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Transformative Power of Virtual Twins (Part 2 of 3)

March 18, 2024 || Kevin Hawkins
 
This is the second installment of a three-part series exploring the transformative power of Virtual Twins when applied to an asset induction effort for facility maintenance. Part One of this series provided an overview of implementation of this technology and benefits once completed. Now, in Part Two we will address…

Transformative Power of Virtual Twins (Part 1 of 3)

March 18, 2024 || Kevin Hawkins
 
This is the first installment of a three-part series exploring the transformative power of Virtual Twins when applied to an asset induction effort for facility maintenance. The information in this series is based on the use of Virtual Twin technology for a biomanufacturing site, but the same principles could be…

Five Keys to Successful Facilities Management

February 23, 2024 || Mark Burlingham
 
Facilities Management is a critical aspect of maintaining a safe and efficient workplace. It involves a wide range of tasks, from maintaining the physical infrastructure to managing resources and ensuring a comfortable environment for employees. Below are five key areas where organizations commonly have room to improve their Facilities Management…

LESSONS LEARNED FROM IMPLEMENTING THE FDA’s CSA GUIDANCE: PART 1 – PLANNING

February 12, 2024 || Brian Stephens
 
After several years of conversation with drug manufacturers and consultants about the state of computer system validation, the FDA issued a draft of the Computer Software Assurance guidance in September 2022. Since that time, I have used this guidance to reduce the effort and cost required to complete two large…

Remote Regulatory Assessments – Q&A: Here to Stay

February 9, 2024 || Emily Purchase
 
On January 26, 2024, the Food and Drug Administration (FDA) provided notification of a revised draft guidance on Remote Regulatory Assessments (RRAs).  The FDA has updated its guidance on remote regulatory assessments (RRAs), emphasizing that they differ from inspections and outlining new powers granted by a recent spending bill. The…

Implementing a Risk-based Approach to Calibration 

February 9, 2024 || Joe Leuser
 
How does your organization determine calibration test points, tolerances, and frequency? A simple rule of thumb to calibrate instruments at 10, 50, and 90% of full-scale range and use a tolerance of 1.5 or 2 times the manufacturers’ tolerance. Many companies standardize frequencies to calibrate all critical instruments every six…

FDA Quality Management Maturity Program

January 15, 2024 || Martina McDonagh
 
Drug shortages in the pharmaceutical industry is a significant concern that has far-reaching consequences for the industry, the regulators, the healthcare system, and ultimately the patients. These shortages can be for a variety of factors including manufacturing and quality issues. To this end the FDA embarked on the Quality Management…

The Readiness Stage of Technology Transfer 

January 15, 2024 || Robert Ossig
 
During a pharmaceutical technology transfer (TT) project, the Readiness Stage plays a pivotal role by establishing the groundwork for a successful transition. This phase involves meticulous planning, coordination, and execution of key activities across various functions, each contributing to the readiness of the Receiving Unit (RU) for Process Performance Qualification…

The Future of FDA Regulatory Inspections:   

December 27, 2023 || Connie Leech
 
The Office of Regulatory Affairs (ORA) at the U.S. Food and Drug Administration (FDA) is currently buzzing with activity and exciting developments. Here’s a snapshot of what happened in the last 24 months:  In June 2023, the FDA updated its new model for the Office of Regulatory Affairs (ORA). This…

Bridging the Gap: Role Clarity, Skill Investment, and the Battle Against Drug Shortages 

December 20, 2023 || Chris Spiak
 
As advancements in medical science continue to expand the array of available treatments, the demand for pharmaceuticals has surged.  This surge has caused an alarming increase in drug shortages.  Complex factors, including regulatory hurdles, supply chain disruptions, and unforeseen global events, have converged to create a landscape where the availability…