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 MoreTransformative 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 MoreTransformative 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 MoreTransformative 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 MoreFive 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 MoreLESSONS 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 MoreRemote 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On January 26, 2024, the Food and Drug Administration (FDA) provided notification of a revised draft guidance on Remote Regulatory Assessments (RRAs).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 MoreThe Future of FDA Regulatory Inspections:
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...
Read MoreBridging the Gap: Role Clarity, Skill Investment, and the Battle Against Drug Shortages
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...
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