GMP

QSR and ISO 13485 Harmonization: Enforcement, the Ultimate Question

QSR and ISO 13485 Harmonization: Enforcement, the Ultimate Question

A couple of weeks ago I had the pleasure of moderating one of the Food and Drug Law Institute’s (FDLI) Law over Lunch Sessions. I spent my lunch hour with industry folks and lawyers discussing the forthcoming Quality System Regulation and ISO 13485 Harmonization. One topic emerged as the front-runner of what was on everyone’s mind: how is the FDA actually going to conduct enforcement for this? Can we expect to see a major change in FDA enforcement?

Incorporating GDP through Lean Six Sigma

Incorporating GDP through Lean Six Sigma

GDP – far-reaching within all GxP-compliant organizations, and yet it can be a challenging point for many during audits. GDP, or Good Documentation Practices, are essential to maintaining an effective QMS. In a previous blog post, we touched on GDP, ALCOA+, and recommendations for successful GDP practices. In this post, we’re going to take a deeper dive into GDP, the governing regulations, and tips on consistently maintaining GDP.

Software as a Medical Device

Software as a Medical Device

Software-related medical devices are taking over the medical device industry. There are three types of software-related medical devices in the industry software as medical devices, the software is integral to medical devices, and software used in the manufacturer or maintenance of a medical device1. Software that is….

Decorative Contact Lenses

Decorative Contact Lenses

Decorative contact lenses are a known medical device and are treated with the same standards as corrective contact lenses. Decorative lenses are also known as

Water for Pharmaceutical Use

Water for Pharmaceutical Use

When determining which type of water system is needed for pharmaceutical manufacturing it is important to keep in mind how the water will be applied to the product.

Investigational Device Exemption

Investigational Device Exemption

An investigational device exemption (IDE) allows for investigational devices to be used in clinical studies to collect the proper safety and effectiveness data….

Concepts of Modern Quality systems

Concepts of Modern Quality systems

A quality system’s main purpose is to consistently produce safe and effective goods while also guaranteeing that these actions are sustainable long term. It should be emphasized that putting in place an effective quality system in a manufacturing company will take a substantial amount of time and effort. By incorporating effective knowledge-building methods into day-to-day operations, a strong quality system will improve…

Innovations in Gendered Heart Disease Research

Innovations in Gendered Heart Disease Research

Heart disease is the leading cause of death in the United States equally impacting all. Being Women’s Health Week, we want to highlight the impact heart disease has on the livelihood of women and what new developments there are in the life sciences innovation world that would reduce the impact it has on society.

Why Perform a Gap Analysis?

Why Perform a Gap Analysis?

‌  As new technologies continuously push the limits of medical devices and drugs, regulations and governing...

FDA Approves Comirnaty

FDA Approves Comirnaty

‌  The day has come where the U.S. Food and Drug Administration finally approves the first COVID-19 vaccination for...

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