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CO-LOCATED EVENTS

Speaker

Sachin Bhandari

Head of CSV, Boehringer Ingelheim International GmbH

I am Sachin Bhandari, a digitization enthusiast with 25 years of experience in Quality and IT within the pharmaceutical industry. I specialize in bridging the gap between Quality and IT, driving the creation of Digital Quality Systems for Enterprise, Labs, R&D, Manufacturing, and SCM.

My expertise lies in delivering complex projects such as paperless CSV frameworks, SAP HANA validation, and large-scale Change, Document, and LIMS Management. I have led multicultural teams globally, ensuring seamless project execution and integration. With a track record of zero audit findings, I have implemented solutions that significantly reduce risks, save millions, and set new standards in digital compliance. My leadership in digital transformation has been recognized industry-wide, saving over $80 million and redefining quality and audit readiness.

I am passionate about collaborating with forward-thinking professionals to drive digital excellence and regulatory compliance. Let's connect to explore synergies and advance pharma digitalization. This version is concise, pharma-focused, and highlights your key achievements and expertise.

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Session

How Can Computer System Validation (CSV) in MES Implementations Balance Compliance, Efficiency, and Innovation in the Pharmaceutical Industry?

(3) Challenge Your Peers

Monday, September 22

04:45 pm - 05:45 pm

Live in Berlin

Less Details

  • What are the most significant challenges in validating MES systems in compliance with regulatory standards such as FDA 21 CFR Part 11 and EU GMP Annex 11?
  • How can risk-based approaches streamline the CSV process while maintaining data integrity and reducing compliance burdens?
  • What best practices can be adopted to future-proof validated MES systems to accommodate upgrades, patches, or new features without jeopardizing compliance?
  • How can digital tools and automation enhance the CSV process to reduce time and effort while ensuring robust validation?
Workshop

Company

Boehringer Ingelheim International GmbH

Boehringer Ingelheim is working on breakthrough therapies that transform lives, today and for generations to come. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. More than 52,000 employees serve over 130 markets in the three business areas, Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing.
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Colocated with
Pharma Maintenance Europe 2025 is part of the Smart Manufacturing & Industry 4.0 Event Series. You can find more events here.
Date
September 22 – 23, 2025
Location
Maritim proArte Hotel
Friedrichstraße 151, Dorotheenstraße 65
10117 Berlin
Phone
+49 (0)30 52 10 70 3 0
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