Episode 25 – The Parenteral Drug Association & Evolution of Drug Development with Michael Carroll скачать в хорошем качестве

Episode 25 – The Parenteral Drug Association & Evolution of Drug Development with Michael Carroll

🎙️ Full audio, including show notes & full transcription: https://dsinpharmatics.com/ep25 🍏 Subscribe on Apple Podcasts: https://dsinpharmatics.com/apple 🎧 Subscribe on Spotify: https://dsinpharmatics.com/spotify 🎤 Subscribe on Google Podcasts: https://dsinpharmatics.com/google ▶️ Twitter:   / dsinpharmatics   ▶️ LinkedIn:   / 238776   ▶️ Instagram:   / dsinpharmatics   ————————— SUMMARY: ————————— Michael Carrol 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. ————————— TAKEAWAYS: ————————— 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 ————————— 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.