By Popular Demand: New Professional Development Courses Aim to Meet Industry Needs
Based on industry demand, MassBioEd has added three new professional development courses to its roster: Managing Clinical Trials, Drug Development for the Non-Scientist, and Investigations & CAPA.
The courses are open to anyone seeking to learn more about facets of the biotechnology industry, and employees of MassBio members companies receive discounts on registration. Some course attendees may also be eligible for grants from the state Workforce Training Fund.
MassBioEd is committed to the development of the current biotechnology workforce and aims to provide individuals with ways to better their education in the industry.
“MassBioEd courses offer such great diversity of both teachers and students that anyone in the industry can benefit,” said Laurie Halloran, President of Halloran Consulting Group and MassBioEd teacher.
Managing Clinical Trials
Managing Clinical Trials is a six-week evening program which aims to introduce the major skills needed to manage outsourced clinical studies within a CRO/sponsor environment. This course takes the place of the previously offered Overview of Clinical Research, but is a higher level course with a focus on management.
In an ever-growing industry, it becomes increasingly important to conduct factual, error-free trials with consistent results, making this course necessary for research and management professionals.
The course is aimed at those individuals with 3-5 years of experience in clinical trials or interest in becoming a manager. A combination of workshops and case studies will provide students with a comprehensive understanding of trial management at the end of the six sessions.
Drug Development for the Non-Scientist
This is a full day course of biotechnology information for non-science professionals working or looking to work within a science-based industry. Participants will receive an overview of the development and regulatory process for bringing a drug, either a small or large molecule to market.
This course takes an in-depth look at the steps required to take a product from the research lab to marketing approval, focusing on clinical, regulatory, and commercial aspects of development. Drug Development for the Non-Scientist can be beneficial for professionals in all sectors of biotech, pharma, and life sciences as well as policy makers, venture capitalists, consultants, PR specialists, university administrators, and many others.
This course is offered through BioTech Primer, which provides industry-experience professionals as educators and offers a fast-paced, engaging environment for professional development.
Investigations & CAPA
Investigations & CAPA is a one-day course designed to give the participant the background and knowledge needed to write a clear and concise audit-ready report.
Due to the nature of trials, errors can cost companies millions in lost batches, rework, and investigations. This course will show students how to clearly define the problem, investigate and conduct root cause analysis using simple tools, assess product quality/patient safety impact, design effective corrective and preventive actions, and package the report in a clear, concise, audit-ready manner.
“Investigations & CAPA is a fundamental quality system, perhaps the key safeguard for preventing errors,” says teacher Matt Peplowski. “Conducting and documenting root cause investigations is a must-have skill for all operations personnel.”
To register for courses, visit www.massbioed.org and click on “Courses” on the top menu.