Michael Carroll is Senior Consultant of Microbiology and Aseptic Manufacturing at Design Space InPharmatics. He is an accredited Microbiologist with over 35 years of product development, quality control and GMP manufacturing experience in the pharmaceutical, biotechnology and medical device industries.
In this episode, Ed, Meranda, Brian and Mike discuss the Parenteral Drug Association, the role of regulatory approvals and other stories from Mike’s illustrious career. They talk about the ever-evolving nature of CMC and the pressures of working in drug development and manufacturing.
What We Covered
- 00:55 – Ed, Meranda and Brian welcome today’s guest, Mike Carroll, who speaks to his background in microbiology and product development
- 04:28 – Mike talks about his involvement in the Parenteral Drug Association (PDA)
- 07:51 – Lessons Mike has learned throughout his career and expounds on the relevance of PDA technical reports
- 15:03 – The evolution of regulatory approvals in the pharmaceutical industry
- 17:34 – Mike describes the influence of the PDA today, given the pandemic
- 20:18 – Mike explains a typical day working in microbiology and quality control and assurance
- 23:11 – The pressure of working in pharmaceutical drug development and final comments from Mike
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