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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.


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 | 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.


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 | 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


News Article | October 29, 2016
Site: www.prweb.com

HOLLOWAY AMERICA, a custom fabrication company specializing in pressure vessel design and tank repair, will attend the International Society of Pharmaceutical Engineers (ISPE) Boston Area Chapter’s 25th Annual Product Show Oct. 5th at Gillette Stadium in Foxborough, Ma. With over 8,000 in attendance, the ISPE Boston chapter’s flagship show is the largest one-day product show of its kind in the country. HOLLOWAY representatives will be available at space E9 to answer questions about the company’s popular stainless steel fittings, bioreactor vessels and biopharm process equipment, stainless steel atmospheric tanks and repair services. “The Boston ISPE show is one of the biggest of the year,” said HOLLOWAY Director of Engineering Evelyn Gayer. “Our team is looking forward to talking with attendees about ways we can safely, effectively streamline their production processes.” She noted that attendees typically want to discuss everything from pressure vessel repairs to replacing original pressure vessel components to the company’s custom vessel design and fabrication services. “We love to talk shop with people involved with ISPE, so we’re excited to answer any questions and discover new ways HOLLOWAY can help our peers,” added Gayer. The ISPE Boston Chapter Product Show boasts a day full of engaging sessions and keynotes, hundreds of industry leaders in a large exhibit hall, an innovation stage, one of the largest job fairs and networking events in the area, a charity drive and a famous after-party. Conference organizers have also scheduled some extra fun into the event. A stop by the Champions for Charity pavilion in the West Clubhouse will give attendees an opportunity to meet New England Patriots alumni Scott Zolak, Jermaine Wiggins and Ronnie Lippett, along with current Patriots cheerleaders. The after-party at Splitsville/Howl At The Moon is located at Patriot Place and features pristine bowling alleys and dueling pianos. Guests can also get autographs and pictures with Patriots Defensive End Rob Ninkovich. The ISPE Boston Chapter Product Show will be packed full of activity from 8 a.m. to 9:30 p.m. on Wednesday, Oct. 5. Coffee and breakfast will be served in the morning, and education classes, exhibit halls and career fairs will be open throughout the day. The schedule of events for the day is as follows: Those interested in attending the product show can register online at ispeboston(dot)org. For details about HOLLOWAY AMERICA’s pressure vessels, repair services or original pressure vessel components, contact a representative at 417.863.0077 or by email at info(at)HollowayAmerica(dot)com.


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

The International Society for Pharmaceutical Engineering (ISPE) and its Facility of the Year Awards (FOYA) program today announced its 2017 Category Award winners: FOYA’s judging panel has also awarded Honorable Mentions to: This premier global awards program recognizes innovation and creativity in manufacturing facilities serving the regulated healthcare industry. Projects selected for the FOYA program set the standard for pharmaceutical facilities of the future by demonstrating excellence in facility design, construction, and operations. “We are proud to honor these eight organizations that share ISPE’s commitment to innovate and advance pharmaceutical manufacturing technology for the benefit of all global patients,” said John Bournas, ISPE CEO and President. 2017 Facility of the Year Category Award Winners Abbott is the winner of the Operational Excellence category for success of its “Operational Excellence – A New Quality Approach" project initiated at the Abbott Diagnostics facility in Longford, Ireland. The site has increased productivity, improved changeover efficiencies, eliminated backorders, and enhanced product quality--while also reducing cost per unit, cycle times, equipment down-time, and inventory holdings. Bristol-Myers Squibb won the Facility Integration category for its Biologics Development Building and the Clinical Manufacturing Building project located in Devens, Massachusetts, USA. These facilities were recognized as outstanding examples of how to integrate new capabilities within an existing plant through careful design, good collaboration, as well as creative engineering. Cook Pharmica is the winner of the Equipment Innovation category for its Flexible Filling Line project in Bloomington, Indiana, USA. This collaborative development between owner, suppliers, and engineering experts delivered a novel application of commercially available and custom developed equipment innovation manufacturing solutions that drove superior commercial market changing technology and supply chain flexibility in a unique “ready-to-use” vial platform. Eli Lilly and Company has been awarded winner of the Process Innovation category for its Continuous Direct Compression Manufacturing Kits 2 & 3 project located in Indianapolis, Indiana, USA and Carolina, Puerto Rico. Their forward thinking approach brought on the implementation of Continuous Direct Compression (CDC) Process and other process innovations in their oral solid dose (OSD) facilities across their manufacturing network. Eli Lilly and Company has also been named winner of the Facility of the Future category for its process development, production platform commitment, and deployment of three replicate operational continuous oral solid dosage (OSD) production facilities. Fundamental to the success of the project was the development of the progressive mass balance control scheme anchored by advanced automation and PAT technology— key to insuring consistent control, low process variability, and high quality assurance. Jazz Pharmaceuticals Ireland Limited is the winner of the Project Execution category for its creation of a greenfield manufacturing facility in Athlone, Ireland. Having no prior experience internally on building or operating a manufacturing facility, the Jazz “Project Rock” approach was highly pragmatic, and a model for lean project execution and integration of the investment from “project” phase to licensed GMP operations. Nephron Pharmaceuticals Corporation received an Honorable Mention for its facility in West Columbia, South Carolina, USA. The Nephron SC project was recognized for its use and integration of a suite of industry leading technologies such as laser guided vehicles, automated warehousing, robotics to eliminate human intervention, and track and trace technology. Novartis-Penn Center for Advanced Cellular Therapies received an Honorable Mention for its Center for Advanced Cellular Therapies (CACT) project in Philadelphia, Pennsylvania, USA. The facility leverages pharmaceutical engineering principles to successfully merge academic, corporate, and medical considerations thereby creating an innovative center to advance personalized medicine. PT. Kalbio Global Medika received an Honorable Mention for its greenfield Biotech Facility project in Jakarta, Indonesia. Kalbio’s young and highly motivated project team is an outstanding example of the “can do spirit”. It is a fine demonstration of the talent and potential for biomanufacturing in the region. The 2017 FOYA Category Winners will be formally recognized at the ISPE Facility of the Year Awards Banquet on 6 June 2017, in Arlington, Virginia, USA. The banquet, held in conjunction with the ISPE/FDA/PQRI Quality Manufacturing Conference, will feature presentations from the FOYA judging panel and other noted industry leaders. The 2017 FOYA Overall Winner will be announced at the 2017 ISPE Annual Meeting & Expo from 29 October – 1 November in San Diego, California, USA. Winners will also have the opportunity to make presentations during educational sessions at the ISPE Annual Meeting. About the ISPE Facility of the Year Awards Program Established in 2004, The Facility of the Year Awards (FOYA) recognize state-of-the-art projects utilizing new, innovative technologies to improve the quality of products, reduce the cost of producing high-quality medicines, and demonstrate advances in project delivery. The FOYA program provides a platform for the pharmaceutical science and manufacturing industry to showcase its accomplishments in facility design, construction, and operation, while sharing the development of new applications of technology and cutting-edge approaches. Visit http://www.FacilityOfTheYear.org for more information. 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 lifecycle. 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 | February 27, 2017
Site: www.prweb.com

The International Society for Pharmaceutical Engineering (ISPE) announced its inaugural Conference on Quality Culture and Quality Metrics, taking place 25 – 26 April in Bethesda, Maryland USA. This uniquely focused event will feature high-level sessions, aligned with the FDA’s revised draft guidance on quality metrics and ISPE’s on-going Quality Culture and Quality Metrics Initiatives. In-depth workshops will provide insights on the Six Dimensions Framework in the Cultural Excellence report. “Sustainable production of high quality, available products demand a knowledgeable and devoted mindset to improve quality culture,” said John Bournas, ISPE CEO and President. “This conference was crafted to provide an enriched understanding of how quality metrics and quality culture are used throughout the pharmaceutical industry to monitor quality management systems and processes, and drive continuous improvement efforts in drug manufacturing.” The ISPE Conference on Quality Culture and Quality Metrics will feature a collection of practical, powerful tools and a comprehensive, behavior-based approach for improving quality culture as a means of delivering enhanced quality outcomes. This event will also deliver the latest data and insights for operationalization of quality metrics across the supply chain. There will also be a high-level industry panel on quality culture, and special sessions on quality metrics with industry leaders and three FDA experts. To learn more about this event, visit http://www.ISPE.org/2017-Quality-Culture-Quality-Metrics-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 lifecycle. 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...


News Article | November 8, 2016
Site: www.prweb.com

G-CON today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office for its Patent Application 12/856,888 entitled Modular, Self-Contained, Mobile Clean Room. G-CON was founded on this proprietary platform approach that transforms the way that cleanrooms are designed and built. G-CON’s in-house engineering team designs the PODs to meet the customer’s specifications followed by the PODs being built and qualified entirely in G-CON’s facilities. G-CON was the first to invent and offer this novel turnkey approach of delivering prefabricated cleanrooms, which are generally built in place and are provided as construction projects with attendant delays and unpredictable costs. The G-CON POD approach allows for a much more predictable result in terms of costs, schedule and quality since the same team builds each POD with the same core materials thereby avoiding product variability due to changing raw materials and transient construction crews. The U.S. Patent and Trademark’s Notice of Allowance validates the G-CON platform as a novel way to produce cleanrooms. Such a finding is the latest endorsement of the cleanroom POD approach with G-CON having won several awards for product innovation in the pharmaceutical and biopharmaceutical industry including but not limited to: The ISPE’s Faciltiy of the Year Award for Equipment Innovation 2016, Interphex’s Best Technology Innovation 2015, Pharmaceutical Processing’s Facility of the Year, and a Finalist in the category for Best Collaboration Partnerships for the 2016 BioProcess International Awards. Maik Jornitz, President and CEO of G-CON Manufacturing stated: “We are delighted to receive the Notice of Allowance from the U.S. Patent and Trademark Office. Such a Notice further validates our innovative POD approach. It motivates us to develop other cleanroom platforms, as well as unique facility concepts with our partners. When we started in 2009 we had one product for one application. Our product portfolio now includes a much larger variety of standard PODs, which can be configured to the needs of our customers. The current POD range meets the requirements of a number of applications, including bioprocessing, oral solid dosage forms, predesigned filling and single-use technology unit operations and the strict containment needs for ADCs and cell therapies. This notice and ultimately the patent strengthens our position of being the most advanced and largest prefabricated cleanroom provider globally.” About G-CON Manufacturing G-CON Manufacturing designs, builds and installs prefabricated, autonomous cleanroom PODs®. G-CON’s cleanroom POD® portfolio provides a number of dimensions for a variety of uses, from laboratory environments to personalized medicine and production process platforms. The POD® cleanroom units surpass traditional cleanroom structures by virtue of their scalability, mobility and the possibility of repurposing the PODs® once the production process reaches its lifecycle end. For more information, please visit the G-CON’s website at http://www.gconbio.com.

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