Data Pedigree: The Foundation of Pharmaceutical Quality Control
Quality is a top priority during clinical trials, as poor data quality can jeopardize patient safety and result in costly
Mack Powers
Changing the Way, We Look at Pharmaceutical Operations With Analytics
With the advent of pharma 4.0 and the ever-growing adoption of Industry 4.0 principles, there is a big push to
Mack Powers
Quality and Compliance in the Food and Beverage Industry
The food and beverage industry is one of the most heavily regulated industries in the United States. There are a
Mack Powers
MEP Engineers: What They Do and Why You Might Need One
As buildings have become more complex and technologically advanced, the role of MEP engineers has become more important. With their
Mack Powers
Robotics in Pharmaceutical Manufacturing: Achieving FDA Compliance with Automation
It’s no secret that the pharmaceutical manufacturing industry is under intense scrutiny. The U.S. Food and Drug Administration (FDA) regulates
Mack Powers
Challenges of Facility Design and Construction for Biotechnology Companies
Biotechnology companies have specific needs when it comes to the design and construction of their facilities. They need laboratories that
Mack Powers
Data Integrity
Data is critical throughout the drug life cycle in pharmaceutical, biotech, and other healthcare facilities, especially during the clinical research,
Mack Powers
Facility Management: Pharma 4.0
Over the years, the pharmaceutical industry has undergone a huge transformation with production moving from small-batch manufacturing to mass production
Mack Powers
Data Integrity: FDA 483s and Warning Letter Trends
As the FDA continues to ramp up its data integrity enforcement efforts, companies in the pharma, biotech, and food manufacturing
Mack Powers
FDA GUIDANCE AND STANDARDS
In December 2018, the FDA issued draft guidance intended to help pharmaceutical companies comply with current good manufacturing practice (cGMP)
Mack Powers
Challenges with Laboratory Data Integrity and Compliance
Interview Transcript: Mack Powers (00:07):We’re here with Mitchell Wheeler today. Mitchell, it’s great to be talking to you. Mitchell is
Mack Powers
Maintaining Quality while reducing cycle times during the Clean in Place process
Interview Transcript: Mack Powers (00:07):So Tom, it’s good having you again today. You and I have been talking about CIP