Draft 2014 Educational Programs:|
#1 Facility Optimization & Process Improvement
Engineers love to improve manufacturing plants. Biopharmaceutical quality policies encourage continuous improvement, yet the reality is once a production facility is licensed and a process approved, change is difficult. Needed is a cost-effective experimental facility, common in other industries, to effect changes that meet the requirements of quality assurance. Massachusetts has built the first such facility, the Massachusetts Accelerator for Biomanufacturing (MAB) at UMASS Dartmouth, to enable experimentation that can improve facility design and manufacturing processes. This seminar aims to introduce the MAB paradigm and show how engineersâ€™ dreams can now become quality-approved reality.
#2 Project Stakeholder Management: The Most Critical Success Factor for Any Project
This seminar will dispel the myth that stakeholder management only requires identifying who they are, understanding their interests, and keeping them informed of project progress. Whereas stakeholders often resist change and project managers must walk a tight rope in balancing their expectations with resources, negotiating tradeoffs and keeping them satisfied. Proactively managing stakeholders will increase the probability of project acceptance and lead to the adoption of the anticipated project outcome. In addition to delivering on cost, schedule and scope, new and seasoned project managers must learn how to embrace, engage, influence and successfully manage stakeholders.
#3 â€śHarder Than It Looksâ€ť â€“ Executing Retrofit Projects in Operating GMP Plants
Under the best circumstances proper execution of engineering projects for GMP use â€“ from simple tasks like adding a WFI drop to major process change or expansion â€“ is complex. When the project must be undertaken while GMP operations carry on in adjacent spaces, new layers of complexity arise from having to prove that no impact to product-in-process and maintaining the production schedule. This seminar will examine the unique impact of concurrent manufacturing on project execution for each principal phase of a retrofit project: Design, Planning, Execution and Return-to-Service as well as offer tips, tools and lessons learned.
#4 Biotech 101
This seminar will introduce the principles and techniques of biomanufacturing and how human therapeutic products are made from living cells and their components such as bacteria and enzymes. One of the fastest growing industries in the world, Biotech incorporates the expertise of life sciences, biological and chemical engineering. This seminar will examine what biologics are, how they are processed from a seed stock to a final product, incorporating manufacturing unit operations and critical parameters in a regulatory environment.