On Sunday I will have the pleasure of facilitating a spotlight session on “The Women in Pharma” at the ISPE Annual Meeting in San Diego, California. We will be meeting from 1415 – 1515 to participate in round table discussions focusing on ourselves. We will cover topics on leadership, higher…
“…there are five dominant management systems required to achieve manufacturing performance…. Each element drives an important priority within the organization. An imbalance in any direction will create a gap and introduce unnecessary organization variation, impacting product quality.”
The Failure Modes and Effects Analysis (FMEA) is a versatile risk management tool that has been around for several decades, first used by the US Armed Forces in 1949. It started gaining popularity in the 1960’s with its use in the aerospace industry during the Apollo missions. FMEA has been…
As responsible Project Managers, we need to deliver maximum benefits realization to our project stakeholders on each project. The key to maximum benefits realization is clearly delineating stakeholder requirements and assuring these requirements are satisfied throughout the project lifecycle. A critical component for assuring stakeholder requirements are satisfied is following…
The ISPE Good Practice Guide on Records and Data Integrity defines a data life cycle consisting of: Creation — Processing — Review, Reporting, and Use — Retention and Retrieval — Destruction A robust data integrity program ensures data integrity across this entire life cycle. Such a program would include a risk-based analysis of all data flows to identify,…
NASA recently ended a 20 year 5-Billion-mile space journey as its Cassini space probe burned up in Saturn’s atmosphere (NASA.gov Cassini Mission Site). This $3.26 billion joint venture with ESA (the European Space Agency) opened our eyes to the ringed planet. Completing the mission was no small feat, and the…
Introduction: One of the major focuses this year at the RAPs Convergence in DC was implementation timelines for the EU Medical Device Directive and the In Vitro Device Regulations.
“The ultimate goal of providing a robust, safe method to transfer solutions in the Manufacturing Facility was achieved and CAI played a major role with this safety initiative.”
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