Successful Project Management for Software Development and Validation
10:30 AM – 11:30 AM |
Software projects, be it for automation or data management, can not be effectively managed as traditional projects. This presentation will discuss 21st century deliverables, processes and tools necessary for software project success:
selection and implementation of the development and testing strategy
acquisition of commitment and translation to project planning
project process measures of effectiveness
development of simplified tools for reporting, management, and traceability
subcontractor management and contractual deliverables
management of issues, problems, and changes
ongoing software maintenance and life cycle support
Concepts are applicable to software development projects for both automated medical devices themselves and the automated or data-driven processes that manufacture them.
Speaker: John Hannon | Global Business Lead, Automation and IT Services, CAI
John Hannon is an Executive Consultant and Business Area Leader for Automation and IT at Commissioning Agents. With over 29 years in the pharmaceutical, IT, and process automation fields, he has been instrumental in starting up cutting-edge biotech facilities for companies such as Baxter, Monsanto, Amgen, Genentech, Pfizer, and Cook.
He has managed multi-million dollar projects and project teams across the US and Europe, and is responsible for delivering hundreds of high-profile, mission-critical projects for biotech, pharmaceutical, and medical device customers. Currently he leads CAI’s IT and Automation business area – responsible for the development of automation, MES, and other IT system projects within the international client base.
With a demonstrated knowledge of quality assurance and regulatory compliance across the pharmaceutical industry, Mr. Hannon has led national and international seminars with ISPE, contributed to several publications such as Pharmaceutical Technology, and has led speaking venues related to risk-based approaches to smarter integrated system delivery compliant to the FDA, USDA, and EU regulatory agencies. He is an active and sought-after consultant for complex IT and automation problems in the pharmaceutical industry.
Mr. Hannon holds a Bachelor of Science in Electrical Engineering from Georgia Tech, has completed studies at Harvard Business School, is a Certified Pharmaceutical Industry Professional and holds Professional Engineering certification in the state of North Carolina. Most recently he has worked with pharmacetical clients to resolve data integrity related regulatory citings.