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With so many interactive sessions and networking opportunities, you’re probably still trying to finalize your itinerary for the 2016 ISPE/FDA/PQRI Quality Manufacturing Conference. While you’re doing that, make sure to pencil in time to explore the...
iSpeak Blog
We’re just days away from the kick-off of the most important regulatory event of the year –  the 2016 ISPE/FDA/PQRI Quality Manufacturing Conference. The program committee worked hard to develop a comprehensive program to help you navigate the...
iSpeak Blog
Getting Ready to Grow: Delivering on Our Promise to Patients We are excited to invite you to ISPE's inaugural Biopharmaceutical Manufacturing Conference from 5 – 7 December in San Francisco, California. Join us as we bring together experts and leaders...
iSpeak Blog
Design Considerations for Water for Injection (WFI) Distillation Systems for Improving Quality, Project Performance, and Equipment Life Cycle Cost Reduction was featured in the September/October 2015 issue of Pharmaceutical Engineering® magazine. This...
iSpeak Blog
I worked in other industries earlier in my career but when I made my connection to medicine (biotechnology, pharmaceuticals, and medical devices), I quickly recognized our industry’s impact on improving and extending lives, which gave me an enormous...
iSpeak Blog
Pharmaceutical manufacturing professionals from around the world will soon be able to choose between three locations for professional training and skills development. St. Gallen, Switzerland, and Dublin, Ireland, have joined Tampa, Florida, as...
iSpeak Blog
How do we incorporate the new technologies of Single-Use and Continuous Processing? What can be done to make factories more flexible and efficient? What types of new features can be expected in devices and what challenges may occur? The 2016 ISPE...
iSpeak Blog
Receive first-hand information from global regulators and gain invaluable insight to assist your company in navigating the increasingly complex nature of regulatory compliance and quality expectations at the 2016 ISPE/FDA/PQRI Quality Manufacturing...
iSpeak Blog
The summary below has been collated from various commentaries on the subject of Brexit and the potential implications for the pharmaceutical industry. References to the original articles are captured in the Reference Section. On 23rd June 2016, United...
iSpeak Blog
Set the Standard for Innovation in Pharmaceutical Facilities The 2017 Facility of the Year program (FOYA) recognizes projects that exemplify global leadership by showcasing innovative engineering, cutting-edge new technology, or advanced applications...
iSpeak Blog
Design Considerations for Water for Injection (WFI) Distillation Systems for Improving Quality, Project Performance, and Equipment Life Cycle Cost Reduction was featured in the September/October 2015 issue of Pharmaceutical Engineering® magazine. This...
iSpeak Blog
Data integrity and its definition in the context of pharmaceutical manufacturing has been the subject of a lot of discussion in recent years. Manufacturing processes are highly complex, and every step generates data that must be recorded and reviewed,...
iSpeak Blog
A number of firms have been cited for GxP records in their disposal bins(1-3).  It is easy to read these observations and conclude they do not apply to your firm – but are you sure?  You might have instructed personnel that they must never place a...
iSpeak Blog
Malik Belattar, chair of the ISPE Disposables Steering Committee and Pharma Biot’Expert’s representative, invites you to join the discussion about several important topics related to disposables. The ISPE Communities of Practice (CoP) has highlighted...
iSpeak Blog
The word “sustainability” has been surrounding us for many years now.  Standards such as the LEED Green Building System (LEED) or Energy Star have become not only a marketing edge, but an expectation. Although these standards address some aspects of...
iSpeak Blog
It’s time for another edition of the Reading Roundup featuring the top blog posts from April 2016.  Grab your favorite cup of coffee, kick back and catch-up on what the pharmaceutical industry was reading in April. OSD Gowning Procedures Knowledge...