010 - "Don't Make Assumptions" with David Simoens

On this episode of the Combinate Podcast, we had David Simoens, COO at cGMP Consulting Group. David and I discuss his career, and dive deep into commissioning, qualification, and validation. David outlines the activities in including discussing URS, DQ, FAT/SAT, IQ, OQ and PQ. David outlines the a risk based approach for streamlining commissioning and qualification activities, highlights some important things to watch out for and also gives some great book recommendations!  David Simoens is a certified Project Management Professional with over 7 years of project management, engineering, and validation experience. David has a strong, professional background in aseptic fill/finish, lyophilization, cytotoxic and high potency, process development, radio-pharmaceuticals and enterprise quality management systems. Mr. Simoens assisted in C&Q standardization and implementation on a global level guided by ASTM E2500 and assisted in development of content for the ISPE Baseline Volume 5 guide. He led an effort to assess, pilot, implement and go-live with an electronic engineering platform for several global sites. David has designed, installed, and tested several commercial size Freeze-Dryers and Automated Loading Systems. He managed a month shutdown for one of the largest products on market. Currently, David is supporting NPI launches for a large pharmaceutical company and operating a 100 person consulting company across multiple clients. Founded in 2001, cGMP Consulting Inc. has strived to help our clients adopt new technologies and ensure that changes to your processes are compliant with current Good Manufacturing Practices (cGMP). Our experienced engineering and quality assurance consultants have helped many industry leading companies identify and remediate gaps, support international pharmaceutical manufacturing, and implement cGMP requirements.