Predictive Maintenance Technologies

June 5, 2018 ||
Predictive Maintenance (PdM) technologies are not just for use after your equipment has been installed.  Many of these technologies can be applied during the various stages of your commissioning activities.

Commissioning Teamwork

May 29, 2018 ||
How to best develop good teamwork across the General Contractor, subconsultants, CxA, and Operations during a project.

E-Pub: The Importance of Annex 1

May 21, 2018 ||
Annex 1 – “Manufacture of Sterile Medicinal Products.” was first published in 1971. However, the first revision since then is currently in process. And this revision will have impact way beyond the EU borders. World Health Organisation (WHO-all United Nations are members) and Pharmaceutical Inspection Co-operation Scheme (PICs) are actively…

Moving the Goalposts?

April 5, 2018 ||
Can a standard Corporate Scoring Framework be applied across the spectrum of Quality Risk Management?

In Review: Facilities of the Future Conference

February 27, 2018 ||
ISPE held its second Facilities of the Future conference.  The conference brought together over 160 professionals from pharmaceutical and biotech manufacturing, equipment suppliers, academics, and regulators.  Jim Breen, Vice President Lead Biologics Expansion, Janssen Pharmaceuticals, was the Program Planning Chair.