• 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  

“The PDA was kind of the bridge. It’s the Parenteral Drug Association – its focus is sterile injectable product. But it’s into all kinds of different things.” 

“The biggest things that are most frequently used in my case are the media fill, as Brian mentioned, and environmental monitoring.” 

“When you cite regulations from Europe, it used to be you would pull the British because they were gonna be the standard. If you could pass Brit, you could worry about anybody else at all; you were fine.”

“It’s an entire system that you’re trying to get where every little thing that fits into the process has been qualified and can be depended on. From the raw materials coming in the door to the viles, to the stoppers, to the machinery, the environment, the filters, the air quality and differentials – all of that stuff fitting together.” 

“With drug development, you’re not having a life depend on you. You’re having tens of thousands of lives depend on you.”

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