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Halloween Special – Ghosts, Spirits and CMC Regulatory, A Halloween Story

Halloween Special – Ghosts, Spirits and CMC Regulatory, A Halloween Story

FromCMC Live - Chemistry, Manufacturing & Controls


Halloween Special – Ghosts, Spirits and CMC Regulatory, A Halloween Story

FromCMC Live - Chemistry, Manufacturing & Controls

ratings:
Length:
50 minutes
Released:
Nov 6, 2020
Format:
Podcast episode

Description

What We Covered01:12 – Introducing a very spooky Halloween Special where Ed, Brian, Meranda and the rest of the DSI Team share stories of time spent in creepy labs and other scary situations21:58 – Paul tells a story of working the graveyard shift at a hospital25:06 – Valerie and Meranda share their own spooky experiences working in pharma35:01 – An Excel Horror Story36:06 – Ed shares a scary email story followed by Dave’s liquid ammonia experience48:55 – Ed, Brian and Meranda thank everyone for joining the show and sharing their storiesTweetable Quotes“I’ve never tasted cherries as delicious as the ones that were being fed and rooted from the formaldehyde and sulfuric acid that was being pumped into the soil.” “You know it’s a bad day when the local news crew is sitting in the lobby when you walk in.” “I would have to go down and walk – this is in the middle of the night, no one around – walk down to the basement, past the morgue, through the boiler room, into this dark, dank, dusty place with like rats and dig through boxes for the records.” “I’ve scared myself. I was working late one night and we had liquid oxygen on site and every once in a while you’d get a hiss or a clank or something weird. And the warehouse was making an awful lot of noise one night so I was like, ‘Ok, I’m just gonna go home.’” “In the days before corporations had things like change control, and quality groups on site and so forth, Smith-Kline and others were organized as just a bunch of chemical operators. And that was it. There was no other functions on site.”“Dave told a story about liquid ammonia and some scary situation there.” “I’ve actually been at a place where we did heavy duty analysis on bungie cords.” Relevant LinksDesign Space InPharmatics – LinkedInDesign Space InPharmatics – TwitterEdward Narke on LinkedIn
Released:
Nov 6, 2020
Format:
Podcast episode

Titles in the series (27)

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.