CDRH Outlines “Case for Quality” Progress at MedCon

Posted on 20. May, 2016 by .

For the second year in a row I gained exceptional insights into FDA priorities during the annual MedCon event at Xavier University earlier this month. Robin Newman, Director of CDRH’s Office of Compliance presented to the 300+ attendees on the division’s progress with the Case for Quality program that was launched in 2012. Robin’s intro [...]

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Designing a training program.

Understand the “Big Picture” When Designing Training

Posted on 16. May, 2016 by .

Don’t think about training as a one-time event. Too often in the design, development and delivery of instruction, the focus is all around the delivery of classroom instruction or making sure every employee takes the online module. Once delivered, the subject is ignored because “we’ve already had the training on that.” Typically, the group that [...]

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Data Integrity: Seven Critical Validation Documents and Records

Posted on 13. May, 2016 by .

Auditing computer systems for compliance with FDA rules and international standards requires knowing what to look for in validation documentation. Production process control software must be validated for its intended use according to an established protocol. Auditors must be able to identify and review documented evidence of the validation process – including documented evidence of [...]

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Drug Price Investigations Bring Political Spotlight

Posted on 09. May, 2016 by .

Michael Pearson, the outgoing CEO of Valeant Pharmaceuticals, did not show up for a deposition in an ongoing investigation of drug price hikes, and a Senate committee is now threatening to bring about contempt proceedings. This failure to show up has only added fuel to the already burning fire related to price hikes and perceived [...]

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Biosimilars – Current Landscape Pipeline and Reimbursement Perspectives

Posted on 06. May, 2016 by .

Biologics are about to meet their match. Sort of. In 2015, Zarxio® (filgrastim-sndz), which is a biologic, became the first biosimilar approved by the U.S. Federal Food and Drug Administration (FDA).  Zarxio® is similar to, but not an exact copy of, Neupogen® (the biologic reference product). Biologics are composed from living substances resulting in complex [...]

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Automating the SOP Workflow from the DMS to LMS

Posted on 02. May, 2016 by .

I am fortunate to work closely with UL EduNeering’s technology advisors, who work on integration projects such as leveraging batch feeds or webposts to pull HRIS and DMS data into our ComplianceWire® LMS. These projects always require our clients to build a system governance model, and we have programs to help clients map out their [...]

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Independent Auditor Validations

Posted on 25. Apr, 2016 by .

Corrected or not corrected? The IA will know the answer. On November 12, 2015 the Centers for Medicare and Medicaid Services (CMS) released the HPMS memo entitled, Independent Auditor (IA) Validation Process for Medicare Advantage and Prescription Drug Plan Program Audits.  Beginning with the 2015 program audit results and going forward, CMS will require a [...]

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Steadying Confidence for Clinical Trials in India

Posted on 21. Apr, 2016 by .

For over 30 years, with over 500 sites and over a billion people, India was a key destination for clinical trials with its vast treatment naïve clinical population. However, the environment has fluctuated throughout recent years, as The Central Drugs Standard Control Organization (CDSCO), India’s regulatory agency for clinical research, introduced regulations that have shifted [...]

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