Enabling Item Level Serialization: Ten Key Steps to Ensure Success

Posted on August 1st, by Gary Lerner in Food & Beverage, Integrity Matters, Medical Devices, Pharmaceuticals.

Item level serialization (ILS) and traceability fosters supply chain integrity. Attaining a common, yet integrated, approach to ILS requires participation and consensus of diverse stakeholders. Consider these ten steps when establishing your ILS and traceability program.



Recall of 62 Million Diabetes Test Strips

Posted on August 1st, by Gary Lerner in Medical Devices, News.

(Washington DC) – The Food and Drug Administration is warning patients with diabetes about the recall of 62 million glucose test strips used to measure blood sugar levels.



Plans to Defeat Piracy?

Posted on December 20th, by Gary Lerner in Food & Beverage, Integrity Matters, Medical Devices, Pharmaceuticals.

Piracy is a business. High quality counterfeits can wreak havoc on brand integrity and customer loyalty. It would be a mistake to think that a counterfeiter would hesitate or even struggle to copy or imitate your packaging or product capabilities.



A Serious Threat to Supply Integrity?

Posted on December 20th, by Gary Lerner in Integrity Matters, Medical Devices, Pharmaceuticals.

Spend enough time investigating brand piracy and you begin to question everything. Often times supply chain participants could easily identify deficiencies and were the first to suspect that merchandise was not the genuine article. Now Seeing is no longer Believing.



Serialization in a CMO Environment

Posted on December 19th, by Gary Lerner in Integrity Matters, Pharmaceuticals.

While a cautious approach seems sensible, waiting is not a viable option, as implementation timelines can be long and require a high level of commitment and coordination to attain success. Add in multiple vendors to the mix, and these issues become even more complicated.



Elements of Brand Integrity Management

Posted on December 19th, by Gary Lerner in Food & Beverage, Integrity Matters, Medical Devices, Pharmaceuticals.

Attaining Brand Integrity means making sure the customer experience lives up to expectations. Pharmaceutical customers above all else expect their products to be safe and effective. The Leading pharmaceutical companies will find ways to make sure the customer experience meets or exceeds customer expectations.



Doctor Pleads Guilty In Misbranded Cancer Drug Case

Posted on December 18th, by Gary Lerner in News, Pharmaceuticals.

US Department of Justice convicts two in cases tying counterfeit cancer drugs to Canadian pharmacy business.



Pharmacy Owner Pleads Guilty

Posted on December 18th, by Gary Lerner in News, Pharmaceuticals.

Jose Carlos Morales co-owner of Pharmovisa, Inc. and PharmovisaMD Inc., pleaded guilty to to paying kickbacks and submitting fraudulent claims for pharmaceuticals to Medicare and Medicaid. According to the Department of Justice, Morales and his co-conspirators submitted false and fraudulent claims to the government agencies, which amounted to approximately $23,367,775.



FDA Seeks UDI Amendment Comments

Posted on December 17th, by Gary Lerner in Medical Devices, News, Regulations.

Last month FDA published an amendment to its July 10, 2012 UDI proposed rule (77 FR 40736). The amendment moves up the dates of compliance. Comments on this amendment to the proposed rule are due by December 19, 2012.



FDA Issues Proposed UDI Regulation

Posted on December 17th, by Gary Lerner in Medical Devices, News, Regulations.

“The unique identification system will enhance the flow of information about medical devices, especially adverse events and, as a result, will advance our ability to improve patient safety.” -FDA Commissioner Margaret A. Hamburg, M.D.