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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?
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.
We Invest In Our Employees
At FDAQRC, we understand that the best business practices must start with our employees.
National Volunteer Month
During the month of April, FDAQRC encouraged employees to donate or volunteer. Read about the impact our team made!
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.
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.
Strategies for Combating Education Bias in Regulatory Workspaces
This downloadable poster elaborates on the problems surrounding education bias in the biopharmaceutical industry.
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 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!
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.
FDAQRC Experiments with a Four-Day Work Week
The new schedule was meet with an overwhelmingly positive response.
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.
The War For Talent Continues
With no end in sight, FDAQRCandidates was created to help both employers and employees in this super competitive market
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.
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.
The Growing Trend Of
Quality & Regulatory Affairs
Quality & Regulatory Affairs
The advantages of Outsourcing vs. Developing In-House Capabilities
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.
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
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.