ISPE announced its 2018 Quality Manufacturing Conference, taking place 4 – 6 June in Arlington, Virginia USA. Broad regulatory involvement throughout this signature conference makes it the ideal setting for pharmaceutical professionals to gain a...
ISPE announced the speaker line-up for their 2018 Continuous Manufacturing Workshop, taking place in 6–7 June in Arlington, Virginia USA, in conjunction with their 2018 Pharmaceutical Manufacturing Quality Week.
New Format for Stronger Interaction
Fifth Annual ISPE/FDA/PQRI Quality Manufacturing Conference
John Bournas, ISPE CEO and President, welcomed attendees to the fifth annual ISPE/FDA/PQRI Quality Manufacturing Conference, themed “Align Your Company...
Tired of going to a conference and listening to talk about talk? Want your voice to be heard?
Expect a brand new experience at 2017 ISPE/FDA/PQRI Quality Manufacturing Conference!
The 2017 Quality Manufacturing Conference offers a new and exciting...
Proactive Approaches to Facility and Life Cycle Quality Management Workshop
Jim McGlade, Science Client Leader for BHDP Architecture, led the “Proactive Approaches to Facility and Lifecycle Quality Management” Workshop. “What’s an architect doing in...
Know Before You Go!
Conference Essentials
Explore the Conference Program Travel Tips Hotel Dining Options Registration and Information Hours Monday, 5 June 2017 | 07.00 – 17.30 Tuesday, 6 June 2017 | 07.00 – 19.30 Wednesday, 7 June 2017 | 07.00 –...
Clinically Relevant Specifications (CRS) are a set of criteria and acceptance ranges—such as impurities, dissolution, and in vitro release testing—to which drug products should conform to deliver their therapeutic benefits. Questions remain on...
Round Table Provided Open Conversation with FDA Regulators
Disclaimer: This is an abridged, unofficial summary of an FDA panel Q&A that has not been vetted by the agency. The responses below are an informal synopsis of the regulators’ views. These...
The New Quality Paradigm
François Sallans, Vice President, Quality and Compliance, and Chief Quality Officer at Johnson & Johnson, and the Honorary Industry Chair for the 2017 ISPE/FDA/PQRI Quality Manufacturing Conference, introduced the day’s first...
Within the pharmaceutical industry quality is more than a competitive advantage; it is our commitment to those who rely upon our products. The degree to which quality is embedded in an organization’s culture can make the difference in meeting that...