Bruce Fieggen – has been managing projects in the Medical Device and Pharmaceutical fields for the last 25 years. After stumbling through his first few projects he was fortunate to be trained byCadence in some simple techniques to manage projects with less frustration. He has used those techniques since with great success.
About sixteen years ago, Boston University recruited him to teach their Project Management Certification Course. He has taught that multiple times, then customized it for the Pharmaceutical Industry and teaches it several times a year.
Meanwhile he became certified to teach the Cadence course and has taught thousands of happy students this course over the last fifteen years. His average evaluation is 4.8. This is on a scale where a 4 indicates they find his teaching Very Good and 5 means Excellent.
Bruce has created his own classes in project management that takes the best of all the courses he has taught and attended and adds his own experiences, resulting in a highly informative, interactive and entertaining set of courses that truly revolutionizes the way projects are run at his customer’s companies.
In addition to training, Bruce sets up PMOs at organizations, supervises the writing of a Project Management Guidebook, facilitates Portfolio Prioritization sessions and increases the organization’s Project Management Maturity .
He is located on LinkedIn.
Contact Bruce directly atBruce@RoundTablePM.com
David Gorky – has over 30 years of experience in medical device and combination product development, project management, strategic planning, quality, business development, licensing, and acquisitions.
David is a Senior Regulatory Advisor where clients regularly leverage his expertise on projects involving products regulated by the U.S. Food and Drug Administration (“FDA”). David’s experience includes auditing, risk management, design control, product development, manufacturing operations, and compliance and remediation with FDA QSR, ISO 13485, and ISO 14971. David has developed dozens of medical devices for global markets in areas such as implantables, disposables, diagnostics, drug/device combinations, and drug delivery systems. He has created and implemented quality systems meeting both U.S. and EU standards, has experience auditing and leading quality system remediation projects, and has provided strategic and tactical support during several Class II recalls. He David also has experience with FDA Class I, II, and III devices following the 510(k) and PMA processes, as well as European and Japanese regulatory filings. David has provided support to Fortune 100 companies, multinational companies, and start-ups. He has supported projects and teams globally.
David held positions of increasing responsibility during his career, including Vice President Product Development; Sr. Director, Global Critical Care Product Development; Director of Engineering; Manager, New Program Development; Manager, Project Management; and Principal Engineer.
John Tse – is a Program/Project Manager in a wide variety of information technology projects. Interested in helping companies to successfully plan and execute their information technology projects to meet time, cost and scope objectives.
– Project management training: course developement; on-site classroom instructor
Specialties: – Project Management Professional (PMP) certified
– Certified Object-Oriented Software Engineer
– Project management training
– Experienced in the following industries:
. Investment banking
. Corporate training