Anelis Aurand-Araos

Anelis is the Director of Scientific Affairs and Chief Compliance Officer at WellSpring, and has over ten years of pharmaceutical industry experience in Regulatory Affairs, Quality, and Scientific roles. At the University of Florida, Anelis earned her Bachelor of Science in Chemistry, as well as Master of Science in Pharmaceutical Outcomes and Drug Regulatory Affairs. She also earned a Master of Science in Analytical Chemistry at Southern Connecticut State University. In her role at WellSpring Pharmaceutical, Anelis is responsible for the overall corporate quality, compliance, scientific & regulatory affairs direction and strategic guidance for the US and Canadian businesses.
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Recent Posts

Implementing a Change Control Process - Part 2

Posted by Anelis Aurand-Araos

At WellSpring, as with any other pharmaceutical manufacturing company, we developed a change control policy to ensure that any proposed changes to product or processes were thoroughly examined before they were implemented, and that no unintended consequences would result. As we are currently reviewing and updating our policy, we felt that sharing our methodology would be illustrative of our process and instructive to others who need better processes. 

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Topics: Change control process, change management, change control committee, QA

Implementing a Change Control Process - Part 1

Posted by Anelis Aurand-Araos

Change control is a systematic approach used in many industries to manage all changes made to a product or process. This is particularly important in the pharmaceutical industry, specifically as it applies to pharmaceutical manufacturing where the complexity of the tasks to be performed during manufacturing, packaging and analytical release testing require detailed documentation of each task. Any changes in how those tasks are performed or managed need to be illustrated and justified through a change control. In Part 1 of a two-part blog, we’ll look at the change control process in general, discuss some of the basic principles and review some of the changes in pharmaceutical development and manufacturing that require following a change control process. In Part 2, we will discuss the steps to implement such a process.

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Topics: Change control process, change management, Quality Unit (QU), RACI

Creating a Culture of “Quality Beyond Compliance”

Posted by Anelis Aurand-Araos

If your job is to develop and produce medicines to prevent disease and mitigate suffering around the world, quality is the guiding principle of your business model.

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Topics: quality, Corporate Culture

How Do You Set Up A Quality Organization?

Posted by Anelis Aurand-Araos

In order to set up a quality organization, the organization must have a culture of quality. Survey findings in the Forbes Insights-ASQ white paper published in fall of 2014 offer research findings which help illuminate what quality culture means to organizations globally.

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Topics: Quality & Regulatory

What Is The Best Way To Keep Up With Changes In FDA Standards?

Posted by Anelis Aurand-Araos

This is an interesting concept, one that actually goes by the name of “Regulatory Intelligence.”  Regulatory Intelligence (RI) is something that's really important because the standards are always evolving. In the United States, for example, they start at the top with the Federal Food Drug & Cosmetic Act, and recently, the Drug Quality and Security Act of 2013. FDA takes these laws and promulgates regulations and guidance documents to interpret those regulations.

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Topics: Quality & Regulatory