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26
Mar
COVID-19: 5 Steps To Achieve Situational Awareness In The Pharma Supply Chain

To address the current worldwide COVID-19 pandemic, more controls are being imposed by cities, states, and countries. Trucks are being delayed at borders. Flights are being canceled. It is important to be capable of adapting work practices around this ever-changing situation.

Posted in: Manufacturing,
Tags: hazards, inventory, inventory management, resources, supply chain,
23
Mar
How To Stop Fighting Quality Fires Using Quality Risk Management

Do you like fighting quality fires? Do you enjoy generating meaningless metric reports that no one acts upon? Do you get the most from your quality risk management (QRM) program? This article provides three practical steps for integrating QRM into your quality system to ensure your organization stays on course.

Posted in: Manufacturing,
Tags: CCP, critical control points, QRM, risk management,
20
Mar
How To Facilitate Great Virtual Meetings During A Pandemic (Or Any Other Time)

Even before the global pandemic of the novel coronavirus, virtual meetings were on the rise, but now there is a public health imperative, with a large percentage of people working from home. If you are facilitating a risk assessment, a root cause investigation, or something similar, you may need to do a “virtual facilitation” with team members and subject matter experts who are scattered around the world.

Posted in: Manufacturing,
Tags: virtual meetings, work from home,
13
Mar
Understanding 2019 FDA Enforcement Trends — And What They Mean For 2020

The FDA conducted a total of 18,034 inspections in FY2019, off which 6,434 were inspections of biologics, medical device, or drug companies. Those inspections resulted in the issuance of 15,015 warning letters, a slight increase over 2018. The FDA also increased its import alerts, publishing 98 in 2019. This corresponded with a decrease in injunctions and seizures, showing the FDA’s preference for earlier preventive measures over later involvement.

Posted in: FDA, Manufacturing,
Tags: FDA, form 483, inspections, warning letters,
12
Mar
Clinical Operations In The Age Of A Pandemic

The Beat AML (BAML) Master Clinical Trial was focused on efficiency and speed of operations, not on the coronavirus outbreak or pandemics in general. Yet, the model and technologies used by BAML are applicable for biopharma sponsors who want to adapt their clinical operations to support remote monitoring and faster acquisition of data, while preparing for another outbreak or weathering the current crisis.

Posted in: Clinical,
Tags: coronavirus, logs, pandemic, records,
11
Mar
The 4 Stages Of Drug Delivery Device Evolution: An Inhaler Case Study

To illustrate how delivery device development is evolving in practice, we will use the example of respiratory inhalers. This is a well-established treatment modality, with mature technology solutions available, but one where you can envisage a number of future changes enabled by technology.

Posted in: Manufacturing,
Tags: drug device delivery, patient data, user behavior,