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Navigating the Maze of Who Regulates Healthcare Compliance

MedTrainer

Food and Drug Administration (FDA): The FDA regulates compliance in pharmaceuticals, medical devices, and biotechnology products. Drug Enforcement Administration (DEA): The DEA enforces compliance related to controlled substances, ensuring they are used for legitimate medical purposes and not diverted for illegal use.

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The History of Healthcare Compliance

MedTrainer

Key Changes in the History of Healthcare Compliance The face of healthcare compliance has changed dramatically in the last 100-plus years: Inception (Early 20th Century): Healthcare compliance began as a response to concerns about the quality of healthcare provided by medical practitioners.

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What Is a Credentialing Specialist?

MedTrainer

First , a credentialing specialist reviews and verifies the educational background, licenses, certifications, and work experience of a caregiver. This process involves contacting educational institutions, licensing boards, and previous employers to validate everything. Compliance Assessment. Database Management. Experience.

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Who Audits For Healthcare Compliance?

MedTrainer

A healthcare compliance audit is a systematic and objective evaluation of an organization’s adherence to various regulations, laws, internal policies, and procedures. Gathering Information: Collecting relevant documentation, policies, procedures, and other materials necessary for the audit.

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How to Choose the Right eQMS – The Ultimate Guide

Dot Compliance

Evaluate Compliance Needs: Assess the specific compliance requirements applicable to your organization. This may include regulations such as ISO 13485, GMP, GLP, cGMP, or industry-specific guidelines. Understanding your compliance needs ensures that the selected eQMS can meet the necessary regulatory standards.

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How to Choose the Right QMS – The Ultimate Guide

Dot Compliance

Evaluate Compliance Needs: Assess the specific compliance requirements applicable to your organization. This may include regulations such as ISO 13485, GMP, GLP, cGMP, or industry-specific guidelines. Understanding your compliance needs ensures that the selected QMS can meet the necessary regulatory standards.