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Mitigating Compliance Risk from Third Party Intermediaries

UL EduNeering

Compliance officers need steady nerves to manage the legal and compliance risks posed by third party intermediaries. One compliance professional, at a large branded company, put it perfectly, "It's like shoveling dry sand. You vet a company, audit its compliance program, make sure its employees or subs are trained - and within a year, half its workforce has changed. Now, you're carrying the risk for a different company with a lot of new employees or subcontractors. Who are the new people? What do they do and what do they know? Are they trained? Are they compliant? They aren't your employees but as far as compliance risk is concerned, there's no difference between a twice-removed agent and a 20-year employee in the office next to you. Noncompliance is noncompliance. What your intermediary does belongs to you, period."

Tags : fda, gmp, gcp, gxp, cms, osha, qsr, 21 cfr part 11, regulatory compliance, pharmaceuticals, medical device, good manufacturing practices, quality system regulation, online compliance training, part 11 compliance, fda part 11 compliance, iso 13485, quality management system, life science, health care


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Published:  Jul 05, 2012
Length:  8
Type:  White Paper