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FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on vendor audit ...
On July 4th 2025 President Trump signed in the One Big Beautiful Bill Act into law. This legislation is sweeping legislation that impacts all aspects of the United States. However, there are major impacts coming to employers and payroll departments across the ...
In today's regulatory landscape, a strong quality culture is essential for preventing compliance issues and ensuring consistent product quality. Regulatory bodies, including the FDA, increasingly emphasize the need for organizations to establish and maintain a ...
The artificial intelligence technologies granted FDA marketing authorization and cleared by the agency so far are generally called “locked” algorithms that don’t continually adapt or learn every time the algorithm is used. However, the FDA is looking beyond th ...
Due to the growth of electronic records and electronic signatures in CGMP documentation, as well as computer-controlled manufacturing, and medical devices, the US FDA has issued a draft Guidance for Industry, outlining its expectations for increased data integ ...
Whether in an informal setting or a more formal presentation, we all want to bring our “A Game” any time we speak up in a meeting or express our ideas. Plan to join us if: Quite frankly, you hate public speaking You’ve been embarrassed because you get shak ...
The Internet is jam-packed with unwitting but highly visible HIPAA violations committed by Covered Entities on their social media pages like Facebook, their organization’s web site, patient testimonials they post and their responses to patient reviews – whethe ...
Regular (unencrypted) Email and Text Messaging containing Protected Health Information (PHI) are effective engagement and communication tools that patients like and have the right to use. However, unencrypted Emails and Text Messages containing PHI raise signi ...
It sometimes becomes necessary for the medical staff to recommend to the governing board that the medical privileges of a practitioner either be removed or denied. Before such adverse action is taken, it is very important that the practitioner is afforded due ...
More than 170 million Americans have been affected by Breaches of Unsecured Protected Health Information (PHI) since 2009.A Ransomware attack that encrypts PHI is now presumed to be a HIPAA Breach by Federal regulators.HIPAA Breach Notification Content and Tim ...