Patients emerge as the ultimate beneficiaries of Aseptic Processing Technology advancements
Aseptic Processing Technology advancement innovations such as robotics, artificial intelligence, & rapid test methods have continued to ensure the production of safer, more effective medical...
Read More
LESSONS LEARNED FROM IMPLEMENTING THE FDA’s CSA GUIDANCE: PART 2– EXECUTING
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...
Read More
Transformative Power of Virtual Twins (Part 3 of 3)
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...
Read More
Transformative Power of Virtual Twins (Part 2 of 3)
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...
Read More
Transformative Power of Virtual Twins (Part 1 of 3)
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...
Read More
Five Keys to Successful Facilities Management
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...
Read More
LESSONS LEARNED FROM IMPLEMENTING THE FDA’s CSA GUIDANCE: PART 1 – PLANNING
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...
Read More
Remote Regulatory Assessments – Q&A: Here to Stay
On January 26, 2024, the Food and Drug Administration (FDA) provided notification of a revised draft guidance on Remote Regulatory Assessments (RRAs).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...
Read More
Implementing a Risk-based Approach to Calibration
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...
Read More
FDA Quality Management Maturity Program
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...
Read More