iSpeak

iSpeak Blog
One of the most significant changes to the pharmaceutical industry in the last decade has been the increased speed in developing new therapies. A striking example of this is the rapid rollout of the COVID-19 vaccines. What usually took 10-15 years was researched, developed, and put into production...
iSpeak Blog
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). The pharmaceutical...
iSpeak Blog
Pharmaceutical Engineering® magazine is proud to announce the 2020 Roger F. Sherwood Article of the Year is “Implementation of a Formal Energy-Efficient Design Process” (Mar-Apr) by Aoife Hamill, BE MSc, John Hanley, PhD, MPhil, CEng, and Vincent Lane.
iSpeak Blog
The strength of ISPE’s global network of Affiliates and Chapters is critically important in achieving ISPE’s mission to be the global industry leader in connecting pharmaceutical knowledge to deliver manufacturing and supply chain innovation, operational excellence, and regulatory insights to...
iSpeak Blog
Apply for an ISPE grant to attend the 2021 ISPE Annual Meeting & Expo and a one-year ISPE Membership. If you have less than five years of experience in the pharmaceutical or life sciences industry, you could be eligible to receive a grant to attend the 2021 Annual Meeting & Expo in Boston,...
iSpeak Blog
Pharmaceutical Engineering® is delighted to announce the finalists for the 2020 Roger F. Sherwood Article of the Year Award. The articles were selected by the judges from 35 feature and technical articles published in PE during calendar year 2020 (Volume 40).
iSpeak Blog
Introduction The U.S. Food and Drug Administration (FDA) has announced the reorganization of the agency’s information technology (IT), data management and cybersecurity functions into the new Office of Digital Transformation (ODT). This is a significant step in the FDA’s technology and data...
iSpeak Blog
This week ISPE released The ISPE GAMP® Good Practice Guide: Enabling Innovation – Critical Thinking, Agile, IT Service Management. The first such guidance to discuss critical thinking, agile and IT service management in relation to the life sciences industry, the Guide seeks to apply ISPE GAMP® 5...
iSpeak Blog
Pharmaceutical Engineering® magazine is proud to announce the 2019 Roger F. Sherwood Article of the Year is “Regulating Online Pharmacies and Medicinal Product E-Commerce” (Nov-Dec 2019) by Sia Chong Hock, Mervyn Ming Xuan Lee, and Lai Wah Chan.
iSpeak Blog
The needs of patients must always be at the forefront of what we do. Many of our colleagues are taking on the challenge of rethinking the old ways. They are collaborating with each other and the regulatory agencies to take effective steps to remain at the forefront of regulatory science and...
iSpeak Blog
The San Francisco Bay Area Chapter has won numerous ISPE Awards by virtue of their contributions to the pharmaceutical industry. They continue to have their finger on the pulse of the local industry and respond with innovative and educational programs. The Chapter’s Emerging Leaders Committee is...
Subscribe to ISPE ISpeak Articles