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Quality Creates...Perspective

General Quality, EHS, Risk Management

Risk-Based Regulatory Compliance for Manufacturing: A Practical 4-Step Approach

In 2015, the Code of Federal Regulations totaled nearly 180,000 pages of requirements. While not all of these will apply to any single manufacturer, regulatory compliance is still a major challenge for companies. In fact, many of them aren’t even aware of certain regulatory risks until it’s too late.

This fact is especially true when companies use manual or paper-based methods for quality or environmental management, which make it difficult to effectively track compliance activities.

With that in mind, today’s post looks at a practical, risk-based approach manufacturers can use to identify and assess compliance gaps.

Rachel Beavins Tracy
By Rachel Beavins Tracy
on Fri, Mar 23, 2018
   
Risk-Based Regulatory Compliance for Manufacturing: A Practical 4-Step Approach

In 2015, the Code of Federal Regulations totaled nearly 180,000 pages of requirements. While not all of these will apply to...

Rachel Beavins Tracy
By Rachel Beavins Tracy
on Fri, Mar 23, 2018
Comparing ISO 9001 & ISO 13485: The Difference Between the Two Standards

ISO 13485 for medical device quality management shares many similarities with ISO 9001, the leading global quality...

Rachel Beavins Tracy
By Rachel Beavins Tracy
on Mon, Mar 19, 2018
Using Technology to Support Behavior Based Safety Programs 

Look at leading organizations with low incidence rates, and you’ll notice one thing many of them have in common: behavior...

Rachel Beavins Tracy
By Rachel Beavins Tracy
on Fri, Mar 16, 2018
Reducing Overdue Corrective Actions: A Practical Guide

Imagine a situation where your plant has a huge backlog of corrective actions 30, 60, even 90 days overdue. Defects and...

Rachel Beavins Tracy
By Rachel Beavins Tracy
on Mon, Mar 12, 2018
Document Control for Food Safety: 7 Gaps to Watch Out For

Imagine the following situation: The U.S. Food and Drug Administration (FDA) is inspecting your facility, and regulators ask...

Rachel Beavins Tracy
By Rachel Beavins Tracy
on Fri, Mar 02, 2018
5 Questions for Your Corrective Action Plan

Danish physicist Niels Bohr once said, “Every great and deep difficulty bears in itself its own solution. It forces us to...

Rachel Beavins Tracy
By Rachel Beavins Tracy
on Mon, Feb 19, 2018
Avoid FDA Warning Letters with These 4 Document Control Best Practices

Incomplete records stuffed in the trash, with the signatures still showing. Blank forms issued complete with signatures....

Rachel Beavins Tracy
By Rachel Beavins Tracy
on Fri, Feb 16, 2018
How Different Industries Use Bowtie Risk Assessment

When it comes to making decisions informed by risk, each industry has its preferred risk assessment tools. A risk matrix is...

Rachel Beavins Tracy
By Rachel Beavins Tracy
on Fri, Feb 09, 2018
Employee Training Tips for a GMP Compliant Workforce

Is your employee training program proactive, looking forward and evolving to incorporate lessons learned? Or is it reactive,...

Rachel Beavins Tracy
By Rachel Beavins Tracy
on Tue, Feb 06, 2018

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