September 2, 2015

FDA CDRH Enforcement: Agency Eases Up a Bit at Home, Looks Overseas

Quality system surveillance inspections dropped about 3% in 2013, the FDA’s Center for Devices and… [more]

FDA CDRH Enforcement: Agency Eases Up a Bit at Home, Looks Overseas FDA CDRH Enforcement: Agency Eases Up a Bit at Home, Looks Overseas

There’s No Such Thing as HIPAA Certification: 4 Myths Surrounding Hosting Providers

As more physicians are integrating their patient EMR with third-party patient portals, they’re looking… [more]

There’s No Such Thing as HIPAA Certification: 4 Myths Surrounding Hosting Providers There's No Such Thing as HIPAA Certification: 4 Myths Surrounding Hosting Providers

Training Management Best Practices for Emerging Life Science Companies

No matter how good your written policies are, or how clean a facility you operate, or how successful… [more]

Training Management Best Practices for Emerging Life Science Companies Training Management Best Practices for Emerging Life Science Companies

FDA’s CDRH Tempers 2015 Goals with a Dash of Pessimism

Unlike its sister Center for Drug Evaluation & Research  (CDER), CDRH’s (Center for Devices &… [more]

FDA’s CDRH Tempers 2015 Goals with a Dash of Pessimism FDA's CDRH Tempers 2015 Goals with a Dash of Pessimism

Are Energy and Utility Companies Ready for Risk Based Compliance?

Part 1: How the NERC Registered Entities are Preparing As we enter into the New Year, many NERC Registered… [more]

Are Energy and Utility Companies Ready for Risk Based Compliance? Are Energy and Utility Companies Ready for Risk Based Compliance?

Are You Ready for 21st Century eMDR Submissions?

If you have been procrastinating on setting up electronic submissions for your adverse event reports… [more]

Are You Ready for 21st Century eMDR Submissions? Are You Ready for 21st Century eMDR Submissions?

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

Featured Posts

FDAoverseasFeatured

FDA CDRH Enforcement: Agency Eases Up a Bit at Home, Looks Overseas

Quality system surveillance inspections dropped about 3% in 2013, the FDA’s Center for Devices and Radiological Health (CDRH) says in its latest stats. It’s not sure why, exactly, but posits it’s due to an increase in inspections overseas. That drains away resources for domestic doings. It’s worth noting that the overall number of inspectional ob … [Read More...]

cloudsecurityFeatured

There’s No Such Thing as HIPAA Certification: 4 Myths Surrounding Hosting Providers

As more physicians are integrating their patient EMR with third-party patient portals, they’re looking for clarifications on many issues in order to stay within the various regulations boundaries and to be Meaningful Use-attested. It can be difficult to differentiate fact from misconception, however, so let’s clarify and dispel 4 myths related spe … [Read More...]

trainingFeatured

Training Management Best Practices for Emerging Life Science Companies

No matter how good your written policies are, or how clean a facility you operate, or how successful you are in the marketplace, it can all fall apart without a strong handle on your organization’s training needs and ability to effectively manage a training program. Ensuring that your staff is properly trained to do their work is a basic e … [Read More...]

2015GoalsFeatured

FDA’s CDRH Tempers 2015 Goals with a Dash of Pessimism

Unlike its sister Center for Drug Evaluation & Research  (CDER), CDRH’s (Center for Devices & Radiological Health) new proposed guidance development and goals for 2015 reminds industry not to get its hopes up too high.  “Our experience over the years has shown that there are many reasons why CDRH does not complete the entire annual agenda of … [Read More...]

featuredRisk

Are Energy and Utility Companies Ready for Risk Based Compliance?

Part 1: How the NERC Registered Entities are Preparing As we enter into the New Year, many NERC Registered Entities are focused on their game plan to prepare and implement the “ERO Enterprise Risk-Based Compliance Monitoring and Enforcement Program.” This new program is different because it places an emphasis on the risk to the bulk power system … [Read More...]

eMDRdeadlineFeatured

Are You Ready for 21st Century eMDR Submissions?

If you have been procrastinating on setting up electronic submissions for your adverse event reports to the FDA, you might want to reconsider that decision. Earlier this year, the FDA published its final rule on MedWatch/eMDR reporting. Although not much has changed in this final rule in regard either to required content, the submission process, or … [Read More...]

complaintsFeatured

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...]

reliabilityFeatured

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...]

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