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January 28, 2021
ISPE Gathers Global Aseptic Leaders to Discuss Trends, Innovations, and COVID-19 Impact Share Article ISPE announced its 2021 ISPE Aseptic Conference, taking place virtually on 15–17 March 2021. Now in its 30th year, this signature event has established itself as the pharmaceutical industrys leading source on advancing aseptic and barrier operations and providing invaluable opportunities for peer-to-peer learning through interactions with industry and regulatory leaders. Sterile dosage forms ...
January 21, 2021
ISPE Publishes ISPE Good Practice Guide: Equipment Reliability Share Article This Guide offers best practices with respect to equipment reliability, addresses specific opportunities for the pharmaceutical industry beyond the general reliability of equipment, and can serve as the basis for an effective reliability program. As innovation extends to and transforms the supply chain, equipment lifecycle costs and availability become ever more relevant to maintaining a competitive advantage. ...
January 12, 2021
Brijesh Patel appointed Director of Consulting for Azzur Worcester With more than a decade of experience in GxP compliance, commissioning, validation and quality assurance, Brijesh Patel joins the Azzur Group team to support continued growth in the Central New England Region. News provided by Share this article WORCESTER, Mass., Jan. 12, 2021 /PRNewswire/ -- Azzur Group is pleased to announce the appointment of Brijesh Patel to the Director of Consulting for Azzur Worcester. Founded in 2020,...
January 1, 2021
Published: Jan 01, 2021 By Alex Keown ImmunityBio – Fabio M. Benedetti was named chief strategy officer of California-based ImmunityBio. Benedetti will oversee life-cycle management, pipeline and commercial strategy, including medical affairs. Following the completion of ImmunityBio’s proposed merger with NantKwest, Benedetti is expected to assume the role of chief strategy officer of the combined company. Benedetti most recently served as chief medical officer for Apollomics, Inc....
December 18, 2020
10th December 2020 Article by Huai Nyin (Grace) Yow AMIChemE, Steve Marshall, Scott Davies, Sonia Ganatra and John Hancock CEng FIChemE Huai Nyin (Grace) Yow and colleagues discuss the engineering challenges specific to pharmaceutical projects I S engineering a pharmaceutical project more challenging than for other industries? An engineering project, generally, has a defined development path: conception; design (P&IDs, design calculations, equipment selection, 3D-model and software writing);...
December 17, 2020
ISPE Invited to Participate in DAF ACT Initiative to Support Domestic Manufacturing of Active Pharmaceutical Ingredients Share Article ISPE announced their participation in the Department of the Air Force Acquisition COVID-19 Task Force (DAF ACT) to advise Regulatory, Technical, and Workforce elements favorable to creating a more robust and sustainable domestic pharmaceutical manufacturing base for Active Pharmaceutical Ingredients (APIs). This partnership aligns with ISPE’s mission to suppor...
December 15, 2020
ISPE Publishes ISPE APQ Guide: Corrective Action and Preventive Action (CAPA) System Share Article This is the first in the planned four-part series that seeks to improve the state of pharmaceutical quality and ensure sustainable compliance. The Guide Series is part of ISPE’s newest initiative, Advancing Pharmaceutical Quality (APQ), a comprehensive program for assessing and improving an organization’s quality management maturity. The APQ Program recognizes that the ability to advance the m...