FasTrain provides professional training for bio/pharmaceutical and biotech professionals. Our courses are designed to meet FDA, EMA and other regulatory agency training requirements. Click on the links below to learn more about each individual course that we offer.
This course is designed for anyone who works in the biopharmaceutical industry. Although it is useful for the “troops in the trenches” who use mathematical models in their everyday duties, it is intended also for their supervisors all the way up the company structure who must understand the concepts to make proper managerial decisions, especially when dealing with regulatory agencies or when improvements in processes are required.
This course is designed for anyone who works in the biopharmaceutical industry. Although it is useful for the “troops in the trenches” who will carry out the actual SPC calculations, it is intended also for their supervisors all the way up the company structure who must understand the material to make proper managerial decisions, especially when improvements in processes are required.
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. This is our favorite and longest running course. The “Must Attend” course for bioassay professionals!
This course is designed for biopharmaceutical professionals at all levels involved in changes during the manufacturing process or product development. Regulatory agencies require evidence to confirm that the process controls in the modified process provide at least similar or more effective control of the product quality, safety, and efficacy compared to those of the original process. There is no need to be a statistician to take this course! If you have a working understanding of basic statistics this course will take you to the next level.
This practical course is for everyone who deals with cultured mammalian cells. Absolute beginners but also experienced cell culture enthusiasts will benefit from this training. Scientists and technicians working in assay development or routine potency testing should attend, as well as lab managers overseeing the cell depository and cell banking activities.
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. The second half presents special topics relevant to potency bioassays. This course is the key to understanding and implementing the expected statistical tools for any new potency assay being submitted to any regulatory agency in the world.
This course is intended to build a solid understanding of the (admittedly large) collection of simple ideas that when combined, make bioassay designs and analyses work amazingly well. Many of these core concepts are statistical ideas; they will be explained, illustrated with examples, and reinforced as they are combined. A primary goal of this course is to help those who are developing, validating, managing, or maintaining bioassays better prepared to work with statisticians and data analysis experts.
This is a recommended annual training course structured as continuation of Potency Bioassay Development & Validation Training course by Dr. Laureen Little. This course is meticulously designed to provide comprehensive education to lab personnel and managers of biopharmaceutical companies and CRO/CTL’s 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.
This is a recommended training course 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. This course is recommended for analytical and formulation scientists as well as quality and regulatory professionals responsible for Chemistry, Manufacturing and Controls (CMC).
This course is recommended for professionals involved in drug development who work within, or adjacent to, CMC functions, including scientists, engineers, regulatory affairs personnel, consultants, and project managers. It is also recommended for researchers and academics seeking to expand their knowledge of CMC strategy and operations for biopharmaceutical development.
This is the course we wish we 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 take run a Quality Control Laboratory in a Bio/Pharmaceutical Company.
We work in a highly regulated environment, which entails biennial inspections from the regulatory authorities. These regulations exist to keep our pharmaceuticals safe and healthy. The regulations, the cGXPs, are at the same time; specific, vague and interpreted differently across the years. To instill a compliant culture at your facility, it is recommended that all your personnel receive cGXP training annually. However, let’s face it, this training can be dull, a bit point-missing and do a poor job at engaging your audience. This eight-session course is designed to train and engage. It covers the basic regulations, but really brings out the c(urrent) in cGXP by discussing case studies and giving specific tips and examples. And best of all, a test is available for all attendees. Once this is passed (80% correct), each attendee can be awarded a completion certificate for their training file.
This is a course designed for any person working in an FDA-regulated bio/pharmaceutical company. This includes all departments (manufacturing, analytical, quality, warehouse/shipping, development teams) and all levels from your most junior to the most senior staff. For more details on the topics covered in this single 120-minute session, please click the Learn More button below.
FDA HCT/P audits are common and becoming more problematic. Don’t be caught unprepared. Make sure all your employees are aware of these regulations and realize how it impacts their work. We work in a regulated environment. These regulations exist to keep our HCT/Ps safe and free from microbial contamination and infectious diseases. The regulation, 21CFR Part 1271, is the keystone to keeping our donated cells and tissues safe. In this course, we will describe the regulatory law, the history behind it and, more importantly, the scientific rationale of these regulations. We will discuss the regulations and provide tips on how to implement these regulations in a practical format. This will be done in an interesting fashion with many real examples and case studies. This course will help create a culture of compliance at your facility. It is recommended that all your personnel receive regulator training annually and this 3 x 1-hour session course will fulfill this requirement.
The Good Manufacturing Practices regulations exist to keep our pharmaceuticals safe and healthy. It is never too soon to start training your staff about these critical rules. The regulations, the cGMPs, often feel foreign to individuals working in a product development setting, as if they are designed for “those commercial” folks and not for us.
This course will help streamline your BLA applications down the road and is designed to improve the understanding of the cGMPs, explaining how these critical regulations apply to early stage development companies. This is important today, as the citations and problems with Application Integrity are escalating. It will help create a culture of compliance without impeding your creativity.
We will outline the requirements and provide hands-on tips about how to comply without stifling the very act of development. We focus on change capture rather change control, discuss current best practices and regulations needed for safety.
It is recommended that all your personnel receive cGXP training annually.
This is the course we all 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 take run a Quality Control Laboratory in a Bio/Pharmaceutical Company.