Statistics for Bioassays:

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)

FREE Session 1!!

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 Bioassays:

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)

FREE Session 1!!

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.

Tools for Quality Control Professionals:

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)

FREE Session 1!!

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 Course:

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)

FREE Session 1!!

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.

• Our online training sessions are 60 or 90 minutes.
• You’ll save time and money by cutting out travel and train from your computer.
• Courses are interactive with the instructor.
• Courses are taught by the best instructors–experienced and active industry professionals who will make your training interesting as well as informative.
• All courses include an electronic copy of the session slides.
• Our courses are one of the lowest costs in the industry so you can maximize your training budget.