commercialization. The separate roles of FDA and CDC in the US will be discussed, and the regulatory pathways for marketing authorization (MAA) of vaccines in the EU will be presented.
The basic bioprocess steps to produce bacterial and viral vaccines will be discussed with a focus on global regulatory guidance (ICH) and FDA Guidelines of importance. Requirements imposed on vaccine CMC development and commercialization by the Public Health Service Act (PHSA) and the Food, Drug and Cosmetic Act (FD&CA) will be discussed. Quality control strategies for classes of vaccines will be presented.
An overview of the elements of the immune system will be presented and factors affecting the immune response to vaccines will be discussed. Immunological assays applied to certain vaccines in the measurement of quantity and potency will be highlighted.
We will conclude with an overview of therapeutic vaccine development strategies (vaccine types) regulated by CBER’s Office of Therapeutics and Advanced Therapies, followed by 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
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 regulation/Regulatory Guidelines, CMC development and quality assurance/control of vaccines for infectious disease or therapeutic indications. Typical attendees would include Regulatory Affairs, Quality, Product/Process Development and Project Management functions and Business Decision Makers.
The course can be customized to address specific organizational, departmental, or functional issues and delivered on site.
Certification Tracks
- (BDCP) Biopharmaceutical Development Certified Professional™
- (CMCCP) Chemistry, Manufacturing & Controls (CMC) Certified Professional™
- (CPVP) Certified Process Validation Professional™
- (GLPCP) Good Laboratory Practices (GLP) Certified Compliance Professional™
- (GMPCP) Current Good Manufacturing Practices (cGMP) Certified Professional™
- (GRACP) Global Regulatory Affairs Compliance Professional™
- (PDCP) Pharmaceutical Development Certified Professional™
Related Courses
- Analytical Method Validation for Biologics, Biopharmaceuticals and Other Therapeutic Products
- Cell and Gene Therapy Product Lifecycle - Introduction Course - Gene Editing, CRISPR/Cas, TALEN Technologies
- CMC Regulatory Compliance Strategy for Recombinant Proteins, Monoclonal Antibodies, & Biosimilars
- CMC Regulatory Compliance Strategy for Cell & Gene Therapy Medicines
- European Regulatory Procedures - Comprehensive Overview of EMA and National Requirements™
- Good Manufacturing Practices Training | GMP Course
- Preparation of FDA Submissions and Communicating with the FDA
- Preparing the CMC Section for NDAs/INDs/CTDs
- The Drug Development Process From Concept to Market
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.