ISPE

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Educational Sessions/Workshops highlight ISPE conference.

Taking place February 21-24, 2011 Tampa Conference will feature 8 educational sessions, including one on FDA inspection enforcement trends. Other sessions will focus on issues such as aseptic processing of sterile products; Quality Risk Management (QRM); and data integrity verification, validation, and maintenance. Other sessions address inspection readiness, syringe processing, containment for...

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Association News

ISPE Releases ISPE Good Practice Guide: HVAC & Process Equipment Air Filters

BETHESDA, MD. (PRWEB) FEBRUARY 04, 2020 - The International Society for Pharmaceutical Engineering (ISPE) announced the release of its latest guide, ISPE Good Practice Guide: HVAC & Process Equipment Air Filters. This Guide provides readers with a better understanding of current technologies and their application as it relates to current regulations and regulatory guidance, as well as the...

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Association News

ISPE to release preliminary data from Quality Metrics Pilot.

ISPE, in conjunction with McKinsey & Co., will release preliminary data and findings from its Quality Metrics Pilot Program at ISPE Quality Metrics Summit, April 21–22. Pilot data and findings will provide insight on what may be collected, how it may impact how pharmaceutical companies are regulated, and how quality might be measured. During summit, participants will hear case studies from some...

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Association News

Pharma EXPO clues audience in on packaging innovation advances.

Pharma EXPO, to be co-located with PACK EXPO International (November 2–5, 2014 inÂ- McCormick Place, Chicago, IL), will serve as resource for innovations in marking, coding, and package printing. As joint venture of PMMI, Association for Packaging and Processing Technologies, and ISPE, show will help pharmaceutical manufacturers discover solutions needed to increase printing speeds...

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Association News

Biotechnologists will uncover innovation at Pharma EXPO.

Co-located withÂ- PACK EXPO International, Nov 2–5, 2014, Pharma EXPO is a joint venture of PMMI, The Association for Packaging and Processing Technologies, and ISPE. Show will connect biotechnology professionals with solutions to meet needs of complex operations requiring flexible manufacturing and adaptable process technologies. Some highlights will include Next Generation bioreactor...

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Association News

ISPE announces launch of Metrics Pilot Program.

ISPE has announced official launch of its Metrics Pilot Program, which is headed by ISPE’s PQLI® Quality Metrics Team, and is now open to any drug manufacturing company that is registered with FDA. Primary objectives are to test harmonization of definitions for industry consensus metrics that represent both leading and lagging indicators, and to test feasibility of data collection across...

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Association News

ISPE to develop Drug Shortages Prevention Plan. .

ISPE announced that it will work with stakeholders to produce Drug Shortages Prevention Plan to guide the pharmaceutical and biopharmaceutical industry in establishing reliable and resilient supply chains that provide quality medicines to patients without interruption. Plan will address optimal organizational strategies, such as aligned governance and communication practices, effective...

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Association News

Annual Tech Conference to draw 1,000 life science professionals.

Life science professionals attending ISPE-CaSA Life Sciences Technology Conference on April 8, 2014 in Raleigh, NCÂ- will learn latest manufacturing techniques through demonstrations and informational sessions. Attendees can also partake in educational seminars by industry subject matter experts, gain insight from industry professionals on real-life manufacturing issues, and view innovations...

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Association News

Pharm EXPO offers smart solutions for lifecycle innovation.

Co-located with PACK EXPO International, and produced in partnership by PACK EXPO owner and producer PMMI and ISPE, debut edition of Pharma EXPO will bring over 200 exhibitors and 10,000 attendees together Nov 2–5, 2014. Educational sessions will cover critical topics such as anti-counterfeiting, international regulatory issues, automation trends, cold chain, nutraceuticals, contract packaging,...

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Association News

ISPE confirms keynote speakers for ISPE Aseptic Conference.

Thomas Arista, Investigator/National Expert-Biotech, FDA/ORA/ORO/DDFI, and Richard Friedman, Associate Director, Office of Manufacturing & Product Quality, FDA/CDER/OMPQ have been confirmed as keynote speakers at ISPE’s 23rd Annual Conference on Barrier Isolation, RABS and Aseptic Processing Technology. ConferenceÂ- will also feature top aseptic processing experts from FDA, Merck, Merck...

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Association News

Two ISPE Studies were cited in FDA statement to Congress.

In her statement associated with her testimony to U.S. Congressional Committee on Oversight and Government Reform's Subcommittee on Energy Policy, Health Care, and Entitlements, Janet Woodcock cited 2 ISPE studiesÂ- – survey conducted by ISPE UK Affiliate's Process Analytical Technology (PAT) Community of Practice, and Drug Shortages Survey report – to advocate use of Quality by Design...

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