{"podcast":{"title":"Let's Talk Quality","slug":"let-s-talk-quality-6567110","podcast_index_feed_id":6567110,"rss_url":"https://feeds.captivate.fm/lets-talk-quality/","website_url":"https://rx-group.io/","image_url":"https://artwork.captivate.fm/1ce986d0-acc5-4088-8268-af6f5dfbb463/eyGXJDmcc8NoXmM0aMUmvptV.png","author":"Hemish Ilangaratne","episode_count":83,"summary":"“Let’s Talk Quality” is a podcast that seeks to shine a light on quality assurance, a profession that acts as the cornerstone for bringing safer medicine to patients. For life science companies to continue to develop life-saving medicines, a culture of good quality must be driven across the industry, whether that be an early phase gene therapy biotech or a global pharma organisation. This podcast aims to drive that mission forward through inviting industry leaders, experts, and visionaries to share their knowledge, experiences, and strategies for achieving quality excellence. Join us on a journey of discovery as we unravel the importance of quality and its profound impact on businesses and society. Get ready to engage in insightful discussions, gain valuable perspectives, and unlock the secrets to fostering a culture of quality in every aspect of life. Tune in and let’s embark on this exciting quality-driven adventure together.","last_synced_at":"2026-09-29T16:18:46.595814+00:00","page_url":"https://stenobird.com/podcast/let-s-talk-quality-6567110"},"episode":{"title":"Geetu Abbi on When to Build a Digital Quality Function","slug":"geetu-abbi-on-when-to-build-a-digital-quality-function","published_at":"2026-09-22T11:45:00+00:00","page_url":"https://stenobird.com/podcast/let-s-talk-quality-6567110/geetu-abbi-on-when-to-build-a-digital-quality-function","show_page_url":"https://stenobird.com/podcast/let-s-talk-quality-6567110","url":"https://rx-group.io/captivate-podcast/geetu-abbi-on-when-to-build-a-digital-quality-function","audio_url":"https://episodes.captivate.fm/episode/4016a89c-df6d-43f8-9297-b4f0cfe67768.mp3","summary":"Geetu Abbi was handed the GAMP guide as a new validation engineer at Genzyme, and in 2024 she co-led one. Geetu Abbi on When to Build a Digital Quality Function In today's episode I was joined by Geetu Abbi, Head of Digital Quality Assurance at Alkermes. I wanted to speak to Geetu because Digital Quality was not a job title eight to ten years ago, and she has grown into the role from computer systems validation. She moved from software testing into validation at Siemens without a life sciences background, and in 2024 she co-led the GAMP guide for GCP and clinical trials. We talk about: - Moving from software testing into validation at Siemens, with no prior exposure to Part 11 or 21 CFR 820 - What Digital Quality is, and the gap it fills between site Quality and clinical Quality - Data lifecycle mapping, and why validation now has to be revisited with every change - Delivering seven validated systems in eight months to support the Alkermes-Mural Oncology separation in 2023 - Her advice to the next generation of Quality professionals on why they don't have to solve everything alone Thank you Geetu for sharing your journey. Timestamps: (00:00) Introduction and guest background (03:42) From QA to validation (08:00) Career turning point (13:04) What digital quality means (22:28) Digital quality as a career opportunity (29:58) How the team is structured (34:06) Advice for future quality leaders","meta_description":"Geetu Abbi was handed the GAMP guide as a new validation engineer at Genzyme, and in 2024 she co-led one. Geetu Abbi on When to Build a Digital Quality Fu…","key_points":[],"chapters":[],"topics":[],"duration_seconds":2472,"processing_state":"not_requested","actions":[{"name":"request_transcript","method":"POST","url":"https://stenobird.com/v1/public/podcasts/let-s-talk-quality-6567110/episodes/geetu-abbi-on-when-to-build-a-digital-quality-function/transcription-requests","description":"Idempotently request low-priority transcript generation for this episode."},{"name":"read_markdown","method":"GET","url":"https://stenobird.com/podcast/let-s-talk-quality-6567110/geetu-abbi-on-when-to-build-a-digital-quality-function.md","description":"Read the agent-friendly Markdown representation of this episode resource."}]}}