With scrutiny from the FDA increasing, we are providing clients with something they have never had before.
Malvern, PA (PRWEB) November 03, 2016
The Center for Professional Innovation and Education (CfPIE), the global leader of technical training across the life sciences industry, has introduced a new certification program to address revised Good Laboratory Practices (GLP) regulations that the FDA published in August 2016.
The FDA is currently conducting surveillance inspections of laboratories, testing sites, and contract research organizations (CROs) to ensure that facilities comply with GLP and can maintain data integrity for their studies. If the Study Director cannot prove GLP compliance and data integrity, they can be subject to a Form 483, other Warning Letters, and more.
Until now, pharmaceutical, biotechnology, or medical-device laboratories and CROs in the United States had no way to show that their facilities are compliant with GLP, as their European counterparts can.
CfPIE’s unique GLP Facility Certification Program follows a 5-step auditing process and provides clients with the documentation they need to prove that their facilities and quality systems are fully GLP compliant.
“Our clients and students have frequently expressed a strong concern that there are no government bodies or independent agencies offering such a service," says Kenneth Cleaver, Ph.D., Director of CfPIE’s GLP Facility Certification Program. “With scrutiny from the FDA increasing, we are providing clients with something they have never had before.”
Learn more about the GLP Facility Certification Program.
The Center for Professional Innovation and Education (CfPIE) is the global leader in quality training for pharma/biotech, medical device, and skin/cosmetics segments of the Life Sciences industry. Classroom and custom on-site formats, and certification programs help improve personal skills, maintain regulatory compliance, and advance careers. Small class sizes and industry-active course directors promote a dynamic learning environment with excellent student-to-teacher interaction.