Industry Regulations & Compliance Flashcards

Under HIPAA, how long must covered entities retain documentation of required workforce privacy training?

Answer: 6 years

45 CFR 164.530(j) requires retention of required HIPAA documentation for 6 years.

Under the U.S. Sentencing Guidelines for organizations, what training element is part of an effective compliance and ethics program?

Answer: Periodic, practical communication and training on standards and procedures for employees and leadership

USSG §8B2.1 calls for effective training programs and dissemination of compliance information throughout the organization.

ISO 9001:2015 clause 7.2 (Competence) requires organizations to do what regarding training?

Answer: Retain documented information as evidence of competence

Clause 7.2 requires determining competence, taking actions to acquire it, evaluating effectiveness, and retaining evidence.

In FDA-regulated pharmaceutical manufacturing, 21 CFR 211.25 requires personnel training in what?

Answer: Current good manufacturing practice (CGMP) and their particular job functions

21 CFR 211.25 requires training in CGMP and specific job operations, conducted by qualified individuals on a continuing basis.

An LMS stores e-signatures for FDA-regulated training records. Which regulation governs electronic records and signatures?

Answer: 21 CFR Part 11

21 CFR Part 11 sets FDA requirements for trustworthy electronic records and electronic signatures.

DOT hazmat regulations (49 CFR 172.704) require hazmat employees to receive recurrent training at least how often?

Answer: Every 3 years

Hazmat employees must receive recurrent training at least once every three years.

A training developer wants to use a copyrighted video clip in a corporate course. Which factor is NOT one of the four statutory fair use factors?

Answer: Whether the user credits the author

Attribution is not a fair use factor; the four factors are purpose, nature, amount used, and market effect.