Benchmarks and Best Practices for Next-Generation QMS

In automation, biomanufacturing, biotechnology, compliance, global quality system, medical device, pharmaceutical, QMS, quality, Quality Management System by Alicia CheungLeave a Comment

In a recent study conducted for Pilgrim,  quality and compliance professionals from the top 2,000 Pharmaceutical, BioTech, Medical Device, and Combination Product companies were surveyed on the “state of the state” of the business, regulatory, and technology landscape of their current quality management systems (QMS). This research provides fresh insights into the state of quality and compliance management in the Life Sciences industry, as well as quantitative data which demonstrates that many Life Sciences companies are preparing for or embracing Next-Generation Quality Management practices.

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Supplier Quality Management: SQM’s Rightful Role in Your Enterprise

In QMS, quality, Quality Management System, supply chain by Cressida Murray1 Comment

While there are many ways to define quality, the most important definition of quality is from the customer’s perspective – perceived quality – as this impacts brand loyalty, revenue, market share, and margins. When customers directly engage with a product, they consciously and subconsciously compare it to previous experiences with similar and dissimilar products. Indirect experiences also influence perceived quality, such as by brand image and social media.

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The Quality 4.0 Impact and Strategy Handbook

In Industry 4.0, manufacturing, quality, Quality Management System by Cressida MurrayLeave a Comment

The most recent decade has seen rapid advances in connectivity, mobility, analytics, scalability, and data, spawning what has been called the fourth industrial revolution, or Industry 4.0. This fourth industrial revolution has digitalized operations and resulted in transformations in manufacturing efficiency, supply chain performance, product innovation, and in some cases enabled entirely new business models. This transformation should be top of mind for quality leaders, as quality improvement and monitoring are among the top use cases for Industry 4.0. Quality 4.0 is closely aligning quality management with Industry 4.0 to enable enterprise efficiencies, performance, innovation and business models. However, much of the market isn’t focusing on Quality 4.0, since many quality teams are still trying to solve yesterday’s problems: inefficiency caused by fragmented systems, manual metrics calculations, quality teams independently performing quality work with minimal cross-functional ownership, and ineffective supplier communication, among others.

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Highlights from the American Automotive Summit: Insights from Volvo, Ford, Toyota, and Kia

In automotive, manufacturing, Plant Location, quality by Cressida MurrayLeave a Comment

The 2017 American Automotive Summit was held on November 28-29 at The Henry, Autograph Collection in Dearborn, MI. It was an extremely successful event and we were proud to have top industry influencers share their thought leadership, including representatives from OEM’s Volvo, Toyota, Ford, and Kia. Here’s what we learned.

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Supply Chain Visibility in Pharmaceutical Outsourcing

In manufacturing, pharmaceutical, quality, supply chain, Uncategorized by Cressida MurrayLeave a Comment

While pharmaceutical companies are ultimately responsible for assuring the control and review of outsourced activities and the quality of purchased materials, many struggle with supply chain visibility due to the complexity of multi-tiered supply chains, inadequate IT systems, limited experience, and resource constraints. The supply chain has gotten increasingly complicated over the past decade. The complexity arises from the entrance of vendors from many countries into the marketplace; vendors that previously played a small or limited role. Mergers and acquisitions have also complicated the supply chain, particularly around quality. 

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Optimizing Temperature Control for Biopharmaceuticals

In biomanufacturing, biotechnology, Generis, industrial markets, innovation, Life sciences, logistics, manufacturer, manufacturing, mfg, pharmaceutical, quality, Quality by design, risk management, safety, supply chain, system design, technology by GenerisLeave a Comment

This article first appeared in BioPharm International, October 1, Caroline Hroncich Today pharma companies are faced with an ever-changing market that includes increased regulatory challenges, globalization, and heightened competition (1). Biopharma companies are rapidly expanding into emerging markets where there are new opportunities for drug development. Conversely, logistics companies must keep up with the demand, ensuring all storage technology is equipped to retain the safety and efficacy of a drug by the time it reaches the end of its journey. This article by World Courier delves into these relevant industry topics: Common considerations for shipping biopharmaceuticals; Temperature management in extreme climates; Recent advancements; and Looking ahead. Learn more about optimizing temperature control for biopharmaceuticals in the article below!  

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An Interview with Bill Remy, Chairman and CEO, TBM Consulting Group

In automation, business, manufacturing, quality, technology by GenerisLeave a Comment

Bill Remy is Chairman and Chief Executive Officer at TBM Consulting and a member of the Board of Directors. He has 30plus years of leadership experience in general management and manufacturing operations. Bill’s areas of expertise include operational performance improvement through LeanSigma deployment in manufacturing operations, supply chain, product development and project management. He has experience in a broad array of business leadership positions across various industries including aerospace and defense, railway, industrial and agricultural equipment, technology and process automation. Bill returned to TBM in the summer of 2011 after working at Invensys as Vice President, Continuous Improvement. Prior to Invensys, Bill led the initiative Bill returned to TBM in the summer of 2011 after working at Invensys as Vice President, Continuous Improvement. Prior to Invensys, Bill led the initiative. This Q&A eBook with Bill Remy will touch on the ways that technology is transforming the manufacturing and supply chain industries, lean manufacturing, technology investments, and best practices for manufacturing managers. Read the full eBook below!  

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Novel Single-Use Systems Allow Faster Powder Transfer and Higher Recovery Rates

In biomanufacturing, biotechnology, design, Generis, manufacturing, mfg, quality by GenerisLeave a Comment

Single use powder containment practices are still in their infancy but keeping your product from cross contamination and reducing airborne particulates is important. Understanding how more modern bag designs can increase safety and speed is a concern to the industry. We looked at the ease of fill along with dispensing times and product loss. ILC Dover’s EZ-Biopac shows a 71% decrease in filling times when measured against an industry standard 2D bag. Due to the non-static film we saw an almost 20% reduction in powder discharge times. In addition, it demonstrates a 33.3% improvement in powder recovery showing reduced waste. Choosing the proper containment system can have a significant impact on plant productivity and profitability. This case study by ILC Dover will delve into: the issues of powder handling; the keys to efficient powder transfer and containment; evaluating potential systems; results; and discharge trials. Find out more about ILC Dover’s EZ-Biopac below!

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Q&A eBook with Bossard: How Will Industry 4.0 Impact Your Supply Chain?

In innovation, Internet of Things, logistics, manufacturer, manufacturing, manufacturing operations, marketing, Q&A, quality, system design, technology by GenerisLeave a Comment

Previously many of these technologies were emerging on their own, but not considered collectively. With a recent push toward an integrated approach, the Internet of Things, the focused effort is much more clear. While efforts are being made to allow technologies to be more interchangeable and data non-exclusive, much of the progress thus far has been disjointed…. This Q&A eBook with Bossard, published by the Generis Group, highlights Industry 4.0, the Internet of Things, full inventory transparency, and more! Bossard creates solutions that enable you to achieve higher productivity while helping you to surface your potential. Connect with Bossard at our American Supply Chain Summit taking place April 24-25th in Orlando, FL. Read the full eBook below:

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QReview: Supply Chain News You Can Use

In cost management, cost reduction, culture, facility, innovation, manufacturer, manufacturing, manufacturing operations, mfg, quality, value chain by GenerisLeave a Comment

Transportation Impact, a 4-time Inc. 5000 company, comes from humble beginnings. In 2008, Keith Byrd and Travis Burt, both then senior-level managers at UPS, left the world’s largest shipping company after nearly two decades, respectively, to launch their own start-up with the mission of providing clients with the most competitive small package contracts in the country. The QReview is a magazine that highlights Transportation Impact’s Quarterly Review learnings and is filled with supply chain news that delves into specific strategies, statistics, and stories relevant to the supply chain industry. Take a look inside and find out how to overcome market challenges, look for optimization opportunities, and more below! Subscribe to QReview here. 

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