iSpeak Blog

March 23, 2018
As part of the planning committee, I’m very pleased to share this year’s theme for the 2018 ISPE Quality Manufacturing Conference, June 4-6 in Arlington, VA: Manufacturing and Quality: Present and Future Opportunities to Ensure Continuous Improvement...
March 22, 2018
Getting your feet wet with continuous technology takes an organizational commitment, both financial and personnel. This is because continuous is a manufacturing approach, not a hardware solution. Continuous manufacturing relies on multiple interactin...
March 21, 2018
This article was originally published in the May-June 2017 issue of Pharmaceutical Engineering® magazine . Catch up on this series by reading: Corrosion Investigation of Pharmaceutical Clean Steam Systems - Part 1 Corrosion Investigation of Pharmaceu...
March 15, 2018
As we start to populate and organize the education sessions for the 2018 ISPE Annual Meeting & Expo , I think back to my experiences at the 2017 ISPE Annual Meeting & Expo . We had exposure to global regulators and were able to hear about news and th...
March 14, 2018
This article was originally published in the May-June 2017 issue of Pharmaceutical Engineering® magazine . Catch up on this series by reading: Corrosion Investigation of Pharmaceutical Clean Steam Systems - Part 1 Corrosion Investigation of Pharmaceu...
March 13, 2018
This article was originally published in the January-February 2018 issue of Pharmaceutical Engineering® magazine . Read the entire series: Bowtie Analysis and Barrier-Based Risk Management – Part 2 Bowtie Analysis and Barrier-Based Risk Management –...
March 12, 2018
The other speakers and I were pleased so many attendees had chosen our session. Even this exceptionally large room seemed full. Perhaps it was the clever session headline; “Caging the Tiger: Managing the Risk of Contamination”, or the challenge impli...
March 09, 2018
In addition to strong Regulatory participation (FDA and international) in keynote and track break-out sessions, the planning committee for the 2018 ISPE Quality Manufacturing Conference is putting together some of the best technical quality manufactu...
March 08, 2018
Thursday, March 8th is International Women’s Day and as described on the United Nations website: ”It is a day when women are recognized for their achievements without regard to divisions, whether national, ethnic, linguistic, cultural, economic or po...
March 07, 2018
This article was originally published in the May-June 2017 issue of Pharmaceutical Engineering® magazine . Read the entire series: Corrosion Investigation of Pharmaceutical Clean Steam Systems - Part 2 Corrosion Investigation of Pharmaceutical Clean...