Intricacies of obtaining a GMP license for a new facility ~ The QP Diaries with Chris Howell ~ Ep2

Intricacies of obtaining a GMP license for a new facility ~ The QP Diaries with Chris Howell ~ Ep2

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.

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