Tags » FDA Regulations

High Qualities of Effective Recruiters

In today’s time, recruiting a high-quality candidate, who meet business demands, is a tough job for the recruiter. The main problem of recruiters is their inadequacy to on-board the candidate, the hiring manager wanted. 761 more words


FDA's New Inspection Policy and Strategic Regulatory Updates 2018

FDA requires that all computer systems that handle data regulated by the Agency to be validated in accordance with their guidance on computerized systems. In 1997, 21 CFR Part 11 was issued to address electronic records and signatures, as many laboratories and other FDA-regulated organizations began seeking ways to move into a paperless environment. 359 more words


Which can leave the work of meeting regulatory requirements to FDA Services

FDA consulting services are those services that are offered by independent, mostly private companies in helping to meet FDA requirements. FDA consulting services are offered to organizations that have to meet FDA regulatory requirements. 320 more words


Principles of FDA requirements for medical devices

The FDA has some clear-cut requirements that those manufacturing medical devices have to meet in order to get their products approved. FDA requirements for medical devices cover regulations for these devices, based on the way they are classified, and for meeting set regulatory guidelines. 505 more words


What is a quality assurance unit?

Suppose you were just hired in a Quality role (QA specialist, tester, auditor, inspector, reviewer, technical data specialist, etc.). During your orientation and training people bandy about such acronyms and initialisms as the GLPs, the OECD, the QAU, and 21 CFR 58. 1,105 more words

Big Government Strikes Again

Thanks to crushing new FDA regulations on the cigar industry, one generations-old factory may be forced to shut its doors for good. The owners of Tabanero Cigars in Tampa, Florida say they’re already feeling the pinch. 47 more words

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