Listen "Intricacies of obtaining a GMP license for a new facility ~ The QP Diaries with Chris Howell ~ Ep2"
Episode Synopsis
In this episode of the QP Diaries podcast, host Dal Pawar welcomes special guest Chris Howell to discuss the intricacies of obtaining a GMP license for a new build facility. They delve into the three important phases of leading a project of this nature. In addition, Chris shares valuable insights for aspiring QPs and how to balance risk when thinking about the end user.
Dal Pawar speaks with Chris, a seasoned quality assurance professional with over 30 years of experience. Chris shares his career journey and expertise as a QP in the pharmaceutical industry. Listeners will gain insights into the world of quality assurance and learn from Chris' words of wisdom.
If you're passionate about quality assurance and want to learn from industry experts, this episode is a must-listen.
Key moments
[00:02:43] QP training and qualification.
[00:06:23] Nuclear medicine and challenges.
[00:08:23] New site builds and approvals.
[00:12:09] Major challenges in licensing.
[00:17:29] Challenges in new builds.
[00:19:12] Going too early risks delays.
[00:23:07] Training nuclear medicine sites.
[00:26:29] Incorporating different cultures in operations.
[00:30:00] Building a strong leadership team.
[00:34:39] Sterility event and accountability.
[00:38:13] Balancing risk and patient care.
[00:43:03] Quality assurance in biotech.
Dal Pawar speaks with Chris, a seasoned quality assurance professional with over 30 years of experience. Chris shares his career journey and expertise as a QP in the pharmaceutical industry. Listeners will gain insights into the world of quality assurance and learn from Chris' words of wisdom.
If you're passionate about quality assurance and want to learn from industry experts, this episode is a must-listen.
Key moments
[00:02:43] QP training and qualification.
[00:06:23] Nuclear medicine and challenges.
[00:08:23] New site builds and approvals.
[00:12:09] Major challenges in licensing.
[00:17:29] Challenges in new builds.
[00:19:12] Going too early risks delays.
[00:23:07] Training nuclear medicine sites.
[00:26:29] Incorporating different cultures in operations.
[00:30:00] Building a strong leadership team.
[00:34:39] Sterility event and accountability.
[00:38:13] Balancing risk and patient care.
[00:43:03] Quality assurance in biotech.
More episodes of the podcast The QP Diaries, by AssureBio
From NHS QP to Innovation Leader – Adam Walker on Aseptic Transformation, AI & GMP Clarity
07/07/2025
Becoming a QP – Navigating Change, VIVA Prep & Real-World Insights with NSF Trainer Vicky
14/04/2025
Championing Quality, Leading with Purpose: Uche Ekwuozor on Diversity and Integrity in Pharma EP 13
02/04/2025
Bitesize Diary Entry - 11 [Mark King]
22/11/2024
ZARZA We are Zarza, the prestigious firm behind major projects in information technology.