iSpeak Blog
Where does the time go?  It’s been fourteen months and it seems just like yesterday you elected me Chair of the ISPE International Board of Directors.  In just a few short weeks I will transfer Chairmanship to Chair-elect Tim Howard at the 2017 ISPE...
iSpeak Blog
FDA wants us to instill a strong quality culture in our operations.  To track our progress toward that strong quality culture we have been asked to measure quality parameters.  Those metrics are presumed to reflect the underlying quality culture of an...
iSpeak Blog
It’s time for another edition of Reading Roundup featuring the top blog posts of September 2017. Start off your week by catching up on what the pharmaceutical industry was reading in September. 5 Key Steps in the Calibration Optimization Journey John...
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This year’s ISPE Annual Meeting & Expo will be full of great, thought-provoking content for the Investigational Products Community of Practice. The theme “Driving Innovation to Advance Patient Therapies” aligns with the Investigational Products track...
iSpeak Blog
Participants gathered for the Women in Pharma breakfast on day 2 of the 2017 ISPE/FDA/PQRI Quality Manufacturing Conference, held June 5–7, 2017. Women in Pharma Chair, Fran Zipp, President and CEO, Lachman Consultants and ISPE Board member, welcomed the...
iSpeak Blog
  Involved in the biotechnology industry now or want to be in the future? You should register for the ISPE 2017 Annual Meeting & Expo. This year’s event takes place in sunny San Diego, California from 29 October through 1 November.   Sessions will...
iSpeak Blog
Wided Najahi-Missaoui Granted First Women in Pharma Scholarship Wided Najahi Missaoui, MS PharmDThe Women in Pharma (WIP) Networking Community launched its first education series at the ISPE 2016 Annual Meeting & Expo. Thank you Fran Zipp and Charlotte...
iSpeak Blog
In 1997, I landed my first post-graduate job which just happened to involve designing and testing process control systems for use in pharmaceutical manufacturing (my career plan at that time focused on getting a job—what for was irrelevant after four...
iSpeak Blog
It’s time for another edition of Reading Roundup featuring the top blog posts of August 2017. Start off your week by catching up on what the pharmaceutical industry was reading in August. Performance and Validation of Ozone Generation for Pharmaceutical...
iSpeak Blog
ISPE is proud to announce launch of our new website! Our goal with this redesign was to provide our Members and potential Members with an interactive, fluid means to access all that ISPE has to offer—from regulatory resources, trending pharma news,...
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Wided Najahi-Missaoui, MS, PharmDWided Najahi-Missaoui, MS, PharmD, doesn’t know the meaning of the word "can't." Since arriving in the United States from Tunisia in 2000, she has earned two graduate degrees (a close friend says she collects degrees like...
iSpeak Blog
Conference Essentials Process Validation Conference: Explore the Conference Program Travel Tips Hotel Dining Options Process Validation Statistics Conference: Explore the Conference Program Travel Tips Hotel Dining Options Registration...
iSpeak Blog
The ISPE 2017 Annual Meeting & Expo is fast approaching! As our Chairman, Mike Arnold expressed in his 11 July 2017 Chairman’s Chatter, “This event showcases the latest, successfully employed strategies and technologies that meet today’s growing...
iSpeak Blog
With over 13 years’ experience in the pharmaceutical and bio-pharmaceutical industry, John works with clients in both Ireland & the US to help them achieve a state of Calibration & Maintenance Program Excellence Here John talks us through the 5 Key...
iSpeak Blog
Why is water so crucial to the pharmaceutical industry? Water is required for production of all pharmaceutical products and can be the most expensive ingredient in some applications due to the large volumes required for production and cleaning. Water...
iSpeak Blog
As members of ISPE, we are fortunate to have leaders who had the foresight to sponsor Quality Metrics Pilot programs which continue to provide a rich framework for objective data-driven discussions. One such discussion took place on 1 August 2017 when a...
iSpeak Blog
1. Why is cleaning and cleaning validation so crucial to the pharmaceutical industry? Cleaning and cleaning validation are of crucial importance to patient safety. Only by ensuring that our process equipment is clean through a reproducible process can...
iSpeak Blog
Participants gathered for the Women in Pharma breakfast on day 2 of the 2017 ISPE/FDA/PQRI Quality Manufacturing Conference, held 5 – 7 June. Women in Pharma Chair, Fran Zipp, CEO and President, Lachman Consultants and ISPE Board member, welcomed the...