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Pharmacovigilance: Insights, Challenges, and Future Horizons

Navigating drug safety with a focus on insights, challenges, and digital innovations for a safer future.
Employees celebrating

The Future Looks Bright

Unveiling a year of achievements, growth, and industry connections - FDAQRC sets the stage for a thriving future in 2024.
Aggie 100

FDAQRC Named a 2024 Aggie 100 Honoree

FDAQRC is among the top 100 companies globally selected for the 19th annual Aggie 100 which honors the fastest-growing companies owned or led by Texas A&M Alum.

Celebrating 14 Years of Excellence

FDAQRC recaps a year of achievements as we celebrate 14 years in business as of October 2023!

Mastering the Difference: Monitoring and Auditing

Pharmaceutical research sponsors must make sure they follow both Monitoring and Auditing rules during their studies - so what's the difference?
Reviewing notes

Understanding the Distinctions: QA vs. QC

While these terms are sometimes used interchangeably, it is important to understand their distinctions and the specific protocols associated with each area.
Man Working with Cute Dog

We Invest In Our Employees

At FDAQRC, we understand that the best business practices must start with our employees.
Team Volunteering

National Volunteer Month

During the month of April, FDAQRC encouraged employees to donate or volunteer. Read about the impact our team made!
Women Educating Her Team

Applying Lean Methodology Practically

Lean Methodology is a way of optimizing the people, resources, effort, and energy of your organization toward creating value for the customer.
Auditor Writing Notes

How to Generate Consistent Work as A Consultant

Generating consisting work seems to be a common struggle our network is seeing. Here are a few tips to set yourself up for success as a consultant and increase your number of projects.
Learning Seminar - Furthering Education

Strategies for Combating Education Bias in Regulatory Workspaces

This downloadable poster elaborates on the problems surrounding education bias in the biopharmaceutical industry.
Home Office

Explore the Pathway to Consultancy

This downloadable poster presents the clear steps of how to become a consultant while evaluating if consultancy is the best fit for someone’s experience and career goals.
Importance of Monitoring Your Health

Importance of Equity in Healthcare

In honor of Black History Month we explore the need for equity in healthcare. The foundational goal is to ensure that everyone has fair access to healthcare and the right to be the healthiest version of themselves.

Transitioning From The FDA To Industry

Transitioning from the FDA into the industry can be an overwhelming experience. Here are some tips to keep in mind when entering a new role outside of the FDA.

Remediation & Continuous Improvement

Jim Darnell, Director of Remediation, presents the importance of Remediation & the Continuous Improvement process.

Happy Founder's Day, FDAQRC!

On October 12, 2022, FDAQRC will be celebrating 13 years of business. We thank our internal team, our clients, and our consultants, for our continued success!

F2F 2022: Folly Beach, South Carolina

Each year the FDAQRC team meets up for a Face-2-Face meeting. This year, our team meet up in Folly Beach, SC to look back, reflect, and plan for the future!
Man Reviewing Notes

Avoid Common Mistakes When Submitting Your Expenses in BigTime

At FDAQRC, our consultants are a vital part of our business model. We pride ourselves on ensuring our consultants have the tools they need to succeed.
Flex Day - Working by the Beach

FDAQRC Experiments with a Four-Day Work Week

The new schedule was meet with an overwhelmingly positive response.
GMP Auditor

Taking Preventative Action on Regulatory Compliance Processes

FDAQRC can identify trouble areas in your compliance processes and design a plan to correct it - leaving you prepared and confident for an FDA inspection.
Group Interviewing

The War For Talent Continues

With no end in sight, FDAQRCandidates was created to help both employers and employees in this super competitive market
taking notes

A Road Map To Improve Quality Culture

First presented at SQA 2022 FDAQRC’s Project Manager, Amanda White examines how poor-quality culture can take a toll on your organization.
GCP Lab

No Regrets with Vendor Qualifications

What's required, how to begin, and how to maintain vendor qualifications.

For Cause or Not For Cause

The best way to ensure that your firm is inspection ready at all times is to be proactive in preventing “for-cause” inspections and make the reactive approach the “not to be."

A Day in the Life of a FDAQRC Auditor

From a flexible work schedule to health insurance, FDAQRC values each and every employee, but the one we’re most proud of is the fact we allow our Auditors to do what they do best, audit.
Women working

Quantifying the Quality Professional’s Experience

Try not to rely on the quantity of audits an auditor has performed, it goes against the concept of quality over quantity.
Consultant consulting

Finding
the Right
Consultant

The questions you should be asking to find the right consultant.
Consultant consulting

Remote
Auditing

Discover the benefits of remote auditing.
Women putting on Covid-19 mask

Pharma/Med Device: 2020 Year in Review

In arguably the most challenging period in modern history, the pharmaceutical and medical device industries carried on in the face of disruption to personnel, supply chains, travel, and many more critical business areas due to the Covid-19 pandemic.

Running Your
Business as
a Consultant

Tips, tricks, and best practices to make the most of your business.

Is Your QMS Ready For ISO 13485:2016?

Review the five commonly asked questions from the industry regarding the transition to 13485:2016.