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From HTML5 to hand sanitizer production, our blog covers topics every company could benefit from. No matter if you’re part of the life sciences industry or the health and beauty business, our blog provides information for all types of companies. Peruse our blog today to learn something new.

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Automated Systems, Inc. appoints Jeff Wallack as Chief Commercial Officer

By webadmin / November 24, 2020 /

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 Providing Flexibility on the Plant Floor

By Jozsef Megyeri / June 30, 2020 / Comments Off on HTML5 is Providing Flexibility on the Plant Floor

“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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Emergency Hand Sanitizer Production – Regulations, Requirements and Manufacturing Opportunities

By Eve Kulcsar / May 7, 2020 / Comments Off on Emergency Hand Sanitizer Production – Regulations, Requirements and Manufacturing Opportunities

The current public focus on personal hygiene and cleanliness can present a significant revenue opportunity for businesses that have the flexibility to manufacture hand sanitizer. Conceptually, the Big Message from FDA is simple; assist in COVID-19 prevention by making hand sanitizer, and FDA will not pursue enforcement actions. In the guidance document released by FDA…

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Writing a resume to get hired during unprecedented times

By Holly Hubsky / May 1, 2020 / Comments Off on Writing a resume to get hired during unprecedented times

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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Global Serialization, we’re well past the US regs, but there is still work to be done

By Ray Rugebregt / April 21, 2020 / Comments Off on Global Serialization, we’re well past the US regs, but there is still work to be done

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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Testing, Commissioning, Validation, Qualification, or Verification? A Brief History – Part 3

By Nels Hackl / February 10, 2020 / Comments Off on Testing, Commissioning, Validation, Qualification, or Verification? A Brief History – Part 3

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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Continued Process Verification (CPV): The often overlooked (but much needed) 3rd Stage of Process Validation

By Pablo Quiles / January 3, 2020 / Comments Off on Continued Process Verification (CPV): The often overlooked (but much needed) 3rd Stage of Process Validation

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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FDA’s Case For Quality Head Explains The Agency’s 2020 Maturity Model Pilot For Medical Device Manufacturers

By Liza Nelson / December 5, 2019 / Comments Off on FDA’s Case For Quality Head Explains The Agency’s 2020 Maturity Model Pilot For Medical Device Manufacturers

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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Next Steps For Serialization In The Pharma Supply Chain

By Liza Nelson / November 12, 2019 / Comments Off on Next Steps For Serialization In The Pharma Supply Chain

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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FDA Compliance Management – Perfecting CAPA

By Liza Nelson / November 5, 2019 / Comments Off on FDA Compliance Management – Perfecting CAPA

“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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