090 - Software Validation, Automation, No-Code Quality Tools and QMS with Harsh Thakkar

Combinate Podcast - Combining Drugs and Devices

English - June 21, 2023 10:00 - 44 minutes - 80.6 MB - ★★★★★ - 4 ratings
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Previous Episode: 089 - Talking HealthTech Podcast, Consistency, Australian Innovation in HealthTech, Content, and Community with Peter Birch

Next Episode: 091 - Combination Products Handbook Part 1: Foundation, Learning from the process, Case Studies and Book Q&A with Susan Neadle

On This Episode, I was joined by Harsh Thakkar, CEO of Qualtivate. Harsh walks through:

- Automating Quality with No Code Tools

- Software Validation

- Infrastructure Software

- Out of the Box

- Configured Software

- Custom Software Systems

Harsh Thakkar is the CEO and founder of Qualtivate, a data-driven quality management consulting firm for life sciences. He is an industry veteran who has spent more than a decade in quality assurance and regulatory compliance roles with companies like Takeda, Biogen, Merck, Johnson & Johnson, and Bristol Myers Squibb. He is an American Society of Quality (ASQ) Certified Quality Auditor and Certified Manager of Quality/Organizational Excellence.

Show References:

McKinsey article: https://www.mckinsey.com/industries/life-sciences/our-insights/smart-quality-reimagining-the-way-quality-works

FDA CSA guidance: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/computer-software-assurance-production-and-quality-system-software

Naval Ravikant's book: https://www.navalmanack.com/