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ISPEWEBINARS
ISPE would like to recognize our newly formed Eurasian Economic Union (Eurasia) Affiliate. The Affiliate provides a local forum through which professionals in Russia, Armenia, Belarus, Kazakhstan, and Kyrgyzstan can contribute to the advancement of the SIGN IN - ISPEGUIDANCE DOCUMENT PORTALGLOSSARYPHARMACEUTICAL ENGINEERING HOMECALENDAR Please sign in to continue. Please click on "Forgot Password?" before your 5th attempt to avoid being locked out. If your account is locked out, you must wait 15 minutes before you can attempt to login again. If you need additional assistance, please contact our Member Services Team by email at ask@ispe.org or by phone at (813) 960-2105. An 2021 ISPE ANNUAL MEETING & EXPO 2021 ISPE FACILITIES OF THE FUTURE CONFERENCE 2021 ISPE Facilities of the Future Conference. The 2021 ISPE Facilities of the Future Conference will explore advancements in pharmaceutical technology and what pharmaceutical manufacturing facilities will look like in the future. Featuring technical and inspirational presentations from industry leaders already planning and building “facilities of the future” this conference will look at 2021 ISPE ASEPTIC CONFERENCE Mark your calendar for the 30th Anniversary of the ISPE Aseptic Conference being held on 15–17 March 2021. TRAVEL - 2021 ISPE PHARMA 4.0™ AND ANNEX 1 CONFERENCE Accommodations Vienna Marriott Hotel . Parkring 12a 1010 Vienna Austria Hotel & Reservations: +43 1 515180 Check-in: 1500 Check out: 1200 Parking: On-site parking, fee:€4.80 hourly, €17 daily Guest Room Internet: Complimentary for ISPE attendees INNOVATION, INDUSTRY, AND REGULATORS: MOVING THE INDUSTRY Recap of the Opening Plenary Session of the 2019 ISPE Global Pharmaceutical Regulatory Summit. Industry and regulators came together on 5-6 December for the 2019 ISPE Global Pharmaceutical Regulatory Summit in North Bethesda, Md. Regulators were both presenters and participants in the plenaries and sessions, which shared current and future trends in regulatory ABOUT ISPE IN EUROPE About ISPE in Europe. ISPE in Europe represents the more than 5,000 European members as part of the International Society for Pharmaceutical Engineering. ISPE is the world’s leading not-for-profit association serving its members by leading scientific, technical and regulatory advancement throughout the entire pharmaceutical lifecycle. CLEANROOM | ISPE | INTERNATIONAL SOCIETY FOR The commissioning of a cleanroom is a complex and crucial process with many stages that start after the rooms are designed and built. The ultimate goal of cleanroom commissioning is to confirm that the controlled space will have a robust, clean and safe environment for the processing of drug SOUTH CENTRAL CHAPTER EVENTS- UPDATE RESCHEDULED 26th Annual Golf Tournament & Awards Banquet Itinerary: 11:00 - 12:30 pm Check-In & Registrations 1:00 pm Shotgun Start 6:00 pm -7:30 pm Buffett Dinner and Awards Ceremony Team Scramble Sponsor Your Own Team or We Will Set You Up First Place Awarded HOMEPAGE | ISPE | INTERNATIONAL SOCIETY FOR PHARMACEUTICALCONFERENCES & TRAININGMEMBERSHIP & COMMUNITIESPUBLICATIONSPROGRAMSABOUTISPEWEBINARS
ISPE would like to recognize our newly formed Eurasian Economic Union (Eurasia) Affiliate. The Affiliate provides a local forum through which professionals in Russia, Armenia, Belarus, Kazakhstan, and Kyrgyzstan can contribute to the advancement of the SIGN IN - ISPEGUIDANCE DOCUMENT PORTALGLOSSARYPHARMACEUTICAL ENGINEERING HOMECALENDAR Please sign in to continue. Please click on "Forgot Password?" before your 5th attempt to avoid being locked out. If your account is locked out, you must wait 15 minutes before you can attempt to login again. If you need additional assistance, please contact our Member Services Team by email at ask@ispe.org or by phone at (813) 960-2105. An 2021 ISPE ANNUAL MEETING & EXPO 2021 ISPE FACILITIES OF THE FUTURE CONFERENCE 2021 ISPE Facilities of the Future Conference. The 2021 ISPE Facilities of the Future Conference will explore advancements in pharmaceutical technology and what pharmaceutical manufacturing facilities will look like in the future. Featuring technical and inspirational presentations from industry leaders already planning and building “facilities of the future” this conference will look at 2021 ISPE ASEPTIC CONFERENCE Mark your calendar for the 30th Anniversary of the ISPE Aseptic Conference being held on 15–17 March 2021. TRAVEL - 2021 ISPE PHARMA 4.0™ AND ANNEX 1 CONFERENCE Accommodations Vienna Marriott Hotel . Parkring 12a 1010 Vienna Austria Hotel & Reservations: +43 1 515180 Check-in: 1500 Check out: 1200 Parking: On-site parking, fee:€4.80 hourly, €17 daily Guest Room Internet: Complimentary for ISPE attendees INNOVATION, INDUSTRY, AND REGULATORS: MOVING THE INDUSTRY Recap of the Opening Plenary Session of the 2019 ISPE Global Pharmaceutical Regulatory Summit. Industry and regulators came together on 5-6 December for the 2019 ISPE Global Pharmaceutical Regulatory Summit in North Bethesda, Md. Regulators were both presenters and participants in the plenaries and sessions, which shared current and future trends in regulatory ABOUT ISPE IN EUROPE About ISPE in Europe. ISPE in Europe represents the more than 5,000 European members as part of the International Society for Pharmaceutical Engineering. ISPE is the world’s leading not-for-profit association serving its members by leading scientific, technical and regulatory advancement throughout the entire pharmaceutical lifecycle. CLEANROOM | ISPE | INTERNATIONAL SOCIETY FOR The commissioning of a cleanroom is a complex and crucial process with many stages that start after the rooms are designed and built. The ultimate goal of cleanroom commissioning is to confirm that the controlled space will have a robust, clean and safe environment for the processing of drug SOUTH CENTRAL CHAPTER EVENTS- UPDATE RESCHEDULED 26th Annual Golf Tournament & Awards Banquet Itinerary: 11:00 - 12:30 pm Check-In & Registrations 1:00 pm Shotgun Start 6:00 pm -7:30 pm Buffett Dinner and Awards Ceremony Team Scramble Sponsor Your Own Team or We Will Set You Up First Place Awarded AGENDA - 2021 ISPE ANNUAL MEETING & EXPO ISPE Membership Benefits. Become a member today. Gain the knowledge and competitive edge you need to succeed in the pharmaceutical and biopharmaceutical engineering industries and join more than 18,000 pharma professionals from around the world by becoming an ISPE Member.SIGN IN
Connecting Pharmaceutical Knowledge Join/Renew Store Cart. Sign in ONLINE LEARNING SEMINARS FOR GLOBAL PHARMACEUTICAL These recorded online learning webinars span 10 topics pertinent to global pharmaceutical manufacturing professionals.Find case studies with in-depth knowledge, best practices from top-notch seminars and authors of ISPE Guidance Documents. GOOD PRACTICE GUIDES Good Practice Guide: Knowledge Management in Pharmaceutical Industry. ICH Q10 outlines three objectives: achieve product realization, establish and maintain a state of control, and facilitate continual improvement. Embracing these objectives can be best achieved using the dual enablers, Knowledge Management (KM) and Quality Risk Management(QRM).
TRAVEL - 2021 ISPE PHARMA 4.0™ AND ANNEX 1 CONFERENCE Travel Vienna Marriott Hotel. ISPE Membership Benefits. Become a member today. Gain the knowledge and competitive edge you need to succeed in the pharmaceutical and biopharmaceutical engineering industries and join more than 18,000 pharma professionals from aroundthe world by
QUALITY BY DESIGN
Turning Quality by Design (QbD) into a Practical Reality Training Course. Through group exercises, this course on Quality by Design will delve into implementation and operation of an effective and efficientcontrol strategy.
INTERNATIONAL SOCIETY FOR PHARMACEUTICAL ENGINEERING Roads for CAR-T: Strategies for Cell Based ATMPs Nov 5, 2020 2:00pm ‐ Nov 5, 2020 3:30pm Expiration Date: Nov 30, 2021. Identification: SES310 With a small number of approved cell therapies/ ex-vivo gene therapies and with those approved therapies reaching small patient populations there is not a proven strategy for successful large-scale commercial manufacturing. INTERNATIONAL SOCIETY FOR PHARMACEUTICAL ENGINEERING Digital Transformation to Pharma 4.0 Nov 6, 2020 11:30am ‐ Nov 6, 2020 1:00pm Expiration Date: Nov 30, 2021. Identification: SES408 Out of the wide area of Pharma 4.0, this session will focus on the perspectives inferred from experiences. INTERNATIONAL SOCIETY FOR PHARMACEUTICAL ENGINEERING GAMP® Data Integrity by Design (Part 1) Nov 4, 2020 1:00pm ‐ Nov 4, 2020 2:30pm Expiration Date: Nov 30, 2021. Identification: NA20CENOV1/SES208 GAMP® Data Integrity by Design (Part 1) | Data Integrity by Design is a critical-to-quality initiative for GxP organizations because their business model is driving changes in technology requirements i.e. the globalization of business needs the INTERNATIONAL SOCIETY FOR PHARMACEUTICAL ENGINEERING 2021 Digitell, Inc. All Rights Reserved Privacy Center. × ShoppingCart
HOMEPAGE | ISPE | INTERNATIONAL SOCIETY FOR PHARMACEUTICALCONFERENCES & TRAININGMEMBERSHIP & COMMUNITIESPUBLICATIONSPROGRAMSABOUTISPEWEBINARS
ISPE would like to recognize our newly formed Eurasian Economic Union (Eurasia) Affiliate. The Affiliate provides a local forum through which professionals in Russia, Armenia, Belarus, Kazakhstan, and Kyrgyzstan can contribute to the advancement of the 2021 ISPE ANNUAL MEETING & EXPOSIGN IN - ISPE
Please sign in to continue. Please click on "Forgot Password?" before your 5th attempt to avoid being locked out. If your account is locked out, you must wait 15 minutes before you can attempt to login again. If you need additional assistance, please contact our Member Services Team by email at ask@ispe.org or by phone at (813) 960-2105. An 2021 ISPE FACILITIES OF THE FUTURE CONFERENCE 2021 ISPE Facilities of the Future Conference. The 2021 ISPE Facilities of the Future Conference will explore advancements in pharmaceutical technology and what pharmaceutical manufacturing facilities will look like in the future. Featuring technical and inspirational presentations from industry leaders already planning and building “facilities of the future” this conference will look at ISPE EXPERT XCHANGE: ENABLING PHARMA 4.0™ THROUGH PLUG The ISPE Expert Xchange: Enabling Pharma 4.0 will assess opportunities for the digital transformation of bio-pharmaceutical manufacturing. Learn what business outcomes Pharma 4.0™ enables and what architectural and design principles are behind Pharma 4.0. GAMP TRAINING COURSES GAMP 5 GxP Process Control Training Course. This highly interactive, course describes how the GAMP ® Good Practice Guide: A Risk Based Approach to GxP Process Control Systems , may be applied to achieve process control systems that are fit for intended use and meet current regulatory requirements. The course covers recommended good practice based on a life cycle approach for the developmentCLEANING VALIDATION
1 May 2021. One of the goals of the cleaning validation design phase is to define critical process parameters (inputs) and acceptance criteria (outputs) of the cleaning process. This article explores the selection of a master soil as part of the cleaning validation designphase for
ADVANCING PHARMACEUTICAL QUALITY, CORRECTIVE ACTION Wednesday, 26 May Time:1100 – 1230 ETIRELAND AFFILIATE
Ireland Affiliate. Ireland Affiliate. ISPE has become a leading organisation and the network of choice for those studying or working within the Life Sciences Sector in Ireland, as it continues to deliver acknowledged value and breakthrough insights to its members. Our AGM is on June 3rd at 12 noon. Tickets available on Eventbrite -. NEW GAMP DATA INTEGRITY GOOD PRACTICE GUIDANCE AND Connecting Pharmaceutical Knowledge ispe.org 2 Speakers Sion Wyn Director, Conformity Ltd. Sion Wyn is a well-known and internationally acknowledged specialist in computer systems HOMEPAGE | ISPE | INTERNATIONAL SOCIETY FOR PHARMACEUTICALCONFERENCES & TRAININGMEMBERSHIP & COMMUNITIESPUBLICATIONSPROGRAMSABOUTISPEWEBINARS
ISPE would like to recognize our newly formed Eurasian Economic Union (Eurasia) Affiliate. The Affiliate provides a local forum through which professionals in Russia, Armenia, Belarus, Kazakhstan, and Kyrgyzstan can contribute to the advancement of the 2021 ISPE ANNUAL MEETING & EXPOSIGN IN - ISPE
Please sign in to continue. Please click on "Forgot Password?" before your 5th attempt to avoid being locked out. If your account is locked out, you must wait 15 minutes before you can attempt to login again. If you need additional assistance, please contact our Member Services Team by email at ask@ispe.org or by phone at (813) 960-2105. An 2021 ISPE FACILITIES OF THE FUTURE CONFERENCE 2021 ISPE Facilities of the Future Conference. The 2021 ISPE Facilities of the Future Conference will explore advancements in pharmaceutical technology and what pharmaceutical manufacturing facilities will look like in the future. Featuring technical and inspirational presentations from industry leaders already planning and building “facilities of the future” this conference will look at ISPE EXPERT XCHANGE: ENABLING PHARMA 4.0™ THROUGH PLUG The ISPE Expert Xchange: Enabling Pharma 4.0 will assess opportunities for the digital transformation of bio-pharmaceutical manufacturing. Learn what business outcomes Pharma 4.0™ enables and what architectural and design principles are behind Pharma 4.0. GAMP TRAINING COURSES GAMP 5 GxP Process Control Training Course. This highly interactive, course describes how the GAMP ® Good Practice Guide: A Risk Based Approach to GxP Process Control Systems , may be applied to achieve process control systems that are fit for intended use and meet current regulatory requirements. The course covers recommended good practice based on a life cycle approach for the developmentCLEANING VALIDATION
1 May 2021. One of the goals of the cleaning validation design phase is to define critical process parameters (inputs) and acceptance criteria (outputs) of the cleaning process. This article explores the selection of a master soil as part of the cleaning validation designphase for
ADVANCING PHARMACEUTICAL QUALITY, CORRECTIVE ACTION Wednesday, 26 May Time:1100 – 1230 ETIRELAND AFFILIATE
Ireland Affiliate. Ireland Affiliate. ISPE has become a leading organisation and the network of choice for those studying or working within the Life Sciences Sector in Ireland, as it continues to deliver acknowledged value and breakthrough insights to its members. Our AGM is on June 3rd at 12 noon. Tickets available on Eventbrite -. NEW GAMP DATA INTEGRITY GOOD PRACTICE GUIDANCE AND Connecting Pharmaceutical Knowledge ispe.org 2 Speakers Sion Wyn Director, Conformity Ltd. Sion Wyn is a well-known and internationally acknowledged specialist in computer systems ISPE GUIDANCE DOCUMENTS BY TOPIC An A-Z List of ISPE Guidance Documents by topic. The contents of ISPE’s guidance documents, both printed and digital, are protected by law and intended solely for the personal non-commercial use of the individual purchaser. Reproduction of multiple copies of these materials, in whole or in part, for the purposes of commercial distribution is prohibited.ISPE EXPERT XCHANGE
18 hours ago · ISPE Expert Xchange is a new interactive, collaborative experience that unites forward-thinking pharma professionals with engaged subject matter experts for immersive, topic-focused events. Benefit from years of unparalleled knowledge as leading authorities in their field through: Small Group Discussions. Technical Presentations. GOOD PRACTICE GUIDES Good Practice Guide: Knowledge Management in Pharmaceutical Industry. ICH Q10 outlines three objectives: achieve product realization, establish and maintain a state of control, and facilitate continual improvement. Embracing these objectives can be best achieved using the dual enablers, Knowledge Management (KM) and Quality Risk Management(QRM).
MIDWEST CHAPTER
The Midwest Chapter came to be because of the need of ISPE members, deep in the heartland and far from the heavy concentration of the pharmaceutical-based industry on the East and West coasts, to network with members of their profession. STUDENT INTERNSHIP PROGRAM Student Internship Program. ISPE provides Student Members with information about the companies participating in the Society's Internship Program. This program is designed to assist both students and companies in securing individuals for internships, summer employment, co-op programs, and hopefully permanent employment withinthe pharmaceutical
INNOVATION, INDUSTRY, AND REGULATORS: MOVING THE INDUSTRY Recap of the Opening Plenary Session of the 2019 ISPE Global Pharmaceutical Regulatory Summit. Industry and regulators came together on 5-6 December for the 2019 ISPE Global Pharmaceutical Regulatory Summit in North Bethesda, Md. Regulators were both presenters and participants in the plenaries and sessions, which shared current and future trends in regulatoryIRELAND AFFILIATE
Ireland Affiliate. Ireland Affiliate. ISPE has become a leading organisation and the network of choice for those studying or working within the Life Sciences Sector in Ireland, as it continues to deliver acknowledged value and breakthrough insights to its members. Our AGM is on June 3rd at 12 noon. Tickets available on Eventbrite -. CLEANROOM | ISPE | INTERNATIONAL SOCIETY FOR The commissioning of a cleanroom is a complex and crucial process with many stages that start after the rooms are designed and built. The ultimate goal of cleanroom commissioning is to confirm that the controlled space will have a robust, clean and safe environment for the processing of drugSIGN IN
If you need additional assistance, please contact our Member Services Team by email at ask@ispe.org or by phone at (813) 960-2105.ask@ispe.org or by phone at (813) 960-2105. INTERNATIONAL SOCIETY FOR PHARMACEUTICAL ENGINEERING 2021 Digitell, Inc. All Rights Reserved Privacy Center. × ShoppingCart
HOMEPAGE | ISPE | INTERNATIONAL SOCIETY FOR PHARMACEUTICALCONFERENCES & TRAININGMEMBERSHIP & COMMUNITIESPUBLICATIONSPROGRAMSABOUTISPEWEBINARS
ISPE would like to recognize our newly formed Eurasian Economic Union (Eurasia) Affiliate. The Affiliate provides a local forum through which professionals in Russia, Armenia, Belarus, Kazakhstan, and Kyrgyzstan can contribute to the advancement of the SIGN IN - ISPEGUIDANCE DOCUMENT PORTALGLOSSARYPHARMACEUTICAL ENGINEERING HOMECALENDAR Please sign in to continue. Please click on "Forgot Password?" before your 5th attempt to avoid being locked out. If your account is locked out, you must wait 15 minutes before you can attempt to login again. If you need additional assistance, please contact our Member Services Team by email at ask@ispe.org or by phone at (813) 960-2105. An 2021 ISPE ANNUAL MEETING & EXPO 2021 ISPE ASEPTIC CONFERENCE Mark your calendar for the 30th Anniversary of the ISPE Aseptic Conference being held on 15–17 March 2021. 2021 ISPE FACILITIES OF THE FUTURE CONFERENCE 2021 ISPE Facilities of the Future Conference. The 2021 ISPE Facilities of the Future Conference will explore advancements in pharmaceutical technology and what pharmaceutical manufacturing facilities will look like in the future. Featuring technical and inspirational presentations from industry leaders already planning and building “facilities of the future” this conference will look at INNOVATION, INDUSTRY, AND REGULATORS: MOVING THE INDUSTRY Recap of the Opening Plenary Session of the 2019 ISPE Global Pharmaceutical Regulatory Summit. Industry and regulators came together on 5-6 December for the 2019 ISPE Global Pharmaceutical Regulatory Summit in North Bethesda, Md. Regulators were both presenters and participants in the plenaries and sessions, which shared current and future trends in regulatory 2021 MID-ATLANTIC SCIENCE & TECHNOLOGY VIRTUAL SHOWCASE The Mid-Atlantic Science & Technology (MAST) Showcase will be held virtually this year. Our event focus will be “Rapid Response” reflecting our local business ecosystem's ability to pivot and rise to ongoing Life Science Industry challenges.. Many of our members,friends
CLEANROOM | ISPE | INTERNATIONAL SOCIETY FOR The commissioning of a cleanroom is a complex and crucial process with many stages that start after the rooms are designed and built. The ultimate goal of cleanroom commissioning is to confirm that the controlled space will have a robust, clean and safe environment for the processing of drugIRELAND AFFILIATE
Ireland Affiliate. Ireland Affiliate. ISPE has become a leading organisation and the network of choice for those studying or working within the Life Sciences Sector in Ireland, as it continues to deliver acknowledged value and breakthrough insights to its members. Our next virtual event on May 26th - Current Industry/Regulatory Trends in WFI. SOUTH CENTRAL CHAPTER EVENTS- UPDATE RESCHEDULED 26th Annual Golf Tournament & Awards Banquet Itinerary: 11:00 - 12:30 pm Check-In & Registrations 1:00 pm Shotgun Start 6:00 pm -7:30 pm Buffett Dinner and Awards Ceremony Team Scramble Sponsor Your Own Team or We Will Set You Up First Place Awarded HOMEPAGE | ISPE | INTERNATIONAL SOCIETY FOR PHARMACEUTICALCONFERENCES & TRAININGMEMBERSHIP & COMMUNITIESPUBLICATIONSPROGRAMSABOUTISPEWEBINARS
ISPE would like to recognize our newly formed Eurasian Economic Union (Eurasia) Affiliate. The Affiliate provides a local forum through which professionals in Russia, Armenia, Belarus, Kazakhstan, and Kyrgyzstan can contribute to the advancement of the SIGN IN - ISPEGUIDANCE DOCUMENT PORTALGLOSSARYPHARMACEUTICAL ENGINEERING HOMECALENDAR Please sign in to continue. Please click on "Forgot Password?" before your 5th attempt to avoid being locked out. If your account is locked out, you must wait 15 minutes before you can attempt to login again. If you need additional assistance, please contact our Member Services Team by email at ask@ispe.org or by phone at (813) 960-2105. An 2021 ISPE ANNUAL MEETING & EXPO 2021 ISPE ASEPTIC CONFERENCE Mark your calendar for the 30th Anniversary of the ISPE Aseptic Conference being held on 15–17 March 2021. 2021 ISPE FACILITIES OF THE FUTURE CONFERENCE 2021 ISPE Facilities of the Future Conference. The 2021 ISPE Facilities of the Future Conference will explore advancements in pharmaceutical technology and what pharmaceutical manufacturing facilities will look like in the future. Featuring technical and inspirational presentations from industry leaders already planning and building “facilities of the future” this conference will look at INNOVATION, INDUSTRY, AND REGULATORS: MOVING THE INDUSTRY Recap of the Opening Plenary Session of the 2019 ISPE Global Pharmaceutical Regulatory Summit. Industry and regulators came together on 5-6 December for the 2019 ISPE Global Pharmaceutical Regulatory Summit in North Bethesda, Md. Regulators were both presenters and participants in the plenaries and sessions, which shared current and future trends in regulatory 2021 MID-ATLANTIC SCIENCE & TECHNOLOGY VIRTUAL SHOWCASE The Mid-Atlantic Science & Technology (MAST) Showcase will be held virtually this year. Our event focus will be “Rapid Response” reflecting our local business ecosystem's ability to pivot and rise to ongoing Life Science Industry challenges.. Many of our members,friends
CLEANROOM | ISPE | INTERNATIONAL SOCIETY FOR The commissioning of a cleanroom is a complex and crucial process with many stages that start after the rooms are designed and built. The ultimate goal of cleanroom commissioning is to confirm that the controlled space will have a robust, clean and safe environment for the processing of drugIRELAND AFFILIATE
Ireland Affiliate. Ireland Affiliate. ISPE has become a leading organisation and the network of choice for those studying or working within the Life Sciences Sector in Ireland, as it continues to deliver acknowledged value and breakthrough insights to its members. Our next virtual event on May 26th - Current Industry/Regulatory Trends in WFI. SOUTH CENTRAL CHAPTER EVENTS- UPDATE RESCHEDULED 26th Annual Golf Tournament & Awards Banquet Itinerary: 11:00 - 12:30 pm Check-In & Registrations 1:00 pm Shotgun Start 6:00 pm -7:30 pm Buffett Dinner and Awards Ceremony Team Scramble Sponsor Your Own Team or We Will Set You Up First Place Awarded ISPE PUBLISHES ISPE GOOD PRACTICE GUIDE: KNOWLEDGE ISPE announced the release of its latest Guide, ISPE Good Practice Guide: Knowledge Management in the Pharmaceutical Industry.The Guide focuses on how Knowledge Management (KM) can enable a more effective Pharmaceutical Quality System (PQS). GOOD PRACTICE GUIDES Good Practice Guide: Knowledge Management in Pharmaceutical Industry. ICH Q10 outlines three objectives: achieve product realization, establish and maintain a state of control, and facilitate continual improvement. Embracing these objectives can be best achieved using the dual enablers, Knowledge Management (KM) and Quality Risk Management(QRM).
MIDWEST CHAPTER
The Midwest Chapter came to be because of the need of ISPE members, deep in the heartland and far from the heavy concentration of the pharmaceutical-based industry on the East and West coasts, to network with members of their profession. 2021 ISPE ASIA PACIFIC PHARMACEUTICAL MFG CONFERENCE The 2021 ISPE Asia Pacific Pharmaceutical Mfg Conference will address the challenges for pharmaceutical manufacturers in Asia caused by the global pandemic. Case studies implementing Quality Risk Managementprincipals.
ONLINE LEARNING SEMINARS FOR GLOBAL PHARMACEUTICAL These recorded online learning webinars span 10 topics pertinent to global pharmaceutical manufacturing professionals.Find case studies with in-depth knowledge, best practices from top-notch seminars and authors of ISPE Guidance Documents. GOOD PRACTICE GUIDE: QUALITY LAB FACILITIES ISPE has produced the industry’s first Guidance Document to establish a baseline for the design of Quality Laboratory Facilities. The ISPE Good Practice Guide: Quality Laboratory Facilities is a comprehensive guide to defining design guidelines for Quality Laboratories supporting GxP-regulated facilities producing pharmaceutical products for human and animal applications. ISPE EXPERT XCHANGE: ENABLING PHARMA 4.0™ THROUGH PLUG The ISPE Expert Xchange: Enabling Pharma 4.0 will assess opportunities for the digital transformation of bio-pharmaceutical manufacturing. Learn what business outcomes Pharma 4.0™ enables and what architectural and design principles are behind Pharma 4.0. STUDENT INTERNSHIP PROGRAM Student Internship Program. ISPE provides Student Members with information about the companies participating in the Society's Internship Program. This program is designed to assist both students and companies in securing individuals for internships, summer employment, co-op programs, and hopefully permanent employment withinthe pharmaceutical
IRELAND AFFILIATE
Ireland Affiliate. Ireland Affiliate. ISPE has become a leading organisation and the network of choice for those studying or working within the Life Sciences Sector in Ireland, as it continues to deliver acknowledged value and breakthrough insights to its members. Our next virtual event on May 26th - Current Industry/Regulatory Trends in WFI. INTERNATIONAL SOCIETY FOR PHARMACEUTICAL ENGINEERING 2021 Digitell, Inc. All Rights Reserved Privacy Center. × ShoppingCart
HOMEPAGE | ISPE | INTERNATIONAL SOCIETY FOR PHARMACEUTICALCONFERENCES & TRAININGMEMBERSHIP & COMMUNITIESPUBLICATIONSPROGRAMSABOUTISPEWEBINARS
ISPE would like to recognize our newly formed Eurasian Economic Union (Eurasia) Affiliate. The Affiliate provides a local forum through which professionals in Russia, Armenia, Belarus, Kazakhstan, and Kyrgyzstan can contribute to the advancement of the 2021 ISPE ANNUAL MEETING & EXPOSIGN IN - ISPE
Please sign in to continue. Please click on "Forgot Password?" before your 5th attempt to avoid being locked out. If your account is locked out, you must wait 15 minutes before you can attempt to login again. If you need additional assistance, please contact our Member Services Team by email at ask@ispe.org or by phone at (813) 960-2105. An ISPE GUIDANCE DOCUMENTS BY TOPIC An A-Z List of ISPE Guidance Documents by topic. The contents of ISPE’s guidance documents, both printed and digital, are protected by law and intended solely for the personal non-commercial use of the individual purchaser. Reproduction of multiple copies of these materials, in whole or in part, for the purposes of commercial distribution is prohibited. 2021 ISPE FACILITIES OF THE FUTURE CONFERENCE 2021 ISPE Facilities of the Future Conference. The 2021 ISPE Facilities of the Future Conference will explore advancements in pharmaceutical technology and what pharmaceutical manufacturing facilities will look like in the future. Featuring technical and inspirational presentations from industry leaders already planning and building “facilities of the future” this conference will look at PHARMA 4.0 OPERATING MODEL Pharma 4.0 has been called a new industrial evolution. ISPE's SIG has developed an operating model for moving from one industry to another. Digitization and automation meet very complex product portfolios withlong life-cycles.
ISPE EXPERT XCHANGE: ENABLING PHARMA 4.0™ THROUGH PLUG The ISPE Expert Xchange: Enabling Pharma 4.0 will assess opportunities for the digital transformation of bio-pharmaceutical manufacturing. Learn what business outcomes Pharma 4.0™ enables and what architectural and design principles are behind Pharma 4.0.CLEANING VALIDATION
1 May 2021. One of the goals of the cleaning validation design phase is to define critical process parameters (inputs) and acceptance criteria (outputs) of the cleaning process. This article explores the selection of a master soil as part of the cleaning validation designphase for
ADVANCING PHARMACEUTICAL QUALITY, CORRECTIVE ACTION Wednesday, 26 May Time:1100 – 1230 ETIRELAND AFFILIATE
Ireland Affiliate. Ireland Affiliate. ISPE has become a leading organisation and the network of choice for those studying or working within the Life Sciences Sector in Ireland, as it continues to deliver acknowledged value and breakthrough insights to its members. Our next virtual event on May 26th - Current Industry/Regulatory Trends in WFI. HOMEPAGE | ISPE | INTERNATIONAL SOCIETY FOR PHARMACEUTICALCONFERENCES & TRAININGMEMBERSHIP & COMMUNITIESPUBLICATIONSPROGRAMSABOUTISPEWEBINARS
ISPE would like to recognize our newly formed Eurasian Economic Union (Eurasia) Affiliate. The Affiliate provides a local forum through which professionals in Russia, Armenia, Belarus, Kazakhstan, and Kyrgyzstan can contribute to the advancement of the 2021 ISPE ANNUAL MEETING & EXPOSIGN IN - ISPE
Please sign in to continue. Please click on "Forgot Password?" before your 5th attempt to avoid being locked out. If your account is locked out, you must wait 15 minutes before you can attempt to login again. If you need additional assistance, please contact our Member Services Team by email at ask@ispe.org or by phone at (813) 960-2105. An ISPE GUIDANCE DOCUMENTS BY TOPIC An A-Z List of ISPE Guidance Documents by topic. The contents of ISPE’s guidance documents, both printed and digital, are protected by law and intended solely for the personal non-commercial use of the individual purchaser. Reproduction of multiple copies of these materials, in whole or in part, for the purposes of commercial distribution is prohibited. 2021 ISPE FACILITIES OF THE FUTURE CONFERENCE 2021 ISPE Facilities of the Future Conference. The 2021 ISPE Facilities of the Future Conference will explore advancements in pharmaceutical technology and what pharmaceutical manufacturing facilities will look like in the future. Featuring technical and inspirational presentations from industry leaders already planning and building “facilities of the future” this conference will look at PHARMA 4.0 OPERATING MODEL Pharma 4.0 has been called a new industrial evolution. ISPE's SIG has developed an operating model for moving from one industry to another. Digitization and automation meet very complex product portfolios withlong life-cycles.
ISPE EXPERT XCHANGE: ENABLING PHARMA 4.0™ THROUGH PLUG The ISPE Expert Xchange: Enabling Pharma 4.0 will assess opportunities for the digital transformation of bio-pharmaceutical manufacturing. Learn what business outcomes Pharma 4.0™ enables and what architectural and design principles are behind Pharma 4.0.CLEANING VALIDATION
1 May 2021. One of the goals of the cleaning validation design phase is to define critical process parameters (inputs) and acceptance criteria (outputs) of the cleaning process. This article explores the selection of a master soil as part of the cleaning validation designphase for
ADVANCING PHARMACEUTICAL QUALITY, CORRECTIVE ACTION Wednesday, 26 May Time:1100 – 1230 ETIRELAND AFFILIATE
Ireland Affiliate. Ireland Affiliate. ISPE has become a leading organisation and the network of choice for those studying or working within the Life Sciences Sector in Ireland, as it continues to deliver acknowledged value and breakthrough insights to its members. Our next virtual event on May 26th - Current Industry/Regulatory Trends in WFI.ISPE EXPERT XCHANGE
ISPE Expert Xchange is a new interactive, collaborative experience that unites forward-thinking pharma professionals with engaged subject matter experts for immersive, topic-focused events. Benefit from years of unparalleled knowledge as leading authorities in their field through: Small Group Discussions. Technical Presentations. GOOD PRACTICE GUIDES Good Practice Guide: Knowledge Management in Pharmaceutical Industry. ICH Q10 outlines three objectives: achieve product realization, establish and maintain a state of control, and facilitate continual improvement. Embracing these objectives can be best achieved using the dual enablers, Knowledge Management (KM) and Quality Risk Management(QRM).
PHARMA 4.0 OPERATING MODEL Pharma 4.0 has been called a new industrial evolution. ISPE's SIG has developed an operating model for moving from one industry to another. Digitization and automation meet very complex product portfolios withlong life-cycles.
GAMP TRAINING COURSES GAMP 5 GxP Process Control Training Course. This highly interactive, course describes how the GAMP ® Good Practice Guide: A Risk Based Approach to GxP Process Control Systems , may be applied to achieve process control systems that are fit for intended use and meet current regulatory requirements. The course covers recommended good practice based on a life cycle approach for the developmentMIDWEST CHAPTER
The Midwest Chapter came to be because of the need of ISPE members, deep in the heartland and far from the heavy concentration of the pharmaceutical-based industry on the East and West coasts, to network with members of their profession.QUALITY BY DESIGN
Turning Quality by Design (QbD) into a Practical Reality Training Course. Through group exercises, this course on Quality by Design will delve into implementation and operation of an effective and efficientcontrol strategy.
IRELAND AFFILIATE
Ireland Affiliate. Ireland Affiliate. ISPE has become a leading organisation and the network of choice for those studying or working within the Life Sciences Sector in Ireland, as it continues to deliver acknowledged value and breakthrough insights to its members. Our next virtual event on May 26th - Current Industry/Regulatory Trends in WFI. CLEANROOM | ISPE | INTERNATIONAL SOCIETY FOR The commissioning of a cleanroom is a complex and crucial process with many stages that start after the rooms are designed and built. The ultimate goal of cleanroom commissioning is to confirm that the controlled space will have a robust, clean and safe environment for the processing of drug GAMP GUIDE: RECORDS & DATA INTEGRITY The ISPE GAMP® Guide: Records and Data Integrity provides principles and practical guidance on meeting current expectations for the management of GxP regulated records and data, ensuring that they are complete, consistent, secure, accurate, and available throughout their life cycle. This Guide is intended as a stand-alone ISPE GAMP ® GuideITALY AFFILIATE
Italy Affiliate. ISPE Italy Affiliate was founded in Milan in 1992. Currently counts more than 500 members from various sectors of Life Science: manufacturing, engineering e automation, quality assurance, laboratory, logistics, IT, validation, academia and regulatory authorities. Specifically targeted to the needs of facility projectswithin
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Cell & Gene Therapy Facility Design Using SimulationsFeatures
1 November 2020 –
Designing new facilities for cell and gene therapy manufacturing is a challenging task given the many uncertainties in this industry sector, including varying potential demand for any given new therapy, evolving platforms and technology, questions about equipment reliability, learning curves for analysts and operators, possible sourcing issues, and variable lead times for key raw materials. All these factors influence facility sizing, equipment quantities, required head count,and the flow of
FEATURED ARTICLES
Features
Industry Leaders: Focused on the Mission 3 November 2020 Joydeep Ganguly, who is currently Senior Vice President, Corporate Operations, at Gilead Sciences, Inc., places a premium on working for a mission-oriented company. “If you choose the right company with the right ethos and a deep, tangible commitment to the patients, the mission is not just...Features
Vision Inspection Using Machine Learning/Artificial Intelligence 3 November 2020 Pharmaceutical companies rely on automated vision inspection (AVI) systems to help ensure product safety. Although these systems overcome challenges associated with manual inspection, they can be hindered by limitations in their programming—if the system is programmed to consider every variation in...Features
2019 ISPE Europe Biotechnology Conference: Industry Transformations 1 November 2020 As biopharmaceuticals have become a major part of the pharmaceutical industry, we have witnessed significant transformations in product development, strategy, technology, and operations. This ongoing transformational process was the main theme of the fourth annual ISPE Europe Biotechnology...Features
Current State of Oligonucleotide Therapeutics 1 November 2020 Oligonucleotides are a relatively new class of drugs, composed of natural and synthetic nucleotides, which primarily include small interfering RNA (siRNA), micro RNA (miRNA), and antisense oligonucleotide (ASO). These molecules achieve therapeutic effects through RNA interference, degradation, or...Features
Memorable Milestones: 40 Years of ISPE 1 November 2020 ISPE is celebrating its 40th anniversary this year! Here are some of the memorable events from the last 40 years.Features
Flexible Facility Design for Multiple Cell Therapy Processes 1 November 2020 In many critical ways, the design of facilities for multiple cell therapy processes is unlike the design of conventional pharmaceutical facilities. This article surveys several of the key issues to consider when designing facilities capable of manufacturing multiple cell therapies, including...Features
Operational Risk Management in Global Supply Scenarios 1 November 2020 The current regulatory framework in the pharmaceutical industry places pressure on marketing authorization holders (MAHs) to demonstrate quality oversight, and a systematic risk management process is a prerequisite for avoiding compliance and productivity pitfalls. This article focuses on options...Special Reports
2020 ISPE Annual Meeting & Expo: Driving the Future of Pharma 1 September 2020 The 2020 ISPE Annual Meeting & Expo will be ISPE’s first completely virtual Annual Meeting. As always, there will be great learning and networking opportunities—in fact, the digital format offers greater flexibility for attendees.Features
Validation of Clinical Trial–Related Systems in Smaller Enterprises 1 September 2020 Existing risk-based approaches to computerized system compliance and validation as outlined in GAMP® 5International Society for Pharmaceutical Engineering. GAMP® 5 Guide: A Risk-Based Approach to Compliant GxP Computerized Systems. North Bethesda, MD: International Society for Pharmaceutical...Special Reports
FOYA Category Winners & Honorable Mentions for 2020: Examples ofExcellence
1 September 2020 Each year, ISPE celebrates innovations and advances in pharmaceutical manufacturing technology with its Facility of the Year Awards (FOYA) program. This year, we added a new category, Social Impact, to recognize companies that developed new standards and practices to prevent drug shortages and...Features
ISPE France Affiliate: Long-Time Affiliate Continues to Shine 1 September 2020 The ISPE France Affiliate is fortunate in many ways. The pharmaceutical industry in France is world class, employing close to 100,000 people and generating €55.9 billion in annual revenue.LEEM. “French Pharmaceutical Industry—Key Data 2019.” Accessed 9 July 2020.... [Reporting categories for changes in the drug substance (DS) and drug product (DP) process and analytical methods per FDA guidanceFeatures
Case Study: Facilitating Efficient Life-Cycle Management via ICH Q12 1 July 2020 The latest ICH guideline, ICH Q12,International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. “ICH Harmonised Guideline: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. Q12. Final Version.” 20 November 2019....Features
Achieving Vertical & Horizontal Integration in Pharma 4.0™ 1 July 2020 Recent projects on serialization and track and trace help illustrate the concepts of vertical and horizontal integration. With vertical integration, the unique product identification information (serial number, lot, etc.) used by sensors and printers on the packaging lines is made accessible to the...Features
Regulatory Panel Session: Explores Key Aseptic Topics 1 July 2020 The 2020 ISPE Aseptic Conference was capped off on Tuesday, 3 March, by the Interactive Regulatory Panel session, which has been a popular feature of the conference during its 29 years. The session featured a panel of seven US FDA regulators who addressed a long and varied list of questions about...Features
Industry Leaders: Mission-Driven Leadership 1 May 2020 Pam Cheng is Executive Vice President, Global Operations & Information Technology, at AstraZeneca, a United Kingdom–headquartered pharmaceutical company with more than 60,000 employees. In this role, she combines her expertise as an engineer with business savvy and seeks opportunities to lead her...Features
Wearable Devices & Biometrics Improving Efficiency in GxP Operations 1 May 2020 As the old saying goes, “Time is money.” In today’s industrialized world, this adage is profoundly true. Manufacturers can no longer afford to overlook operational excellence. A new production philosophy called “Lean manufacturing” has been developed to save as much time as possible during...Features
Regulators Address Innovations & Harmonization 1 May 2020 At the 2019 ISPE Global Pharmaceutical Regulatory Summit, regulators updated attendees on approaches to industry innovations and the ongoing work on harmonization and reliance around the world.Features
Update from the ISPE Regulatory Steering Council 1 May 2020 Virtually every ISPE member has at least one story to tell about how health authority inspections or the review and approval of regulatory applications have affected their efforts to supply critically needed medications to patients globally. Although these stories may emphasize the considerable...Features
ISPE Comments to the Annex 2 PIC/S Draft Revision 1 May 2020 Annex 2 is the Good Manufacturing Practices (GMP) document by the Pharmaceutical Inspection Co-operation Scheme (PIC/S) addressing manufacture of biological medicinal substances and products for human use. This article shares information about Annex 2 and ISPE’s submitted comments to the draft...Features
A GAMP® Approach to Robotic Process Automation 23 April 2020 This article introduces the concept of robotic process automation (RPA) and discusses how the technology may be used within a GAMP® framework to support both non-GxP and GxP processes.Features
Two Real-World Experiences in Global Sustainability 2 March 2020 The article appraises the real-world experiences of two pharmaceutical companies approaching the rollout of energy- and water-reduction programs to selected facilities around the world. It is the result of more than two years of collaboration between the company corporate teams, individual site...Features
Implementation of a Formal Energy-Efficient Design Process 1 March 2020 Sustainability is a key principle for pharmaceutical companies in 2020. However, translating corporate goals into meaningful improvements can be a challenge, particularly when competing factors such as complex technical requirements or ambitious project schedules are involved.Features
Industry Perspective: Bioremediation of Pharmaceuticals 1 March 2020 Medical treatments and pharmaceuticals are indispensable in improving quality of life. In recent years, however, pharmaceutical compounds have become a significant group of environmental pollutants, shown to pose risks to human health and have adverse environmentaleffects.
Features
Industry Leaders: An Advocate for Quality 1 January 2020 Ranjana B. Pathak, BSc (Hons), MBA, DHA, has spent nearly 40 years in the pharmaceutical industry. Currently the President and Global Head of Quality, Medical Affairs, and Pharmacovigilance at Cipla Ltd. in Mumbai, India, Pathak’s long tenure has afforded her an informed perspective on the past,...Features
Industry Leaders: Bringing Pharma 4.0™ Into the World 1 January 2020 Every important cause needs its champion. Champions have a vision of how things should be, and a passion to reach their goals. They are committed and determined to achieve positive results, are willing to do the heavy lifting, and will take consistent and massive action until results are achieved.View more > >
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White Paper — Sponsored Content How an MES Supports Your Business Continuity 1 November 2020 Business continuity relies on resilience: the ability to successfully deal with crises like COVID-19, to keep manufacturing and supportive business processes alive and to adapt to environmental changes. Pharma and biotech manufacturers who invest in... White Paper — Sponsored Content Addressing the Evolving Information & Automation Needs of Biopharma 1 November 2020 As the biopharmaceutical industry evolves and new opportunities and challenges rise, manufacturers must keep pace. For example, a dramatic increase in the amount of information that is available, in parallel with a reduction in the cost of obtaining,... White Paper — Sponsored Content Mannitol Polymorph Transformation in Continuous Twin-Screw Granulation 1 November 2020 Wet granulation is commonly used in solid formulation to improve powder properties including size, flowability, dissolution rate, bulk density, compressibility and API uniformity. Mannitol has become a preferred filler/binder due to its low...LATEST ARTICLES
iSpeak Blog
Be a Positive Force
18 November 2020 We are constantly being influenced and we ourselves are influencers. As children, we hear the quote that “sticks and stones may break my bones, but words will never hurt me.” What people say and even what people do not say, can have a lasting impact. We are first influenced by our families and some...iSpeak Blog
Regulatory Panel Addresses COVID-19 Challenges 18 November 2020 2020 ISPE Europe Annual Conference At the 2020 ISPE Europe Annual Conference on 16–17 September, which was a virtual conference, three regulatory panel discussions included more than 20 regulators from eight countries and the European Medicines Agency (EMA), Medicines and Healthcare Products...iSpeak Blog
What is the Impact of Article 117 on the Pharma Industry? 16 November 2020 Article 117 of the EU Medical Device Regulation (MDR), fully applying May 26, 2021, is significantly impacting BioPharma companies. While integral drug-device combination products (such as pre-filled syringes and pre-filled injectors) are regulated as medicinal products in Europe (EU), certain...Online Exclusives
Biopharma Facility Design: Lessons Learned on the Dance Floor 13 November 2020 In 2014, Pharmaceutical Engineering® published an article, “Lessons Learned in the Ballroom,”Wolton, D. A., and A. Rayner. “Lessons Learned in the Ballroom.” Pharmaceutical Engineering 34, no. 4 (2014). which presented for the first time an alternative to the then-popular ballroom concept adopted...iSpeak Blog
Read, Learn, Innovate: Top Blog Posts from October 2020 12 November 2020 Featured in this edition of iSpeak Reading Roundup, are the top blog posts from October 2020. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.iSpeak Blog
More Than Just Technology: A Holistic Approach To Pharma 4.0 WebinarQ&A
9 November 2020 What is Pharma 4.0? It is a vision of a holistic company-wide transformation, which balances and combines: productivity, quality, and robustness based on a data-centricperspective.
The Gavel Passes to the New ISPE Board Chair at 2020 ISPE AnnualMeeting & Expo
5 November 2020 The 2020 ISPE Member Meeting included most of the usual components of live Member Meetings: Outgoing ISPE International Board of Directors Chair Frances Zipp passed the gavel to incoming Chair Joanne Barrick, new Board members began their terms, Board members completing their terms departed, and...iSpeak Blog
2020 ISPE Annual Meeting & Expo: How Regulators are Responding toCOVID-19’s Impact
4 November 2020 Global Regulatory Panel Session The COVID-19 pandemic has brought increased harmonization and interaction among regulators around the world and the opportunity to consider changes implemented during the pandemic for the long term. Six regulators from five regulatory agencies discussed these issues...iSpeak Blog
2020 ISPE Annual Meeting & Expo Opening Plenary: New Therapies, NewApproaches
2 November 2020 2020 and the COVID-19 pandemic have presented tremendous challenge to the world and the pharmaceutical industry—but from the pandemic has come stepped up development of vaccines and treatments, increased urgency to address supply chain challenges, and forging ahead to develop and expand of cell and...Technical
Passive Sedimentation Control in Containers Using Marangoni Forces 1 November 2020 When fluid-filled containers are stored for long periods of time with negligible motion, sedimentation and gravitational settling of particles can occur. This article discusses a passive sedimentation control mechanism that is driven by Marangoni stress, which is induced in enclosed geometries when...Technical
Justifying Investment in Manufacturing Execution Systems 1 November 2020 Executives at manufacturing companies of all sizes need to make decisions about where to invest to maintain and grow their businesses. Investments in manufacturing execution system (MES) applications may reduce costs and increase revenues, but they also might compete with other investment...InTouch
ISPE Briefs: ISPE Expands Its Popular Webinar Series 1 November 2020 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.InTouch
ISPE D/A/CH Affiliate: Striving to Lead 1 November 2020 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... Industry Perspective: Validation 4.0 - Shifting Paradigms 1 November 2020 As Pharma 4.0™ increasingly becomes reality, our validation practices must change. We can no longer apply 20th-century thinking to 21st-century technology and resources. Validation must adapt to industry shifts from iterative to disruptive innovation, from batch to continuous processing, from bulk...Insights
Young Professional: From Young Professional to Emerging Leader 1 November 2020 As this is my last Young Professional (YP) column for Pharmaceutical Engineering®, I wanted to start with a quote from Winston Churchill that I feel summarizes my two-year journey as the International Young Professional Chair: “Success is not final, failure is not fatal: it is the courage to...Insights
Women in Pharma® Editorial: A Year of Mentoring, Education, andCollaboration
1 November 2020 2020 has been a super-busy year for ISPE Women in Pharma® (WIP). We started 2020 with aggressive goals, including to set up global Mentor Circles; start a monthly Women in Pharma® newsletter, The Bridge; and begin a column in Pharmaceutical Engineering®. Women in Pharma® has met and exceeded goals...Insights
Message from the Chair: That Was the Year That Was 1 November 2020 Given the events that have transpired over the last 12 months, I have penned the title of my final column as ISPE Chair to reflect the temperament of our times. Coincidentally, and please pardon my digression, the title also happens to be the name of a hit album of topical songs by Tom Lehrer,...iSpeak Blog
24 Hours of Women in Pharma: ‘Speaking Up’ Tips and DiscussionLaunch the Event
30 October 2020 Twenty-four hours of sessions, mentor circles, book clubs and more with ISPE Women in Pharma® (WIP) took place on 27–28 October. The event had almost 160 registrations for the virtual event, which brought together ISPE members around the world for interactive opportunities to learn and exchange...iSpeak Blog
Meet Boehringer Ingelheim and J&J, Janssen Pharmaceuticals, Inc.– 2020 Facility of the Year Honorable Mention Award Winners 29 October 2020 Honorable Mention recognizes projects that did not win a specific category but were clearly successful projects that overcame significant challenges in planning, execution, and delivery.iSpeak Blog
Meet GlaxoSmithKline – 2020 Facility of the Year Award Winner forSocial Impact
28 October 2020 GlaxoSmithKline is the 2020 Facility of the Year Award Winner for Social Impact for their Attachment Inhibitor (AI) Projectin Parma, Italy.
iSpeak Blog
Meet United Therapeutics – 2020 Facility of the Year Award Winnerfor Social Impact
27 October 2020 United Therapeutics is the 2020 Facility of the Year Award Winner for Social Impact for their Dinutuximab-Dedicated Oncology Medical and Analytical Laboratory in Silver Spring, Maryland.iSpeak Blog
Meet Bristol-Myers Squibb – 2020 Facility of the Year Award Winner for Project Execution 26 October 2020 Bristol-Myers Squibb is the 2020 Facility of the Year Award Winner for Project Execution for their Multi-Purpose Cell Culture (MPCC) in Cruiserath, County Dublin, Ireland.iSpeak Blog
Meet Janssen – 2020 Facility of the Year Award Winner for ProcessInnovation
23 October 2020 Janssen Pharmaceuticals is the 2020 Facility of the Year Award Winner for Process Innovation for their Mirror 1: A Continuous Manufacturing Platform in Beerse, Belgium.iSpeak Blog
Meet Eli Lilly and Company – 2020 Facility of the Year Award Winner for Operational Excellence 22 October 2020 Eli Lilly and Company is the 2020 FOYA Category Winner for Operational Excellence for their Lilly Innovation Development Center in Indianapolis, Indiana.iSpeak Blog
The Importance of Confiding in Someone - 24 Hours with the Women inPharma® at ISPE
21 October 2020 There is a real advantage in opening up and confiding in someone. Being vulnerable can be a superpower, but it does not mean that you should trust everyone with everything. It also does not mean that you should always emotionally charged break downs....View more > >
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HVAC and Cleanroom Design: ZETA is Expanding its Service Portfolio 1 November 2020 The highest quality and safety standards are key criteria in the planning and development of production facilities for pharmaceutical and biotech companies. However, building services engineering is no less important and demands in this field have been increasing steadily over the past few years....CURRENT ISSUE
NOVEMBER / DECEMBER 2020 Cell and Gene Therapy Facility Design Using Simulations Cover: Designing new facilities for cell and gene therapy manufacturing is a challenging task given the many uncertainties in this industry sector. One approach to managing these uncertainties at the facility design stage is to develop operational models and perform computer simulations. The information generated via these simulationsenables...
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