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During 2020, the pressure points of the COVID-19 pandemic challenged us to broaden our thinking and change our practices. Adjustments were made at a global scale and more people were immersed in the experience of dealing with a crisis than ever before. This generated a spotlight on pharmaceutical...

At the ISPE Singapore Affiliate’s 20th Anniversary Conference on 9-12 December 2020, four international regulators discussed how regulatory authorities and industry were responding to the COVID-19 pandemic crisis.

Featured in this edition of iSpeak Reading Roundup, are the top blog posts from January 2021. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.

The New ISPE Discussion Paper, “Unique Identification on Primary Containers to Drive Product Traceability & Quality” explores how container traceability in parenteral manufacturing can drive patient safety, production efficiency, and quality.

Over more than two decades, the pharmaceutical industry has increasingly adopted single-use technologies primarily to simplify manufacturing while hoping to reduce cost; however, the need to reduce environmental burden continues to have a huge impact on these operations. As a member of the 2021...

Teresa Minero has served as ISPE Italy Affiliate Chair, Vice-Chair, and as a leader of the Affiliate’s Student and Women-in-Pharma Groups. An ISPE Member for more than 26 years, she is currently a member of the ISPE Board of Directors. The Founder and CEO of her own company, LifeBee, Teresa has...

What is accountability? By definition, “it is taking or being assigned responsibilities for something that you have done or something that you are supposed to do.” We can take this far beyond that. Accountability means doing what we say we will do, always, on time and to the best of our ability. It...

The 2021 ISPE Aseptic Conference is your key to unlocking success – success in personal technical growth, success in a robust project execution, and success for continuous operation and improvement. I have said for years that the ISPE Aseptic Conference is the best technical conference and has...

The ISPE APQ Assess, Aspire, Act and Advance Framework will be complemented with an OPEX Benchmarking and ICH Q10 maturity assessment tool specifically developed for use with the APQ program by the University of St.Gallen, Switzerland. Used in conjunction with the APQ self-assessment tools for...

Featured in this edition of iSpeak Reading Roundup, are the top blog posts from December 2020. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.

As we enter the new year, this is the perfect time to make the 2021 ISPE Aseptic Conference part of your personal professional development plans. The virtual conference will allow participation from across the globe with no risk to pandemic exposure. The three-day format with shorter sessions will...

Lou Kennedy, Nephron Pharmaceuticals’ President & CEO and active ISPE Member, was recently honored with a 2020 Business Leader and Public Servant of the Year Award. We spoke with Lou to learn more about her company, the many initiatives she and Nephron are undertaking on behalf of pharma, Nephron’s...

The 2021 ISPE Aseptic Conference 30th Anniversary will be held on 15 – 17 March offering attendees several unique perspectives and case studies across two separate tracks. For many years, the ISPE Aseptic Conference has been an integral part of my professional career and the most important kick-off...

Featured in this edition of iSpeak Reading Roundup, are the top blog posts from November 2020. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.

It is time to celebrate the 30th anniversary of the ISPE Aseptic Conference at the 2021 ISPE Aseptic Conference. Hard to believe, isn’t it?

The Life Sciences industries adhere to strict documentation practices to prove quality and compliance. We’re all familiar with the truism “If it isn’t written down, it didn’t happen.”

FDA Commissioner Stephen M. Hahn, MD, spoke about the lessons learned from COVID-19 in a presentation during the ISPE Annual Member Meeting on 5 November at the 2020 ISPE Annual Meeting & Expo. He discussed how the FDA has been responding to the pandemic, including how actions taken in response to...

2020 ISPE Europe Annual Conference This article covers a regulatory panel discussion at the virtual 2020 ISPE Europe Annual Conference on the topic of Distant Assessments on GMP and Inspection Reliance. Driven by digitalization, these assessments help the industry and regulators manage inspection...