Save time and precious travel dollars and still get the best up-to-date training in the industry. Our multi-session courses are designed to give you all the information you need to get your job done.
Individual sessions are available too!
Check out our new courses and new biopharmaceutical Certification Program:
Instructor: Dr. Laureen Little
The December course sold out! Join us in January for the next live session!
When: Wednesday, 15 January 2025, 8am PT / 5pm CET
One x 120-minute session: $630. Excellent group discounts available!
Do you still need to fulfill your annual GXP training requirement? FasTrain’s Annual cGXP Update Course has been ongoing for over 15 years and is considered to be one of the best GXP courses offered. This is a 2-hour session covering cGXP basics and delves into how these regulations are being implemented in today’s environment. The course is educational, informative, and engaging. It is specifically designed to fulfill your annual cGXP training in a practical, easy to understand format.
A quiz is part of the live program, passing the exam will ensure prompt receipt of your Completion of uGXP Training Course Certificate
FasTrain’s Certification Program includes the real-life skills and knowledge that you need to work and thrive in the BioPharmaceutical Industry. Five levels of certification are available. Each level has three specific goals to complete with multiple course options available for each goal. Passing the exam at the end of each course ensures prompt receipt of your Certificate of Completion for that level to add to your training file and update your resume.
Get the training you need to move your career forward!
Instructor: Dr. Patricia Cash
When: Mondays & Wednesday, May 5, 7, 12, 14
8am PT / 11am ET / 5pm CET
Four x 60-minute sessions: $1356 (or $339 per single session)
This course is designed for anyone who works at a biopharmaceutical firm who wants to understand what is required in setting up a stability program, establishing expiration dates and other regulatory requirements related to stability and more!
Instructor: Dr. Anton Stetsenko
When: Early 2025 – Live session dates to be announced soon!
Five x 90-minute sessions: $1810 (or $362 per single session)
This course is meticulously designed to provide comprehensive education on the intricate technical aspects of relative format assays, such as immunoassays, enzymatic assays, and bioassays. The curriculum is structured to ensure participants gain a deep understanding of the key areas covered in each session.
Instructor: Dr. Stanley Deming
When: Early 2025 – Live session dates to be announced soon!
11 x 60-minute sessions, $3390 (or $339 per single session)
First session is FREE!!
This course provides a sound introduction to models used in bioassay, the simple mathematics used to fit these models to data, and the extraction of useful information from the fitted models. The teaching style leaves the participants with a deep understanding of correlation coefficients, Fisher F tests, the design of experiments (DOE), the concept of similarity (or parallelism), and other topics. The only mathematical tools required for the course are the ability to add, subtract, multiply, and divide (with the help of a calculator).
Here are a few new FasTrain Courses on the horizon in 2025:
Statistics for the Analytical Bench Scientist
Downstream Processing for CMC
Design of Experiments (DOE)
Ligand Binding Assays
Regulatory Pathways for Product Development
Each course is available immediately in on-demand recordings or sign up for future live-stream sessions.
Get the on-demand recordings now and complete your annual training needs.
Instructor: Dr. Laureen Little
Recordings from the most recent course available now!
Instructor: Dr. Laureen Little
Register now for the live stream course on 30 March 2023!
Instructor: Nancy Niemuth, M.S.
Recordings from the most recent course available now!
Instructor: Dr. Laureen Little
Recordings from the most recent course available now!
Instructor: Dr. David Lansky
Recordings from the most recent course available now!
Instructor: Dr. Laureen Little
Recordings from the most recent course available now!
Instructor: Dr. Oliver Wehmeier
Recordings from the most recent course available now!
Instructor: Dr. Laureen Little
Recordings from the most recent course available now!
Instructor: Dr. Denise Krawitz
Recordings from the most recent course available now!
Instructor: Dr. Laureen Little
Recordings from the most recent course available now!
Login to great bio/pharmaceutical training courses from anywhere in the world!Introduction to Statistics for Potency Bioassays Course Outline
Instructor: Nancy Niemuth M.S.
Painful memories of that required biostat course in grad school? Taught at an introductory level, this course presents basic statistics in plain English with examples related to potency bioassays to help you in your daily work. The first half of the course will cover introductory statistics, including ‘Statspeak’ or statistical terms & why they are important, descriptive statistics, statistical plots, hypothesis testing, ANOVA (1-way & 2-way), linear regressions and more. The second half presents special topics relevant to potency bioassays, such as: the 4PL model, USP guidance on system suitability and sample suitability, assay validation and more!
(Twelve x 60-minute sessions)
Session 1: StatSpeak-Statistical Terms & Why They Are Important:
This session will define key statistical terms, using relevant bioassay examples to illustrate these terms & why they are important. These concepts will provide you with a framework for understanding and applying statistics to real world problems!
Click on the button below to view to the FREE Session 1 recording.
Potency Bioassay Development & Validation Training Course Outline
Instructor: Dr. Laureen Little
This highly technical course is designed to speed up your development and validation of biological potency assays. Tricks of the trade, regulatory requirements and emerging trends are discussed in practical, no-nonsense terms, giving you a clear vision of how to design and implement bioassays. Scientific, regulatory and statistical tools are covered giving you a balanced, working knowledge of all aspects of these critical assays.
(Twelve x 90-minute sessions)
Session 1: Introduction to Potency Bioassays:
This session will bring you up-to-date on the current state of the bioassay and regulatory requirements for a potency-release assay. An overview of biological potency assays for various biopharmaceutical products, the quality paradigm for the test methods and the manufacture of their rare reagents will also be provided.
Click on the button below to view to the FREE Session 1 recording.
Practical Tools for the Quality Control Professional in the Bio/Pharmaceutical Industry Course Outline
Instructor: Dr. Laureen Little
This is the course we wish had been available at the beginning of our careers. It picks up where your university education stopped. It covers the regulations which govern the quality control lab, provides practical pointers for maintaining your laboratory in a compliant fashion and brings together the statistical tools you need to accomplish your daily work. Recent trends, emerging practices and the pitfalls to avoid are all highlighted in this hands-on course. You will walk away from this course prepared to run a Quality Control Laboratory in a Bio/Pharmaceutical Company.
(Twelve x 90-minute sessions)
Session 1: Regulations & Regulatory Trends:
This session will cover Regulations and Regulatory Trends and how they impact QC professionals on a daily basis. This session provides an overview of the GMPs as they pertain to the quality control professional. It serves as both an introduction to those new to the field and as a refresher for those with more experience.
Host Cell Protein for the Bio/Pharmaceutical Industry Course Outline:
Instructor: Dr. Denise Krawitz
FasTrain’s HCP Course covers everything you need to know to characterize and monitor host cell protein (HCP) in your process. HCPs are a unique and complex impurity present during the production of every recombinant protein therapeutic and critical to understand for patient safety. Learn about rapidly evolving technologies and health authority expectations for HCP characterization, and how to develop HCP immunoassays, characterize reagents at different phases on development. Recent updates on pharmacopeial guidance and recommendations are covered, and how to take a holistic approach to understanding HCP clearance from your process and the risk they pose to patients.
Recordings of each 60-minute session are available now!.
(Twelve x 60-minute sessions)
Session 1: Introduction to the Evolving Landscape of Host Cell Protein
This session will provide an overview of the HCP field: What are HCPs, the dynamics of HCP expression and why we need to monitor HCP during process development & manufacturing. Complete Session 1 Details: During production of biotherapeutics, manufacturers are required to control the host cell protein (HCP) impurities during the purification process. HCPs are a very complex process-related impurity that pose unique challenges for accurate monitoring and quantification. This session will serve as an overview of the HCP field where we will discuss what HCPs are, dynamics of HCP expression, and why we need to monitor HCPs during process development and manufacturing.
Click on the button below to view to the FREE Session 1 recording.
Did you miss the FREE Session 1: Introduction to Bioassays from FasTrain’s 2016 Online Bioassay Training Course?
You can now listen to it anytime at your convenience for FREE! Just click on the button to sign in on the GoToWebinar page. Sit back and relax for the next 90 minutes while Laureen Little discusses the current state of the bioassay and the regulatory requirements for a potency-release assay. She will also you give an overview of biological potency assays for various biopharmaceutical products, the quality paradigm for the test methods and the manufacture of their rare reagents.
