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Please join me at the 2019 ISPE Global Pharmaceutical Regulatory Summit, being held at the Bethesda North Marriott in Bethesda, Maryland December 5-6, 2019. The theme for this year’s summit is “Igniting Innovation in Development & Quality During...

Edwin L. Harmon, III Vice President of Engineering, Facilities and Validation LSNE - Contract Manufacturing Organization Edwin Harmon, Vice President of...

Design and construction of facilities and equipment using modern day information technology is common in today’s project execution. Comprehensive 3D modelling, component databases, scheduling and planning are all common place, almost to the point that...

ISPE sat down with Carmelo Rosa, PsyD, Director, Division of Drug Quality and Senior Officer of Compliance, FDA/CDER, and co-chair of the 2019 ISPE South Asia Pharmaceutical Manufacturing Conference to discuss key event highlights and takeaways The...

The Asia Pacific (APAC) region is diverse in terms of its demographics. From the developed countries such as Japan, South Korea, Taiwan, Singapore, and Australia to emerging economy countries such as Thailand, Indonesia, Malaysia, Vietnam, Bangladesh,...

Kantonsapotheke Zürich (KAZ) is the 2019 Facility of the Year Operational Excellence Category Winner for their New Compounding Pharmacy for Canton Zurich Hospitals project in Schlieren, Switzerland.

The needs of patients provide the impetus to challenge the notion of “this is the way we’ve always done it”.

Extremely Competent. Hardworking. Strong Leadership Skills. Results Oriented. Proven Track Record. Are these qualities all that it takes to progress your career? Perhaps something more is needed? Having a sponsor can make all the difference – and propel...

Aseptic processing of parenterals is one of the most challenging tasks within pharmaceutical manufacturing. Join us along with federal and state regulators at the 2019 ISPE South Asia Pharmaceutical Manufacturing Conference on 25 – 27 September, at the...

Pharmaceutical manufacturing sites that export their products around the world are often subjected to many GMP inspections each year by different regulatory authorities, with a significant number of these being duplicate, same-scope inspections. This is...

Moderna, Inc. is the 2019 Facility of the Year Category Winner for Facility of the Future for their New cGMP Clinical Manufacturing Facility in Norwood, MA.

Asia Pacific Pharma Outlook The healthcare market in the Asia Pacific (APAC) region is continuing to grow at a steady rate with an estimated 500-billion-dollar industry by 2020. This is due to rising development in smart manufacturing and government...

Featured in this edition of iSpeak Reading Roundup, are the top blog posts from July 2019. See trending ideas for regulatory compliance, biopharmaceutical innovation, and more for what the pharmaceutical industry was reading last month. Integrated...

The 2019 ISPE Asia Pacific Pharmaceutical Manufacturing Conference will be held 30 September to 1 October in Singapore. The conference is modelled on the regional ISPE conferences held in North America and Europe each year and follows a successful pilot...

A fundamental flaw in the way the industry develops manufacturing processes could be the reason.

We are three months out from the 2019 ISPE Annual Meeting & Expo and we have finalized the titles and session topics for the Quality Systems and Regulatory Track. As director of this education track, I can tell you that the program is looking...

How CMOs keep conditions controlled and reduce costs with temporary power, climate control, 100% oil-free air

Pfizer Inc. is the 2019 ISPE Facility of the Year Category Winner for Facility Integration for their Pfizer Global Technology Center in Hangzhou, China.