The Shift to Monitoring BioPharma Product Quality Throughout Their Lifecycle For years, pharmaceutical manufacturers have talked about the last mile. With mail order pharmacies, direct to pharmacy/patient channels, and things like orphan drug clinical trials, the last mile can be complex yet largely unregulated. The other end of the pharmaceutical supply chain, the inbound supply of ingredients, has received more solid guidance from regulators. In 2000, major markets including the EU and US supported the ICH Q7 initiative by publishing their own guidelines specifically for GMP for APIs. Although GMP guides have included some elements on storage and distribution, the only GDP focused guide was the WHO Guide on GTDP for Pharmaceutical Starting Materials until recently.
Read More →Q&A eBook with QT9 Software: Benefits of Automating Your Quality Management System with Software
Industry regulations can make life for medical device manufacturers very challenging. Regulations are there for a reason and are required to grow and improve your business. This is different than in most manufacturing sectors. Demonstrating compliance to these various regulations requires meticulous record management. As an example; the ability to easily manage and maintain your records for Product Design, can provide an organization with a competitive edge for getting new products, or enhancing existing products for their market. QT9 Software will be speaking at our American Medical Device Summit taking place October 4-5th, 2017 in Chicago, IL. The presentation topic will be on the “Benefits of Automating Your Quality Management System with Software.” We asked Brant a few questions about quality management, issues medical device manufacturers are facing today, and how to save time and money in the industry. Please, take a look at our Q&A eBook with Brant Engelhart from QT9 Software below!
Read More →Webinar: ISO 9001:2015: An Implementation Perspective
Is your organization ready for ISO 9001:2015? Have you begun preparing to transition or get certified to the new standard? This webinar by Intelex Technologies features Peter Merril, one of North America’s foremost authorities on the implementation of ISO 9001. Peter shares his expertise and insights on how to proactively jump-start your transition. The webinar topics discussed include: An outline of the structure of the new ISO 9001:2015 standard; Discussion of interpretations and new terminology; and Practical tips to help organizations transition and meet the requirements of ISO 9001:2015. Watch Now Below!
Read More →Case Study: How to Get Started with Quality Performance Management
In an effort to catch quality nonconformances earlier and reduce cost, companies are focused on collecting as much performance data as possible. This data is often leveraged by quality and continuous improvement professionals to derive intelligence. Unfortunately, the conversion from data into intelligence is where many fall short. LNS Research’s recent studies and discussions with industry executives have shown that despite any data collection efforts and technological capabilities, many companies lack a strong performance management foundation for transforming information into something actionable. To gain a better understanding of the foundations of a strong quality performance management program, this report will focus on highlights from the recent LNS Research Global Executive Council meeting. Specifically, readers of this case study will gain insights into the following areas of quality performance management: An overview of Accuride’s quality performance management program Identifying the right metrics for your organization The importance of focusing on both process and product losses An understanding of how much data is required to get started Recommendations and the role of technology in performance management View the full case study below!
Read More →Infor CloudSuite Industrial (SyteLine) for Medical Devices
For medical device manufacturers, advancing and maintaining information management solutions that are compliant with an evolving set of FDA regulatory standards is a constant challenge. As you strive to manufacture high-quality medical devices, you need an enterprise resource planning (ERP) solution that can help you minimize compliance risk, as you maintain profitability, drive efficiencies, and streamline all parts of your business. This article will delve into: Upholding GMP quality standards; Maintaining regulatory compliance; Using integrated electronic records; and Meeting regulatory requirements. To find out more about how to reduce compliance risks and meet regulatory requirements, check out the white paper by Copley Consulting Group below:
Read More →Top Medical Device Industry Regulations—and Why They Matter
It’s important to keep up with compliance mandates because the US Food and Drug Administration (FDA) keeps a close watch on the medical device industry. If there is an accident involving your devices, it could damage the lives of your patients and the reputation of your company. This article focuses on the most significant FDA quality regulatory programs to be aware of, and tips on how to avoid fines and court action for non-compliance. Read the full article here. For more information about keeping up with regulations, visit The Copley Consulting Group and Infor CloudSuite Industrial for Medical Devices.
Read More →Infographic: Respiratory Concerns with Welding
Capturing dust and fumes generated during welding presents a unique challenge, and, unfortunately, there are many health problems that can be caused by an overexposure to welding fumes. Though capturing dust and fumes is a challenge, it is important to have a safe dust collection system to rid your work environment of these harmful pollutants. Still not convinced that air pollution control is important? Check out the Camfil infographic below to explore the top 5 respiratory concerns associated with welding, followed by a solution that works. Hear more from Camfil by joining the discussion at the American Automotive Summit on November 10-11 in Detroit.
Read More →Infographic: Building a Culture of Quality in Biomanufacturing
Quality management is a key focus at the American Biomanufacturing Summit 2016. Manufacturers are facing increased pressure to reduce product costs while producing “bio-better” drugs that have a vastly improved pharmacological profile. By implementing a quality management system biomanufacturers will be able to build consistency into their processes, improve efficiency, ensure profitability and drive operational and competitive advantages. Implementing a quality management system is no easy feat, the process requires an organizational evolution and involves the optimization of procedures, processes and resource allocation. To enable these changes an organization must first work to build an organizational culture that focuses on quality. The first infographic in our quality series has been created from the information presented by Tony Mire-Sluis, Vice President, North America, Abingdon, Singapore, Contract and Product Quality, Amgen Inc., at the American Biomanufacturing Summit last year. Find out more about building a Culture focused on Quality at the American Biomanufacturing Summit 2016!
Read More →Infographic: 5 Questions that Lead to Better Supplier Management & Performance
Take a closer look at the infographic: SQA Services- Supplier Performance Management (1) Find out more about SQA Services online, or Join SQA at the upcoming American Manufacturing Summit 2016, taking place on February 29th – March 1st in Chicago!
Read More →Balancing Competing Priorities in Medical Device Manufacturing
Medical device manufacturers must consistently work to balance competing priorities; everything from product development, regulatory compliance and quality to marketing. Managing these priorities in disparate individual silos leads to a lack of efficiency, communication and productivity. As a result, many manufacturers are turning to holistic enterprise operation solutions to streamline their processes from innovation through to the product end of life. Dassault Systèmes Industry Solution Experiences for Life Sciences powered by the 3DEXPERIENCE® platform provide a major leap forward with a Single Source of Truth (SSOT) environment that spans the entire product lifecycle from conceptual design to end of life. These solutions for Life Sciences enhance global collaborative sharing, making compliance and innovation complementary processes that contribute to each other’s and the company’s success. The Dassault Systèmes whitepaper “TRANSFORMING MEDICAL DEVICES WITH SUSTAINABLE INNOVATION”outlines some of the key benefits of this integrated technology for medical device manufacturers: Manage and facilitate innovation without compromising quality and safety through one cohesive platform that allows collaboration of design information and visibility across the product lifecycle from ideation to end of life. Increase patient safety by reducing the number and severity of recalls and field actions Increase business agility by streamlining design collaboration and managing team activities to align project goals and user requirements. Speed compliance processes by integrating regulations into product development (design for compliance) and e-submission. Accelerate time-to-market by streamlining the complete regulatory submission and approval process (dossier assembly, review, submission, tracking, and …
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