Article Archives

FDA Cracks Down on Fake Cures

Licensed physicians prescribe drugs that undergo clinical testing to determine if they are safe and effective for their intended uses. These drugs have been clinically tested or reviewed by FDA for safety and effectiveness.

Of course, where there are rules and regulations, there will be those who try to take shortcuts.

Off-Label Use of Medical Devices

How can a medical practitioner decide whether a medical device that they want to use for one of their patients is legal and approved by the Food and Drug Administration? When a patient comes into a physician's office the patient is looking for the best, most modern care they can get. And a physician certainly wants the same thing.

How to Evaluate the Quality of a Dietary Supplement

So, you've found a Dietary Supplement that exactly fits your special need. The information on the supplier's website appears to be consistent with everything that you've read and heard, and now you're ready to buy.

But there are questions on your mind. "What is the quality of this product that I'm buying?" you ask. "Can I really trust this supplier?"

Validation & Compliance Institute Provides Regulatory Training for SIMCO Electronics

Dearborn MI 4.13.10. SIMCO Electronics has chosen Validation & Compliance Institute (VCI) to provide online training for its employees who provide instrument calibration to the biotech, pharma and medical devices industries. SIMCO wanted to transition from conventional training to interactive online training to assure current Good Manufacturing Practices (cGMP) are used by all their employees.

MichBio Members Now Save on Validation & Compliance Institute Services

Ann Arbor 3.24.10. MichBio, the statewide association for Michigan’s biosciences industry, announced that its members will now receive discounted services from Validation & Compliance Institute, an FDA compliance consulting firm based in Dearborn, Mich.

VCI's Good Manufacturing Practices Certification is in Great Demand.

Validation & Compliance Institute (VCI) fills a growing demand with its auditing and certification of Current Good Manufacturing Practices for the food industry. Food producers who pass VCI's rigorous audits earn the right to display VCI's "GMP Verified" seal. This is a confirmation to potential customers that the producer has met the highest quality standards.

Validation & Compliance Institute, LLC, to Provide Medical Device Regulatory Training for the University of Michigan's Medical Innovation Center

VCI is developing a series of training videos for the University of Michigan Medical Innovation Center (MIC). The videos will introduce University of Michigan researchers to the regulations that are required by the US Food and Drug Administration (FDA) in order to market medical devices.

Validation & Compliance Institute, LLC, to Provide Dietary Supplement GMP Training for NSF International

VCI will provide a series of Dietary Supplement Good Manufacturing Practices (GMPs) trainings for DBA Analytical (DBA), a division of NSF International. The seminar series enables companies to understand the new GMP regulations for dietary supplements, which the US Food and Drug Administration (FDA) published in 2007.

Alternatives for Container and Closure Systems Sterility Testing

While sterility testing can be cumbersome and time consuming, there are FDA-approved options regarding container and closure system integrity testing. In fact, the Food and Drug Administration (FDA) recently released a guidance document on container and closure system integrity testing in lieu of sterility testing as a component of the Stability Protocol for Sterile Products.

Drug Pedigrees: Your Supply Chain Needs Them. Are You Ready?

This article describes the challenges of drug counterfeiting and the consequences when companies fail to recognize the threat. It then outlines the technical solutions that are available, assesses the merits of those solutions, and shows which solution fits best in different situations. Read it here.