Monitoring storage and production environments typically require regulatory compliance and demands for safe and effective monitoring systems that protect a pharmacy’s livelihood and patient health. Regulatory bodies including the FDA, EMA, CDSCO, NMPA, MHRA, and ANVISA, as well as global institutions and associations like the WHO, ISPE, and PIC/S, emphasize the need for accurate measurement, data integrity, and secure recording of critical process parameters (CPP).
This requirement exists for pharmaceutical laboratories and manufacturing environments if data recording is electronic. Never, before have Life Science companies been able to collect and analyze such large amounts of data. Big Data is here for this industry, as is the ability to analyze that data. However, how can businesses work to increase assurances that the data collected is of the highest integrity possible? This is of even higher concern when data is collected from a regulated GMP process or environment.
Hear Our expert, “Hemen Pandya” discussing on how digitalization of environmental monitoring aids Life sciences regulatory compliance for sustainability and real efficiencies.
Key Takeaways:
- Knowledge about ISPE guidelines pertaining to Environmental Monitoring
- Implementation of Pharma 4.0 and its challenges with respect to regulatory compliance standards
- Addressing Cybersecurity within connected automation systems
- Optimization of energy adapting technology
Key Highlights:
- Facility management and Smart Factory technologies
- Latest Data Integrity requirements based on ALCOA (+) principles and risk analysis methodology
- Cybersecurity standards and best practices between IT/OT
Agenda of the Webinar:
Introduction: 2.30- 2.35 PM
Presentation: 2.35 – 3.20 PM
Q&A: 3.20 – 3.30 PM
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Hemen Pandya
General Manager, Life Science Business Development, Eurotherm
Having more than 3 decades of experience in competitive industries like Manufacturing Pharma, Life Science, and FMCG, Hemen Pandya heads as Business Development Manager for the Asia Pacific region at Watlow Eurotherm. Being a digital enthusiast, he has huge experience in Pharma Manufacturing automation solutions like Machine integration & upgradation, Industrial Internet of Things (IIOT), Manufacturing Execution Systems (MES), Enterprise Manufacturing Intelligence (EMI), Track and Trace connected enterprise and Information Solutions (IS) software/services. He now assists Eurotherm’s life science customers to provide automation solutions to their manufacturing challenges that enable regulatory compliance.
