Blog

Patient Safety is the Perspective for Prevention

April 3, 2024 || Cheryl Bondurant
 
When I first started writing this blog, the subject was remediation for regulatory inspections. But, as I progressed through the authoring of this blog, I asked the question why should we focus on regulatory inspection remediation instead of prevention of inspection remediation? For those of you who have been involved…

Supply Chain Resilience

March 18, 2024 || Connie Leech
 
Most people take for granted that medication prescriptions will be ready at the pharmacy counter and available for pick up when ordered to get themselves on the road to recovery.  The COVID-19 pandemic exposed vulnerabilities and challenges in pharmaceutical supply chains, leading to drug shortages and disruptions. While some aspects…

Patients emerge as the ultimate beneficiaries of Aseptic Processing Technology advancements

March 18, 2024 || Connie Leech
 
Aseptic Processing Technology advancement innovations such as robotics, artificial intelligence, & rapid test methods have continued to ensure the production of safer, more effective medical products, thereby enhancing patient outcomes and overall satisfaction. Manufacturers can consistently deliver sterile medications and devices by employing state-of-the-art aseptic processing techniques, reducing the risk…

LESSONS LEARNED FROM IMPLEMENTING THE FDA’s CSA GUIDANCE: PART 2– EXECUTING

March 18, 2024 || Brian Stephens
 
This is the second in a series of three articles that present lessons that our validation team learned while completing a pair of validation projects that used the FDA’s draft of the Computer Software Assurance for Production and Quality System Software Guidance (CSA). The number of resources, the amount of…

Transformative Power of Virtual Twins (Part 3 of 3)

March 18, 2024 || Kevin Hawkins
 
This is the final installment of a three-part series exploring the transformative power of Virtual Twins as part of 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…

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…