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ISPE Good Practice Guide: Good Engineering Practice (GEP)
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ISPE Briefs: Revision to GEP Guide: A Link to QRM-Based C&Q
Since the first edition of the ISPE Good Practice Guide: Good Engineering Practice (GEP) was published in 2008, the pharmaceutical industry and regulators developed industry standards, best practices, and regulatory guidance around topics that relate to Good Engineering Practice, culminating in...
Carolina-South Atlantic (CaSA) Chapter
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ISPE CaSA: Attracting New Talent to the Pharmaceutical Industry
ISPE’s Carolina-South Atlantic (CaSA) Chapter serves members from six different states in the US: North and South Carolina, Tennessee, Alabama, Georgia, and Florida, each with their own unique contributions to the pharmaceutical industry.
ISPE Briefs: New APQ Guide on Management Responsibilities & Review
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ISPE Briefs: New APQ Guide on Management Responsibilities & Review
The second guide in ISPE’s Advancing Pharmaceutical Quality (APQ) series provides a systematic and proactive approach to quantitatively assessing and advancing leadership systems by evaluating the management responsibilities highlighted in ICH Q10 as well as other key leadership components.
ISPE Japan Affiliate: Growing to Meet Market Needs
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ISPE Japan Affiliate: Growing to Meet Market Needs
Japan’s pharmaceutical market is one of the world’s largest and the ISPE Japan Affiliate is helping its members stay connected and current in the ever-changing pharmaceutical industry.
ISPE Iberia Affiliate: Coming Together for Training & Support
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ISPE Iberia Affiliate: Coming Together for Training & Support
The pharmaceutical industry in Spain and Portugal is growing, and the ISPE Iberia Affiliate—which has merged the Spain and Portugal Affiliates to take advantage of synergies between the two Affiliates—is working to train and support this expanding market.
An Inside Look at ISPE’s First Virtual International Hackathon
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An Inside Look at ISPE’s First Virtual International Hackathon
ISPE Emerging Leaders (ELs) held the first fully virtual International Hackathon in February. Fifty-one participants from over 22 countries encountered real-life challenges with working remotely and across time zones. Innovation was key to generating solutions to the problem statement provided by...
ISPE Aseptic Conference Turns 30
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ISPE Aseptic Conference Turns 30
The ISPE Aseptic Conference will celebrate its 30th year with the virtual conference on 15–17 March. The conference has been setting the pace for the evolution of sterile manufacturing processes and technologies in the pharmaceutical industry. This year’s virtual conference platform is providing a...
New Good Practice Guide on Equipment Reliability
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ISPE Briefs: New Good Practice Guide on Equipment Reliability
Equipment reliability helps reduce and manage the risk of failures in equipment, providing focus on availability, fitness for purpose, and cost. Reliable equipment improves the likelihood of achieving reliable manufacturing operations, which improves the supply of critical therapies to patients...
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ISPE Briefs: ISPE Expands Its Popular Webinar Series
To continue meeting the professional needs of ISPE members and with the global increase of virtual events due to COVID, ISPE has expanded its webinar offerings on topics important to ISPE members and industry sponsors.
ISPE D/A/CH Affiliate: Striving to Lead
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ISPE D/A/CH Affiliate: Striving to Lead
The ISPE D/A/CH affiliate Is a Leader in Many Respects, from Its Ever-Increasing Size to the Invaluable Engagement of Its Members, Who Contribute to Ispe’s Growth around the World. Grouping Together Europe’s German-Speaking Countries—Germany (D), Austria (a), and Switzerland (Ch)—It Is Currently...
ISPE Eurasian Economic Union Affiliate
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ISPE Briefs: Introducing the ISPE Eurasian Economic Union Affiliate
In March 2020, the ISPE Eurasian Economic Union (EAEU) Affiliate was officially established. This event was a significant step along the journey to integrate members from Eurasian Economic Union nations into the international pharmaceutical community, as well as another sign of progress in the...
New ISPE Good Practice Guide on Critical Utilities
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New ISPE Good Practice Guide on Critical Utilities
ISPE has published a new Good Practice Guide: Critical Utilities GMP Compliance—How to Be Compliant and Ready to Prove It. Written and reviewed by a team of experts from around the world, the guide is the first of its kind in the industry. Team co-leads Nik Krpan and Rod Freeman talked with...
Coronavirus Collaboration
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Coronavirus Collaboration
Industry interaction is key to understand and cope with the challenges of life during the pandemic. Collaboration (of the social distancing variety) can help manufacturers, consultants, and other members to stay informed and to share information. ISPE...
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ISPE Briefs: ISPE Special Interest Group for Cybersecurity
ISPE has a new special interest group (SIG) to work on IT cybersecurity. The Special Interest Group was formed under GAMP®. A conversation with Jason Young of Silver Bullet Security, who heads the new group, provides details about the Special Interest Group.
Happy Birthday, ISPE
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Happy Birthday, ISPE
Thank you to our Members for supporting ISPE and our mission to ensure the availability of quality medicines worldwide.
ISPE Japan Affiliate
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From West to East & Back: ISPE Japan Affiliate Sees Excellence
Before traveling to the 2019 ISPE Annual Meeting & Expo in Las Vegas, the ISPE Japan Affiliate held its annual phar-maceutical plant tour over five days (21–25 October), visiting two plants in Los Angeles, one in Boston, and one in In-dianapolis.
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Growing Momentum: 2019 ISPE Europe Pharma 4.0™ Conference Report
The 2019 ISPE Europe Pharma 4.0™ Conference held in Manchester, UK, on 20–21 November 2019 was attended by 300 participants, all of whom contributed to the growing momentum for Pharma 4.0™ initiatives. The Pharma 4.0™ Special Interest Group (SIG) and the Program Committee collaborated with the ISPE...
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ISPE Briefs - ISPE Special Interest Group Formed for Cloud Services
A new ISPE Special Interest Group (SIG) has been formed under GAMP® to address the increasing use of cloud services. A conversation with Michael Osburn, Head of Quality at Cornerstone OnDemand, and Judy Samardelis, IT Quality Director at Thermo Fisher...
Women in Pharma® Expands Its Global Reach
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Women in Pharma® Expands Its Global Reach
Since its inception at the ISPE 2016 Annual Meeting & Expo, Women in Pharma® (WIP) has been rapidly growing. In the US and Europe, the society has held numerous Women in Pharma® events at local Affiliates, Chapters, and Annual Meetings & Expos, and it is now establishing a presence in Asia. On 27...
Pharmaceutical Engineering Online
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Pharmaceutical Engineering Online’s First Year
ISPE’s online site for Pharmaceutical Engineering was launched a little over one year ago, in November 2018. Here are some statistics about the site’s success during its first year.
The Future of Biopharma: What Does the Industry Want and Need?
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The Future of Biopharma: What Does the Industry Want & Need?
What Does the Industry Want and Need? Eric S. Langer, President and Managing Partner, BioPlan Associates, Inc., shared these most-needed cell and gene therapy manufacturing improvement, systems, platforms, and infrastructure from his company’s...
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ISPE Briefs - Special Interest Group Formed for Artificial Intelligence
ISPE’s newest Special Interest Group (SIG) will work on the emerging areas of artificial intelligence (AI) and machine learning (ML). The Artificial Intelligence Special Interest Group was formed under GAMP®. A conversation with Eric Staib, Vice President of Compliance and PVAI Compliance Officer...
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Women in Pharma® Milestones
Newest WIP Initiative: The WIP Mentor Circle Program1 Learn More 1. ISPE Women in Pharma®. https://ispe.org/women-pharma
2019 ISPE Biopharmaceutical Manufacturing Conference: Women in Pharma® Focus on Balance
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Women in Pharma® at ISPE Focus on Balance
The second day of the 2019 ISPE Biopharmaceutical Manufacturing Conference in Boston, 18–20 June, kicked off with the Women in Pharma® Balance for Better in Biopharmaceutical Manufacturing breakfast session. Session leader Katherine Leitch, Director of Technical Services, External Manufacturing,...
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ISPE Briefs - ISPE Launches Complimentary Webinar Series
ISPE launched its complimentary Pharma Best Practices Webinar Series in April. The debut was outstanding, drawing more than 850 registrants and over 500 real-time participants representing 62 countries and six regulatory agencies from around the world.
Award-Winning Young Professional Makes Big Professional Impact
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Award-Winning Young Professional Makes Big Professional Impact
Delaware Valley Chapter Executive Vice President Eleanor Small, 34, is a woman with a passion for science and technology. Although still early in her career, she has already accomplished a lot, including being awarded the prestigious Delaware Valley Young Engineer of the Year award for 2019.
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ISPE Briefs - May/June 2019
Another Success for ISPE CaSA Chapter with Life Sciences Tech Conference The ISPE Carolina-South Atlantic (CaSA) Chapter’s 26th Annual Life Sciences Technology Conference was a highly successful event that took place on 12 March 2019 at the Raleigh...
Hiking Boots and Molecules
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Hiking Boots & Molecules
Young Professional Brita Salzmann, a Process Engineer with CRB and member of the ISPE Greater Los Angeles Chapter, loves the challenge of backpacking. She continues to add to her hiking resume, which includes treks across segments of the John Muir Trail in the Sierra Nevada Mountains of California,...
Japan Affiliate’s US Plant Tour
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New Paths & Old in the Japan Affiliate’s US Plant Tour
In conjunction with the 2018 ISPE Annual Meeting & Expo in November in Philadelphia, the ISPE Japan Affiliate held its annual pharmaceutical plant tour. The tour extended over four days from 29 October to 1 November. The group visited four US...
ISPE D/A/CH Affiliate (Germany/Austria/Switzerland) celebrated its 25th anniversary banner
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Focus on Biologics Technology - 2018 ISPE Europe Aseptic Conference
More than 200 attendees from manufacturers and key suppliers attended ISPE’s first European conference on aseptic manufacturing in the old capital of the Austro-Hungarian monarchy, Vienna. Austria is a hot spot for biopharmaceutical manufacturing with a number of global manufacturers or...
New ISPE Guidance Documents
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ISPE Briefs - 3 New ISPE Guidance Documents Debut
ISPE has released three new Guidance Documents: Good Practice Guide: Single-Use Technology provides a road map for efficient implementation of single-use technology (SUT) with minimum disruptions to existing operations. From this Guide, users will...
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International Young Professional Committee 2018 Strategy Recap
It has been an incredibly busy year for the IYPC as we delivered the strategy that was presented to the International Board of Directors at last year’s Annual Meeting in San Diego (and published in the January-February 2018 issue of Pharmaceutical...
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Manufacturing & Control Challenges for Accelerated Development
Enhanced and accelerated regulatory pathways for “Breakthrough Therapies (United States) and “PRIME” medicines (European Union) have been introduced to provide faster access to exciting new therapies developed to treat unmet medical needs.1,2 Jokura et...
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Young Professional Global Event Highlights
Globally, there was one YP event per week for the entire year. There were a great variety of technical events, facility tours, networking evenings (including “speed networking”), as well as career- and leadership-development seminars. YP committee...
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A Growing Global Footprint - ISPE Young Professionals
This year, ISPE Young Professionals held over 60 events in 15 countries, drawing more than 2,000 attendees—an amazing testament to the growth of the YP community. This Special Section details the success of these global activities and the IYPC’s exciting work over the past year.
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2018 ISPE Board Election Results
The ISPE International Board of Directors 2018 election results are in after member voting during the summer. The new slate of officers and directors has been named. Board members govern and chart the Society’s strategic direction during their terms of...
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Facility of the Year Awards: Emphasis on Excellence
Highlights from the stories of the five Category Winners and two Honorable Mentions of this year's Facilities of the Year Awards (FOYA) showcase pharmaceutical industry achievements.
2018 ISPE Annual Meeting & Expo: Welcome to Philly
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2018 ISPE Annual Meeting & Expo: Welcome to Philly
This year's ISPE Annual Meeting & Expo will be held from 4 to 7 November in Philadelphia, Pennsylvania. The theme is "Vision to Reality: Delivering Next-Generation Therapies." The first keynote presentation, by Lars Fruergaard Jørgensen, President and CEO, Novo Nordisk A/S and Honorary Conference...
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Welcome to the ISPE Guidance Document Portal
Gain complimentary access to select ISPE Good Practice Guides through the new portal. Members appreciate the practical knowledge and real-world examples built into our Good Practice Guides, so we made them available for free on the Portal.
Career Building Blocks: Student Chapter to YP Committee- Block
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Career Building Blocks: Student Chapter to YP Committee
Some people are born leaders. They take initiative, become pioneers, start new groups, and develop new ways of doing things, all while motivating others along the way. Young professional Evan Siebenmorgen certainly appears to be one of them. At age 24,...
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Mou Supports Packaging Mass Serialization
ISPE and the Open-SCS Working Group of the OPC Foundation signed a memorandum of understanding at the 2017 Europe Annual Conference in Barcelona. The OPC Foundation is a global not-for-profit...
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2018 ISPE Facilities of the Future Conference Highlights
ISPE's 2018 Facilities of the Future Conference highlighted emerging technologies that are driving change in pharmaceutical manufacturing. Topics included virtual reality, robotics, artificial learning, machine learning, and 3D printing. Education sessions were divided into Industry 4.0 and...
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Focused on Education - ISPE Korea Affliate
Home to more than 51 million people, South Korea is one of the "Four Asian Tigers," along with Hong Kong, Singapore, and Taiwan. These countries experienced rapid expansion and high growth rates beginning in the 1960s, developing into highly advanced economies. South Korea's pharmaceutical industry...
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Mitigating Pharma Risk in the Cloud
ISPE's revised IT Infrastructure Control and Compliance Guide provides comprehensive guidance on regulatory expectations for both traditional and cloud-based IT platforms. Have we done enough?
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Fostering Interaction with ISPE Special Interest Groups
Special interest groups (SIGs) have been an important part of ISPE for many years. SIGs are formed around a specific area of interest, policy, or technology in which members have identified a common challenge. These "microcommunities" foster interaction among a variety of technical domains and...
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On The Road Again -Japan Affiliate's Annual Pharma Plant Tour
The ISPE Japan Affiliate conducted its annual pharmaceutical plant tour last October, visiting four US plants prior to attending the ISPE 2017 Annual Meeting & Expo in San Diego, California. Twenty-one professionals participated from all over Japan,...
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Regulatory Update: Opportunity to Advance Pharma Quality
In March 2017, ISPE submitted an extensive and detailed responseInternational Society for Pharmaceutical Engineering. Response to FDA Docket Number FDA-2015-D-2537. 27 March 2017. https://ispe.org to the 2016 US Food and Drug Administration (FDA) draft guidance "Submission of Quality Metrics...
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Building Community - ISPE Guidance Documents
ISPE was a publishing powerhouse in 2017, producing 10 documents that reflect new titles and refreshed content. Each was made possible by a group of talented professionals, both staff and members, who harnessed laser-focused determination to put current,...
Engaging Members, One at a Time
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UK Affiliate - Engaging Members, One at a Time
These are interesting times for the pharmaceutical industry in the United Kingdom. According to a recent report, the industry employs more than 73,000 people and contributes £30.4 billion ($40 billion) to the British economy, including £4.2 billion ($5.5...
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Meet Young Professional - Lise Heyninck
They say that ongoing growth is the key to a fulfilling career. If that holds true, young professional Lise Heyninck of Belgium has the mindset and drive to build a long and successful career in the pharmaceutical industry.
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ISPE Japan Celebrates 15th Anniversary
ISPE Japan’s Annual Meeting, always the leading event in the affiliate’s calendar, was especially festive this year as the group celebrated its fifteenth anniversary. Held 18 and 19 May at the Toyama International Conference Center in the mountainous...
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ISPE Thailand Co-hosts Cleanroom Testing & Certification Course
ISPE Thailand cohosted “Cleanroom Testing and Certification,” a joint meeting between the affiliate and the Thai Industrial Pharmacist Association on 2–3 May 2017 at the Ambassador Hotel Bangkok. The meeting drew 250 attendees—including 30 from the Thai...
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San Francisco Bay Area Chapter: Supporting A Prosperous Industry
With more than 600 biotech and pharmaceutical companies and 700 medical device and equipment companies, the pharmaceutical industry in the San Francisco Bay Area is flourishing. In 2016 alone, biotechnology and pharmaceutical investment in California,...
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Coming Soon: ISPE Eurasian Economic Union Affiliate
A delegation of pharmaceutical industry professionals and regulators from Russia met with ISPE leadership and staff on 20 July. The visit was arranged by the International Visitor Leadership Program (IVLP), a professional exchange program run by the...
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Preparing for Next-Generation Workforce
It’s a large subject,” admits Ferdinando Aspesi, when we ask him how the Global Pharmaceutical Manufacturing Leadership Forum (GPMLF) plans to address one of the hottest topics in the industry: the workforce of the future. The GPMLF is represented by 65...
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2018 European Annual Meeting Comes to Rome
Rome’s Esposizione Universale Roma, or EUR district, has seen more than its fair share of history. Originally planned as the site of the 1942 World’s Fair under Italy’s prewar fascist regime, the uncompleted EUR suffered extensive damage during the...
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Risk-Based Manufacture of Pharmaceutical Products
The ISPE Baseline® Guide: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP) (second edition), provides a scientific risk-based approach based on ICH Q9: “Quality Risk Management,” for managing the risk of cross-contamination within shared...
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ISPE Turkey Affiliate - A Decade of Achievement
Since the Turkish pharmaceutical industry began applying good manufacturing practices and other international standards in 1984, its performance has been strong. Today, Turkey is home to 300 pharmaceutical companies and 31,000 employees, which produce...
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Training Turkey's Regulators - an Affirmation of Global Citizenship
Antonio Moreira, PhD, is unequivocal about ISPE’s need to encourage members and colleagues around the world. “They have their challenges regarding travel and sometimes political unrest, so anything we can do that demonstrates ISPE’s commitment to support...
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Quality Manufacturing Conference: Aligning with Regulatory Priorities
This is an important event for quality professionals," said Marianne Bock, ISPE’s director of continuing education, describing the fifth annual ISPE/FDA/PQRI Quality Manufacturing Conference, held 5–7 June in Arlington, Virginia, United States. "This...
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A Workshop Leader's Perspective
I was first asked to be a workshop leader for the Quality Manufacturing Conference this past June, I accepted thinking my workshop assignment would be directly related to my professional field of architecture. Instead, I was completely out of my comfort...
Celebrating the 2017 Facility of the Year Awards Winners
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Celebrating the 2017 Facility of the Year Awards Winners
ISPE celebrated the thirteenth annual Facility of the Year Awards (FOYA) banquet on Tuesday, 6 June, with a lively group of participants from the ISPE/FDA/PQRI Quality Manufacturing Conference and beaming category award winners in attendance. Guests...
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Be a Champion - Join the Discussion
Do you want to connect with your colleagues around the globe? Are you seeking information on current trends, hot topics, or how to solve a problem? Then look to the ISPE Communities of Practice! CoPs are virtual libraries, a group of online communities...
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ISPE Europe's Biotech Portfolio
The biotechnology sector is changing the pharmaceutical manufacturing environment: The trend toward personalized medicine is driving smaller batch sizes with higher production volumes. Digitization and integration of GXP computerized systems will...
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Cast Your Ballot! 2017 ISPE Board of Directors Election
In late July 2017, ISPE members will have the opportunity to exercise their right to vote for their 2017 Board of Directors. Current ISPE members will receive electronic ballots by email from Intelliscan, Inc., ISPE’s independent election partner....
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Delaware Valley Chapter Annual Symposium & Exhibition
The Delaware Valley Chapter is proud to host the longest-running vendor exhibition event in the ISPE community. The chapter held its highly anticipated Annual Symposium and Exhibition on 26 February, in Philadelphia, Pennsylvania. The event gave vendors...
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2017 ISPE Europe Annual Conference Reaches New Heights in Barcelona
The ISPE Europe Annual Conference drew more than 500 people to the Crown Plaza Hotel in downtown Barcelona from April 3–5. With 77 education sessions and 50 exhibitors, the gathering was described by at least one attendee as “the best and biggest...
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Warning: Graphic Content
Unless it’s clear that a graphic is in the public domain or can be reprinted without permission, you should assume that it’s protected by copyright. While most people in scientific and technical fields understand that copyright protection applies to the...
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2017 ISPE Training Course Opportunities
Europe Effective and Efficient Deployment of Operational Excellence—Striving for World-Class Performance in Pharmaceutical Operations (T56) 8–9 May Institute of Technology Management (ITEMHSG), University of St Gallen, Switzerland Do you know how to...
Meet the New 2017 ISPE Board of Directors
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Meet the New 2017 ISPE Board of Directors
Pharmaceutical Engineering consulted ISPE’s new Board of Directors Executives to discuss making a difference, member concerns, objectives for 2017, and their visions for the future. In this issue, we talk to: Timothy Howard, Vice Chair: Vice President...
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Meet Young Professional: Takenori Sumi
There’s an adage that says “the first step in getting anywhere is knowing where you want to go.” That certainly seems to hold true for Japanese Young Professional Takenori Sumi, who not only has mapped out the things he must learn to advance his career,...
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East to East: Japan Affiliate on the Road in the USA
First and foremost, the authors wish to express their sincere gratitude to the several persons in the US, former or present seniors in the ISPE global organization, and of course the host plants themselves, without whom the 2016 plant tour could not have...
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2016 ISPE Europe GAMP/Data Integrity Regional Conference
There is still a lot of uncertainty on how to effectively structure a corporate data integrity program. It starts with the definition of the scope and often it ends with parallel work between departments who are owners of different systems along the value chain.
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In Other Words: i.e., e.g., et al., etc.
Four Latin abbreviations are staples of scientific writing: i.e., e.g., etc., et al. Despite their ubiquity, however, their meanings and usage are often confused or misunderstood. How can this be—especially when the terms are used so...
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Meet Young Professional Jamie Sigmon
Jamie Sigmon readily acknowledges that she has done a lot in her young, yet varied career. “I have really been fortunate,” she says. “I have worked as an intern in manufacturing sciences for a regenerative medicine company, I worked in technical...
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2017 Q1 ISPE Training Institute Courses
9–10 March 2017 Are your process control systems fit for use? Using a lifecycle approach for the development and management of process control systems, A Risk-Based Approach to GxP Process Control Systems: Applying the GAMP® Good Practice Guide: A...
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2016 ISPE Facilities of the Future Conference Recap
“The future is already here—it's just not very evenly distributed.” That quote by sci-fi novelist William Gibson captures an important component of ISPE’s successful 2016 Facilities of the Future Conference, which brought together diverse experts sharing...
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2016 Nordic Affiliate Annual Meeting
Henrik Goldschmidt was elected Chair of the ISPE Nordic Affiliate’s Board of Directors at the affiliate’s Annual Meeting, which was held in Copenhagen on 17 November 2016. Congratulations to Henrik, and many thanks to outgoing Chair Anders Widov for a...
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2016 Brazil Affiliate Annual Conference
ISPE was present at the recent Brazil Affiliate Conference, held 24–26 October 2016 in São Paulo. The conference was attended by ISPE CEO and President John Bournas, who spoke on the worldwide status of the biopharmaceutical market and provided an...
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Barcelona Has it All - Host of 2017 ISPE Europe Annual Conference
With deep cultural roots, gorgeous architecture, thriving industry, and inviting climate, Barcelona has it all. From 3–5 April 2017, the city will play host to the ISPE 2017 Europe Annual Conference. “Barcelona is a hot spot for the pharmaceutical...
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Quality State of Mind - ISPE & PEW Release Drug Shortages Report
Quality issues continue to be a driving force behind sterile injectable drug shortages in the United States. This is one of the key conclusions of a Pew/ISPE joint study that interviewed 50 executives from 10 pharmaceutical companies in the United...