Remove 12 16 Risk-based-approach-driving-manufacturing-improvements
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Challenges & Opportunities in Emerging Digital Health Technologies

ISPE

Thu, 10/27/2022 - 16:20. Emerging digital health technologies (DHTs) may improve the quality of life for patients with chronic and debilitating diseases and provide novel health care solutions for patients with unmet medical needs. Challenges & Opportunities in Emerging Digital Health Technologies. Trudy Patterson. Ryan Hoshi.

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Challenges & Opportunities in Emerging Digital Health Technologies

ISPE

Thu, 10/27/2022 - 16:20. Emerging digital health technologies (DHTs) may improve the quality of life for patients with chronic and debilitating diseases and provide novel health care solutions for patients with unmet medical needs. Challenges & Opportunities in Emerging Digital Health Technologies. Trudy Patterson. Ryan Hoshi.

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Contamination Trends & Proposed Solutions

ISPE

This article proposes recommendations for industry and RAs to address the identified problems. However, few studies have analyzed contamination trends to enable a more effective risk-based approach to control contamination in the manufacture of medicinal products.

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Removing Regulatory Hurdles for Continuous Pharmaceutical Manufacturing

ISPE

This article discusses how US regulators addressed the regulatory hurdles related to CM to broaden its adoption through engagement, regulatory science, guidance, and international harmonization. Continuous reactions and processes are a fundamental concept taught to all undergraduate chemical engineers, often in their junior year.

FDA 52
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Pharmacists’ Biggest Secret (About Themselves)

The People's Pharmacy

Our medical system is based on a fast-food-like model of herding patients/customers. According to Robert Lustig in his book Metabolical: The Lure and the Lies of Processed Food, Nutrition, and Modern Medicine (New York: HarperCollins, 2021, p. It’s always a risk vs reward situation. 19), our medical system is 97.5

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Agile, Data-Driven Life Cycle Management for Continuous Manufacturing

ISPE

This article provides a review on the current state of CM implementation, offers insights into life cycle management and regulatory aspects, and explains how a data- and knowledge-centric approach to risk management can help CM achieve its full potential. It is recognized as a key process intensification approach.

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CMC Requirements for New Drug Registration in Latin America

ISPE

Positive improvements have been observed in the acceptance and implementation of international standards by various regulatory agencies in Latin America. Alternate approaches to meeting local requirements emerged during the COVID-19 pandemic: one example is the acceptance of electronically generated regulatory documents (e.g.,