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News Article | May 7, 2017
Site: www.prweb.com

ISPE, the International Society for Pharmaceutical Engineering, released a new Cultural Excellence Report announced at its Conference on Quality Culture and Quality Metrics in Bethesda, Maryland, 25 April 2017. Cultural excellence recognizes quality not as an operational burden or compliance requirement, but as a necessity that allows companies to make decisions that are in the best interest of the patient. The ISPE Cultural Excellence Report shares the vision of quality culture improvements across six dimensions and outlines a series of practical and powerful approaches, practices, and tools to support implementation of the cultural excellence framework, and promote behavioral change that will benefit the patient. “ISPE believes the tools shared in this report provide a practical frame of reference for companies that want to build healthy quality cultures within their organizations”, said John Bournas, ISPE CEO and President. The ISPE Quality Culture Subteam, sponsored by the ISPE Quality Metrics Team and co-led by Dr. Nuala Calnan of the Dublin Institute of Technology and Matt Pearson of Genentech, created this extensive report. The Cultural Excellence Report concentrates on six dimensions of cultural excellence – Leadership and Vision, Mindset and Attitudes, Gemba Walk, Leading Quality Indicators and Triggers, Oversight and Review, and Structural Enablers - a framework first introduced at the ISPE Quality Metrics Summit in April 2015. Dr. Calnan explained “The ISPE Cultural Excellence program was aimed at promoting, coaching, and leading specific desired behaviors while identifying and preventing specific undesired behaviors.” The ISPE Quality Culture Subteam prepared the corporate culture gap analysis from the ISPE Drug Shortage Assessment and Prevention Tool to establish a set of 21 desired key behaviors that support the six dimensions of cultural excellence. The assessment tool featured in the report was designed to help organizations assess the maturity of these behaviors as part of their quality culture program. This report is available in PDF format. The report is $49 for nonmembers. For more information on the ISPE Cultural Excellence Report, please visit the ISPE Bookstore. About ISPE The International Society for Pharmaceutical Engineering (ISPE) is the world’s largest not-for-profit association serving its members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical life cycle. The more than 18,000 members of ISPE are building solutions in the development and manufacture of safe, effective pharmaceutical and biologic medicines, and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters in Bethesda, Maryland, USA, and an operations and training center in Tampa, Florida, USA. Visit http://www.ISPE.org for more information. For more information contact: Maria Robertson Senior Director, Marketing Communications International Society for Pharmaceutical Engineering (ISPE) Tel: +1-301-364-9207 Email: mrobertson(at)ispe(dot)org http://www.ISPE.org


News Article | July 17, 2017
Site: www.prweb.com

The International Society for Pharmaceutical Engineering (ISPE) announced its inaugural Asia Pacific GAMP® Data Integrity Conference, taking place 13 – 14 November at the NTU Alumni Club Auditorium in Singapore. Organized in partnership with the ISPE Singapore Affiliate, this uniquely focused event will take a deep-dive into the expectations and realities of ensuring data integrity across an organization and throughout a product life cycle. “Data integrity has become a pressing issue in pharmaceutical manufacturing with the number of issued warning letters rising,” said John Bournas, ISPE CEO and President. “We’re excited to provide this open forum in Singapore to discuss topics of mutual concern and to learn about the latest tools and technologies available to improve data integrity practices.” The ISPE 2017 Asia Pacific GAMP Data Integrity Conference is crafted around the theme “Data Integrity from Concept to Practice.” The event is designed to be practical and interactive, offering a unique opportunity for industry and regulatory agencies to openly discuss data integrity challenges and solutions for better alignment of industry best practices. The workshops and presentations will be led by a diverse group of expert speakers from around the globe. Attendees will gain insight into the latest requirements and practices to enable robust data management and will have the opportunity to provide feedback on issues affecting the industry. To learn more about this event, visit http://www.ISPE.org/2017-Asia-Gamp-Data-Integrity-Conference. About ISPE The International Society for Pharmaceutical Engineering (ISPE) is the world’s largest not-for-profit association serving its members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical life cycle. The more than 18,000 members of ISPE are building solutions in the development and manufacture of safe, effective pharmaceutical and biologic medicines, and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters in Bethesda, Maryland USA, and an operations and training center in Tampa, Florida USA. Visit http://www.ISPE.org for more information. For more information, contact: Maria Robertson Senior Director, Marketing Communications International Society for Pharmaceutical Engineering (ISPE) Tel: +1-301-364-9207 Email: mrobertson(at)ispe.org http://www.ISPE.org


News Article | July 20, 2017
Site: www.prweb.com

The International Society for Pharmaceutical Engineering (ISPE) announced the release of their latest guidance document, ISPE Baseline® Guide: Risk-Based Manufacture of Pharmaceutical Products (Second Edition). This guide provides a scientific, risk-based approach (based on ICH Q9 Quality Risk Management) for managing the risk of cross-contamination within shared facilities. “The use of multiproduct facilities for the production of pharmaceutical products requires an in-depth understanding of the products, the facilities, the processes, and the equipment and the risks posed by this combination,” said Stephanie Wilkins, Guidance Team Co-lead. “This Baseline® Guide was created to assist manufacturers in assessing and controlling the risk of cross contamination posed by their combination of products, facilities, processes, and equipment so they are compliant with regulations and can confidently deliver products to patients in a safe, timely, and cost-effective manner.” This ISPE Baseline® Guide: Risk-Based Manufacture of Pharmaceutical Products (Second Edition) provides a process that allows manufacturers to assess risk and determine where control strategies are necessary to meet acceptable limits for cross-contamination. It is also intended to offer a more consistent approach on setting acceptable limits to assess the potential of cross-contamination, thus enabling implementation of appropriate controls to facilitate safe and affordable drug product manufacturing. The FDA and EMA were actively involved and reviewed the document prior to publication. The second edition includes changes to support recent ongoing developments. Content has been added to support significant changes in regulations and the application of these regulations. Some information has also been reorganized so that the layout of the guide aligns with the ICH Q9 process. In addition, the application example has been updated based on a heightened understanding and experience with Quality Risk Management, specifically with risk assessments for cross-contamination. Find the newly released, ISPE Baseline® Guide: Risk-Based Manufacture of Pharmaceutical Products (Second Edition) at http://www.ISPE.org/publications-guidance-documents/risk-mapp-management-plan-second-edition. About ISPE The International Society for Pharmaceutical Engineering (ISPE) is the world’s largest not-for-profit association serving its members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical life cycle. The more than 18,000 members of ISPE are building solutions in the development and manufacture of safe, effective pharmaceutical and biologic medicines, and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters in Bethesda, Maryland USA, and an operations and training center in Tampa, Florida USA. Visit http://www.ISPE.org for more information. For more information contact: Maria Robertson Senior Director, Marketing Communications International Society for Pharmaceutical Engineering (ISPE) Tel: +1-301-364-9207 Email: mrobertson(at)ispe(dot)org http://www.ISPE.org


News Article | July 26, 2017
Site: www.prweb.com

The International Society for Pharmaceutical Engineering (ISPE) will host its 2017 Process Validation and Process Validation Statistics Conferences in Bethesda, Maryland, 12 – 15 September. These concurrent events offer comprehensive solutions to process validation lifecycle challenges faced by process validation professionals and statisticians today. “These conferences are invaluable due to the breadth of process validation lifecycle challenges addressed and the opportunity to interact with experienced and leading practitioners and regulatory experts,” said John Bournas, ISPE CEO and President. Designed to expand attendee knowledge of the many facets of process validation, these back-to-back events cover the entire Process Validation Lifecycle - from Stage 1 Process Design through Stage 3 Continued Process Verification (CPV). Benchmarking opportunities abound through shared real-world experiences of successes and challenges from presenters and fellow professionals. Attendees of both conferences will have access to two concurrent evening sessions, a half day regulatory session, a networking reception, and a registration discount. To learn more or to register for these events, visit http://www.ISPE.org/2017-Process-Validation-Conference and http://www.ISPE.org/2017-Process-Validation-Statistics-Conference. About ISPE The International Society for Pharmaceutical Engineering (ISPE) is the world’s largest not-for-profit association serving its members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical life cycle. The more than 18,000 members of ISPE are building solutions in the development and manufacture of safe, effective pharmaceutical and biologic medicines, and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters in Bethesda, Maryland USA, and an operations and training center in Tampa, Florida USA. Visit http://www.ISPE.org for more information. For more information contact: Maria Robertson Senior Director, Marketing Communications International Society for Pharmaceutical Engineering (ISPE) Tel: +1-301-364-9207 Email: mrobertson@ispe.org http://www.ISPE.org


News Article | July 31, 2017
Site: www.prweb.com

The International Society for Pharmaceutical Engineering (ISPE) announced its 2017 Biopharmaceutical Manufacturing Conference, taking place 4 – 6 December in San Francisco, California. This year's event will expand the conversation beyond manufacturing capacity needs to address innovative operational and process development strategies to speed preparations toward launch readiness. “The industry’s ability to operationalize their investments in new and re-designed facilities is central to its success in providing an adequate supply of products to meet patient needs,” said John Bournas, ISPE CEO and President. “As companies prepare for the increased demand for facility improvements, design and manufacturing resources, operational agility and faster time to launch readiness are two key factors that will have an impact on their success.” The 2017 ISPE Biopharmaceutical Manufacturing Conference features three education tracks with comprehensive sessions offering solutions from industry, regulatory, and academic experts. Attendees will gain insight into innovative strategies and approaches designed to improve operational agility and preparation time for launch readiness. Hear regulatory perspectives on how to implement new manufacturing capabilities and advancements to insure timely licensure. Dedicated Program on Advanced Therapeutics: Explore the challenges and opportunities in bringing advanced therapeutics to market. Review the regulatory requirements, unique patient safety issues, and assurance of quality for truly personalized medicines. Analyze unique supply chain manufacturing and testing issues bringing these novel treatments to patients. To learn more about this event and to register, visit http://www.ISPE.org/2017-Biopharmaceutical-Manufacturing-Conference. About ISPE The International Society for Pharmaceutical Engineering (ISPE) is the world’s largest not-for-profit association serving its members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical life cycle. The more than 18,000 members of ISPE are building solutions in the development and manufacture of safe, effective pharmaceutical and biologic medicines, and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters in Bethesda, Maryland USA, and an operations and training center in Tampa, Florida USA. Visit http://www.ISPE.org for more information. For more information, contact: Maria Robertson Senior Director, Marketing Communications International Society for Pharmaceutical Engineering (ISPE) Tel: +1-301-364-9207 Email: mrobertson(at)ispe.org http://www.ISPE.org


The International Society for Pharmaceutical Engineering (ISPE) announced it will host its 2017 Annual Meeting & Expo in San Diego, California USA, from October 29 to November 1. At this signature event, attendees will explore how to navigate organizational and regulatory complexities to drive innovation and advance patient therapies. “This conference has established itself as the biopharmaceutical industry's premier global professional development event, providing invaluable opportunities for peer-to-peer learning and interaction with industry and regulatory leaders,” said John Bournas, ISPE CEO and President. The 2017 ISPE Annual Meeting & Expo delivers a broad spectrum of technical education for multiple levels of expertise across six tracks and more than 80 education sessions. This year’s event features a variety of new sessions and formats to enhance the conference experience, including eight fast-paced 30-minute presentations, seven in-depth workshops, and four new featured topics. In addition to the education, an extensive Expo will showcase more than 200 companies offering advanced technologies and services. Attendees will enjoy a variety of networking and social events, including a 5K charity run/walk to benefit the World Federation of Hemophilia USA and a celebration on the USS Midway. To learn more about this event, visit http://www.ISPE.org/2017-Annual-Meeting. About ISPE The International Society for Pharmaceutical Engineering (ISPE) is the world’s largest not-for-profit association serving its members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical life cycle. The more than 18,000 members of ISPE are building solutions in the development and manufacture of safe, effective pharmaceutical and biologic medicines, and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters in Bethesda, Maryland USA, and an operations and training center in Tampa, Florida USA. Visit http://www.ISPE.org for more information.


News Article | June 15, 2017
Site: www.prweb.com

The International Society for Pharmaceutical Engineering (ISPE) announced the release of their latest guidance document, ISPE Good Practice Guide: Decommissioning of Pharmaceutical Equipment and Facilities. This guide provides an overview of best practices to be used for the decommissioning and disposal of assets ranging from a single item to a whole facility. “The guide also brings together a wealth of information and sample documents that can significantly aid in the decommissioning process,” said Nick Haycocks, Senior Specialist QA, Amgen Inc. “It’s truly a one-stop-shop for information, featuring checklists, templates, and flowcharts currently used in the US and Europe,” added Mark Foss, Central Engineering and Facilities Director, UK Manufacturing, CooperVision. The ISPE Good Practice Guide: Decommissioning of Pharmaceutical Equipment and Facilities describes a risk-based approach for planning and documenting the decommissioning process to meet the requirements of regulatory authorities. This guide also provides examples and sample documents for how this approach can be carried out in practice. The Good Practice Guide is a collection of the practical advice and experience from a wide range of personnel in the life sciences industry. The contributors of this guide have a great deal of experience through site closures, equipment decommissioning, and product/equipment transfers. Find the newly released ISPE Good Practice Guide: Decommissioning of Pharmaceutical Equipment and Facilities at http://www.ISPE.org/Publications-Guidance-Documents. About ISPE The International Society for Pharmaceutical Engineering (ISPE) is the world’s largest not-for-profit association serving its members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical life cycle. The more than 18,000 members of ISPE are building solutions in the development and manufacture of safe, effective pharmaceutical and biologic medicines, and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters in Bethesda, Maryland USA, and an operations and training center in Tampa, Florida USA. Visit http://www.ISPE.org for more information.


News Article | August 17, 2017
Site: www.prweb.com

The International Society for Pharmaceutical Engineering (ISPE) announced its Europe Pharma 4.0 Conference, taking place 23 – 24 November in Verona, Italy. Organized in partnership with the ISPE Italy Affiliate, the conference will focus on preparing the pharmaceutical and biopharmaceutical industry for a full transition to an end-to-end integrated computerized system throughout the manufacturing process. The introduction of advance automation and the increasing interconnectivity of Industry 4.0 is not only revolutionizing the Pharma industry, but also introducing many new challenges and production roadblocks. “Shifting the paradigm to Pharma 4.0 and focusing on the issues specifically surrounding pharmaceutical priorities will lead to improvements in productivity, quality, and security of the supply chain,” said John Bournas, ISPE CEO and President. “The conference will explore the effects of this shift and how the industry will prepare for this next generational challenge.” The ISPE 2017 Europe Pharma 4.0 Conference stems from the ISPE Europe Affiliates’ newly founded special interest group (SIG): “From Industry 4.0 to Pharma 4.0". The Pharma 4.0 SIG started discussions around the issues that the new “automation” factors are causing in the pharmaceutical production chain. Their goal is to specify and differentiate Pharma 4.0 from the common “Industry 4.0” concept, with the focus on maturity level models integrated in the program. The two-day event features an education program focused on core topics, including automation, analytics, end-to-end integration, and workforce 4.0. Attendees will gain insight into a new world of manufacturing, engaging in dialogue with peer groups and senior industry leaders, and learning new manufacturing applications, models, and solutions. To learn more about this event, visit http://www.ISPE.org/2017-Europe-Pharma-Industry-4-0-Conference. About ISPE The International Society for Pharmaceutical Engineering (ISPE) is the world’s largest not-for-profit association serving its members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical life cycle. The more than 18,000 members of ISPE are building solutions in the development and manufacture of safe, effective pharmaceutical and biologic medicines, and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters in Bethesda, Maryland USA, and an operations and training center in Tampa, Florida USA. Visit http://www.ISPE.org for more information. For more information, contact: Maria Robertson Senior Director, Marketing Communications International Society for Pharmaceutical Engineering (ISPE) Tel: +1-301-364-9207 Email: mrobertson(at)ispe(dot)org http://www.ISPE.org


News Article | May 10, 2017
Site: www.prweb.com

The International Society for Pharmaceutical Engineering (ISPE) announced that CEO and President John Bournas was recognized as a top-10 Industry Influencer on The Medicine Maker’s 2017 Power List. The UK publication’s Power List celebrates 100 individuals “involved in bettering the pharma industry and bringing life-changing medicines to market” across four categories. Bournas ranked seventh in the "Industry Influencers" segment. He was recognized for developing ISPE’s global initiatives and business operations, leading organizational efforts in solidifying working relationships with international regulators, and spearheading global initiatives such as the Drug Shortages Prevention Plan. Seven ISPE members were recognized on the 2017 Power List overall, including Andy Skibo, former ISPE Board Chair, and Jim Breen, ISPE Board Secretary. “When I see the names of Andy Skibo and Jim Breen, two of ISPE’s guiding beacons, on the same list, I feel humbled as well as honored with this recognition,” said John Bournas, ISPE CEO and President. The Medicine Maker Power List recognizes 100 pharmaceutical professionals across four categories, each made up of 25 noteworthy professionals—and each with its own top ten: About ISPE The International Society for Pharmaceutical Engineering (ISPE) is the world’s largest not-for-profit association serving its members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical life cycle. The more than 18,000 members of ISPE are building solutions in the development and manufacture of safe, effective pharmaceutical and biologic medicines, and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters in Bethesda, Maryland, USA, and an operations and training center in Tampa, Florida, USA. Visit http://www.ISPE.org for more information.


RALEIGH, N.C., Feb. 15, 2017 /PRNewswire/ -- The Carolina-South Atlantic Chapter (CaSA) of the International Society for Pharmaceutical Engineering (ISPE) will host more than 1,000 life science professionals from major pharmaceutical companies in the southeast and beyond at the 24th...

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