Jeff will lead the business development, sales, marketing and client relations as a senior member of our management team” said Laszlo Kulcsar, Founder & CEO. “We’re delighted to announce that ASI has appointed Jeff Wallack as Chief Commercial Officer as Jeff will drive continued development of our market development especially in the western region of…

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“HTML5 is a markup language used for structuring and presenting content via a Web Browser. It is the fifth and latest major version of HTML which is a World Wide Web Consortium (W3C) recommendation.” https://en.wikipedia.org/wiki/HTML5 The challenge of providing visualization and remote control of production processes has been addressed by various means through the years…

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The world is different today than it has ever been before. Over the past five weeks, unemployment has reached the highest point since the Great Depression and is currently predicted to reach 16% prior to the end of 2020. How can you get your resume noticed by the companies that are still hiring? The first…

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Are you and your company ahead of the serialization curve? The industry experienced a massive rush to prepare for the regulatory requirements of various countries/regions (Drug Supply Chain Security Act or the European Union Falsified Medicines Directive), but are you confident with your system upgrade strategy? Ensuring that your company stays current with serialization requirements…

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In Part 3 of my history of Testing, Commissioning, Validation, Qualification, and Verification, I’ll describe the intent and reality of ASTM E2500 along with some practical advice for implementing an ASTM E2500 risked based approach to qualification of Biopharmaceutical and Pharmaceutical manufacturing systems. The 2006 draft of Science and Risk-Based Approach to Qualification of Biopharmaceutical…

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The FDA process validation guidance, Guidance for Industry: Process Validation- General Principles and Practices, outlines and separates process validation activities in three stages;  Stage 1: Process Design (where Critical Process Parameters or CPPs and Critical Quality Attributed or CQAs are determined), Stage 2: Process Qualification,  and Stage 3: Continued Process Verification (CPV).  The first two…

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Executive Summary Cisco Vicenty tells how the US agency will structure its pilot program for device-makers with less-than-stellar FDA compliance histories that want to use the CMMI maturity model framework to improve the quality and maturity of their manufacturing organizations – and clean up their FDA compliance problems along the way. The FDA – which…

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Over the last two decades, the global pharmaceutical industry has been working to secure the supply chain, through the development and implementation of serialization standards in over 50 markets. Although outliers remain, in general, pharmaceutical products in the impacted markets will have unique identifiers in an attempt to secure the legitimate supply chain from infiltration…

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“Flawless” may not exist on the plant floor, but reviewing your quality process can save money and lives Many years ago, while working on developing a Quality Management System for a large automotive company, we heard a story about how the company had perfected Corrective Action, Preventive Action (CAPA). The company had a clearly defined,…

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