April 15, 2014

The Six C’s of Complaints Management Best Practices for Life Sciences

Companies in the Pharmaceutical, Medical Device, and Biotech industries must meet many regulatory requirements… [more]

The Six C’s of Complaints Management Best Practices for Life Sciences The Six C's of Complaints Management Best Practices for Life Sciences

NERC and Industry Move in the Right Direction for Greater Reliability

There is a different feel out there in the NERC world, the Electric Reliability Organization (ERO) and… [more]

NERC and Industry Move in the Right Direction for Greater Reliability NERC and Industry Move in the Right Direction for Greater Reliability

Part 1: Cloud Vendor Selection for Your Life Science Company – Benefits and Risks

Migrating to the Cloud:  What are the Benefits? According to the National Institute of Standards… [more]

Part 1: Cloud Vendor Selection for Your Life Science Company – Benefits and Risks Part 1: Cloud Vendor Selection for Your Life Science Company - Benefits and Risks

FDA Provides Important Clinical Trials Guidance

In the age of electronic documents and electronic signatures, the FDA is still defining and providing… [more]

FDA Provides Important Clinical Trials Guidance FDA Provides Important Clinical Trials Guidance

Misguided FDA Food Regulations Will Hike Costs, Not Safety

2012 will mark another year of aggressive food regulation at the FDA. On tap, salt regulations and industry-wide… [more]

Misguided FDA Food Regulations Will Hike Costs, Not Safety Misguided FDA Food Regulations Will Hike Costs, Not Safety

Obama Executive Order on Drug Supply Misses The Point

The Obama Administration's recent Executive Order Reducing Prescription Drug Shortages states that some… [more]

Obama Executive Order on Drug Supply Misses The Point Obama Executive Order on Drug Supply Misses The Point

Can the U.S. Maintain its Leadership Position in Medical Devices?

According to a recent PwC study, the U.S. medical device industry is facing stiffer competition by rival… [more]

Can the U.S. Maintain its Leadership Position in Medical Devices? Can the U.S. Maintain its Leadership Position in Medical Devices?

Featured Posts

complaintfeature

The Six C’s of Complaints Management Best Practices for Life Sciences

Companies in the Pharmaceutical, Medical Device, and Biotech industries must meet many regulatory requirements for a number of regulatory agencies. Chief among these are requirements from the FDA, as well as from ISO, plus they must meet expectations from a number of other regulatory agencies, depending on the particular market. Implementing best … [Read More...]

2014transmission

NERC and Industry Move in the Right Direction for Greater Reliability

There is a different feel out there in the NERC world, the Electric Reliability Organization (ERO) and the registered entities are working together more than ever since the mandatory implementation of the NERC standards in June 2007. I attended the NERC Member Representatives Committee (MRC) and Board of Trustees (BOT) meetings in Phoenix, AZ on … [Read More...]

cloudfeatured

Part 1: Cloud Vendor Selection for Your Life Science Company – Benefits and Risks

Migrating to the Cloud:  What are the Benefits? According to the National Institute of Standards and Technology, the cloud is “a model for enabling convenient, on-demand network access to a shared pool of configurable computing resources (e.g., networks, servers, storage, applications, and services) that can be rapidly provisioned and released … [Read More...]

SixGroups

FDA Provides Important Clinical Trials Guidance

In the age of electronic documents and electronic signatures, the FDA is still defining and providing guidance for 21 CFR Part 11 concepts it began in 2003.  It seems we all really need to catch up. Now that FDA provides small business webinars and blogs about “the most pressing public health issues of the day”, it is refreshing to note that FDA … [Read More...]

spilled salt shaker

Misguided FDA Food Regulations Will Hike Costs, Not Safety

2012 will mark another year of aggressive food regulation at the FDA. On tap, salt regulations and industry-wide regulations dictating which foods can be advertised on television. In October last year, the FDA announced in the Federal Register that it would begin accepting comments on “approaches to reducing sodium consumption.” The announcement … [Read More...]

Pharmaceutical industry

Obama Executive Order on Drug Supply Misses The Point

The Obama Administration's recent Executive Order Reducing Prescription Drug Shortages states that some health care providers may hoard drugs that are in short supply. I am wondering how this is possible if the drugs are not even available to hoard? In this Executive Order it specifically states that root cause analysis and solutions may be out … [Read More...]

USMedDeviceLeadership

Can the U.S. Maintain its Leadership Position in Medical Devices?

According to a recent PwC study, the U.S. medical device industry is facing stiffer competition by rival countries – mainly Brazil, China and India. However, the U.S. innovation edge may face more threats from an inefficient American regulatory system, according to AdvaMed. Unveiling its "Competitiveness Agenda" at device maker Stryker in … [Read More...]

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