Articles

Featured in this edition of iSpeak Reading Roundup, are the top blog posts from November 2019. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last...

The formal announcement and certification of the ISPE Mexico Affiliate took place at the recent 2019 ISPE Annual Meeting & Expo in Las Vegas, Nevada on Tuesday, October 29. The creation of the ISPE Mexico Affiliate was promoted by a group of enthusiastic...

On Wednesday, 4 December 2019, ISPE held its first-ever Executive Forum focused on Workforce of the Future issues impacting the pharmaceutical industry.  The Forum was an important milestone in the broader Workforce of the Future initiative being led by...

Recap of the Opening Plenary Session of the 2019 ISPE Global Pharmaceutical Regulatory Summit Industry and regulators came together on 5-6 December for the 2019 ISPE Global Pharmaceutical Regulatory Summit in North Bethesda, Md. Regulators were both...

The inaugural Global ISPE Student & Young Professionals’ Hackathon at 2019 ISPE Annual Meeting & Expo brought together 36 students and Young Professionals from around the world to compete in a team-oriented, highly educational workshop. The Hackathon...

Philippe Fournet-Fayard Vice-President ISPE Mexico Affiliate The newly established ISPE Affiliate in Mexico is led by a group of 14 professionals, with...

Costs of pharmaceuticals to the American consumer and healthcare systems are immense, so immense in fact that Senators are calling for new actions to address the high cost of prescription drugs in America. The US spent 345 billion USD on prescription...

Kantonsapotheke Zürich (KAZ) was honored as the 2019 Facility of the Year Awards (FOYA) Overall Winner during the member breakfast at the 2019 ISPE Annual Meeting & Expo in Las Vegas, Nevada, on Tuesday, 29 October. Recognizing the project for showing,...

Featured in this edition of iSpeak Reading Roundup, are the top blog posts from October 2019. See leading facilities, break-through therapies, innovative technologies, and more for what the pharmaceutical industry was reading in October. Benefits of...

Raise your hand if you often speak before you think. If this is you (as it’s often me), I encourage you to slow down and consider your words carefully. What we say in conversation and presentation speaks volumes about our level of confidence and how we...

The Aseptic Processing is facing the next generation of pharmaceutical products and GMP requirements. The Annex 1 draft is in the final stage and we expect the publication before the next ISPE Aseptic Conference in North Bethesda, MD. The Annex2/PICs...

Background As part of the Case for Quality program US FDA CDRH (Center for Devices and Radiological Health) have identified that an excessive focus on compliance rather than quality may divert resources and management attention towards meeting...

The pharmaceutical industry’s ability to evolve alongside innovations in technology and science increases with the incorporation of digital systems and redesigned data collectors. Pharma 4.0™ is a trending industry initiative that highlights the impact...

Jennifer Lauria Clark, CPIP Executive Director, Strategic Development CAI Jennifer Lauria Clark joined ISPE as a college student, and since then, has...

ISPE 2019 Global Pharmaceutical Regulatory Summit is entitled: Igniting Innovation in Development & Quality During Lifecycle Management I think we would all agree that these are exciting times for the pharmaceutical industry. There is a revolution in...

Day 3 Recap: 2019 ISPE Annual Meeting & Expo The Membership and Awards Breakfast on Tuesday 29 October at the 2019 ISPE Annual Meeting & Expo saw a number of ISPE members honored with awards, a report on the state of the Society, and new ISPE...

This morning I passed the gavel and ended my time as Chairman of the International Society of Pharmaceutical Engineering (ISPE) Board of Directors. ISPE is a GREAT professional society that represents 18,500+ Members around the world in 65+ countries,...

Day 2 Recap: 2019 ISPE Annual Meeting & Expo  The second day of the 2019 ISPE Annual Meeting & Expo kicked off with a fireside chat with a key FDA official about technology and related issues, and two presentations about the industry’s move forward to...

Day One Recap of the 2019 ISPE Annual Meeting & Expo Change is a constant in the pharmaceutical industry. Improving the ways in which the industry changes can help develop and deliver therapies to patients. Speakers at the Opening Plenary of the 2019...

The winner of the 2018 Roger F. Sherwood Article of the Year award is Continuous Manufacturing in Biotech Processes: Challenges for Implementation by Robert Dream, PE, CPIP; Christoph Herwig, PhD; and Emilie Pelletier. The article explores the promise...

Pharmaceutical companies deal with challenges and unexpected issues that touch every aspect of the business. While tending to the demands of stringent compliance requirements and production schedules, other priorities such as improving process stability,...