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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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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…
Read MoreAre 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…
Read MoreIn 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…
Read MoreThe 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…
Read MoreExecutive 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…
Read MoreOver 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…
Read More“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,…
Read MoreFew industries are scrutinized by regulators as carefully as the pharmaceutical industry. Manufacturers of medicine should, for example, be able to demonstrate at any time how they meticulously follow the Standard Operating Procedures (SOPs), and how patient safety is never compromised. But how do you ensure you have the most current, accurate, and complete data…
Read MoreAn Automation Engineer utilizes technology to improve, streamline and automate a manufacturing process. They are responsible for planning, implementation, and monitoring of such technology. Let’s take a closer look at the details of automation and the role of an Automation Engineer. What is Industrial Automation Exactly? At its most basic level, automation consists of three…
Read MoreASI is proud to once again sponsor the Chicago Freedom Summit, hosted by AM 560, The Answer. The 2019 Chicago Freedom Summit is to take place in Itasca, Illinois on November 2nd, 2019. Once again, you will have the chance to hear the big issues facing the country and the conservative movement discussed and debated,…
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