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Validation
& Compliance Institute Provides Regulatory Training for SIMCO
Electronics
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.VCI 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.
VCI 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.
Dietary Supplement Regulations: What You Need to Know In 2007 the Food and Drug Administration has published new Current Good Manufacturing Practices (CGMPs) regulations for dietary supplements. These regulations affect any manufacturers of dietary supplements who sell product in the United States.
Evolution of Validation In November 2008, the U.S. Food and Drug Administration (FDA) published draft guidance on process validation. Entitled Process Validation: General Principles and Practices, this draft guidance replaces the previous guidance issued in 1987.
FDA's New Process Validation Guidance Recommends Team ApproachThe November 2008 FDA draft guidance for process validation says "We recommend an integrated team approach to process validation that includes expertise from a variety of disciplines..." But when different people from different backgrounds work together, disagreements can stall your team. How do you get your project back on track?
Five Ways to Accelerate Root Cause Investigations Finding the root cause for errors and preventing them from happening again is always good business. Your quality improves every time you prevent an error. Costs go down. And in some industries, like pharmaceuticals or medical devices, it's more than good business. It's the law. So there are plenty of incentives to find the root causes for errors.
Food Recalls and Mislabeling: How to Avoid Mistakes Before Products Hit the Shelves Spring is often a time that allergy sufferers dread. But for those who are allergic to food ingredients, that dread can be a daily occurrence. Following ingestion of a food allergen, a person with food allergies can experience anaphylaxis, which can lead to constricted airways in the lungs; severe lowering of blood pressure and shock ("anaphylactic shock"); and suffocation by swelling of the throat.
How to Get Your Project Approved What do you do when you have a great idea? You know how to save your company a ton of money or you've thought of a way to really improve a product. The problem is that you know that you have a great idea, but no-one else does. And you can't convert this idea into reality by yourself. You need resources. You need money. You feel that you need permission. What do you do?
Labeling Errors Make Recalls Likely The Food and Drug Administration (FDA) regularly monitors labels for false claims and errors, often pulling whole lots of product for which it finds a problem. Case in point: a recent nationwide recall of Encore Tablets, a dietary supplement sold in health food stores, via the internet and by mail order nationwide and in Canada.
The Myth of the Generic SOP What do you do when your boss tells you to write an SOP? Run and hide? Tell her how long it will really take to write one that’s any good? If you choose the latter option, be prepared for this “helpful suggestion”: “Why don’t you just download a generic SOP from the internet?” You would have been better off taking the former option. Here’s why.
A New Paradigm to Address the High Cost of Vendor Qualification Any pharmaceutical or medical device plant is a very complex place. Unless an auditor plans to take up residence at the vendor they have no chance to understand the true nature of these operations. The assumption today is that a BETTER audit means a LONGER audit. There has to be another way. What's needed is a new paradigm for vendor qualification; a tool that can drill deeply into the vendor's operation at low cost; something that can provide a more lasting measure of the vendor's performance than simply an audit.
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.
Quality by Design Streamlines Pharmaceutical Manufacturing The pharmaceutical industry wastes more than $50 billion a year in manufacturing costs, this according to findings of a study on the interplay of pharmaceutical manufacturing and the Food and Drug Administration (FDA). The study, conducted jointly by Olin School of Business at Washington University and McDonough School of Business at Georgetown University, received no funding from either the pharmaceutical industry or the FDA.
Relief For Latex Allergy Sufferers As FDA Clears New Medical GloveMost allergies are easy to cope with by simply avoiding the trigger. Sometimes that’s easier said than done, such as in the case of a latex allergy. Estimates vary, but anywhere from 3 percent to 22 percent of all health care workers are sensitized to traditional latex.
Two Profound Facts about Employee Performance There should be a requirement that anyone who manages people should have also raised at least one child. I don't really mean that, but raising children certainly helped me understand adults. There are so many similarities. I first learned this when my daughter was very young.