CTM Industry Regulations & Compliance 4

Question 1

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

Accepted Answer

6 years

Answer

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

Question 2

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

Accepted Answer

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

Answer

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

Question 3

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

Accepted Answer

Retain documented information as evidence of competence

Answer

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

Question 4

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

Accepted Answer

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

Answer

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

Question 5

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

Accepted Answer

21 CFR Part 11

Answer

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

CTM - Certified Training Manager Practice Test