Paul Long is a Project Management Consultant at Design Space InPharmatics. Paul has supervised government regulatory pharmaceutical industries for over twenty years and has a wealth of business knowledge. He knows how to build and lead high-performing, cross-functional teams, how to prioritize and the importance of meeting budgets and targets. In this episode, Paul, Ed, Meranda and Brian discuss the benefits and challenges of virtual project management during the COVID-19 pandemic, integral project management tools and how project management fits into drug development and the overall CMC space.
Run time: 43:53mins
Episode 19 - Complexity of Project Management in Drug Development with Paul Long
Video Credit: DSI, a PLG Company
Takeaways:
00:55 – Ed, Brian and Meranda welcome to the show Paul Long who shares his well-rounded background as a project management consultant and speaks to some of the benefits and challenges of virtual project management
17:09 – How Paul manages working with clients virtually
19:08 – Tools Paul integrates in his project management process
21:17 – Paul provides examples of how project management fits into drug development
24:52 – Paul shares some project management tools that he utilizes, including the Gantt Chart
29:35 – Paul makes a final case as to why project management is important
33:41 – Paul differentiates between a project coordinator and a project manager
34:28 – Ed, Brian and Meranda thank Paul for joining the show
About CMC Live
FDA CMC regulations and guidance simplified through examination, real life experiences and risk-based advice. This podcast hopes to educate sponsors and individuals on agency related regulatory CMC matters. We will focus on the critical CMC issues and build programs that enhance drug development. CMC topics will include Regulatory Starting Materials, API and Drug Product Process, Formulation Development, Supply Chains, Analytical Controls. Advocating and interpreting CMC Strategy, directing CMC Operations and Quality Assurance oversight in conjunction with developing CMC submission content that represents the best interests of emerging biotech. NOT INTENDED TO BE PRESCRIPTIVE ADVICE BUT RATHER INTERPRETATION THAT IS RIGHT FOR YOU. Since 2007 we have provided our partners with innovative strategies and exceptional advice intended to enhance program development, product approval, and marketing presence.