Actualización del estatus regulatorio en la determinación de nitrosaminas.

18 November 2021 - 18 November 2021
Las N-nitrosaminas son compuestos orgánicos que se han colocado de manera preponderante en el proceso de fabricación de medicamentos debido a su carácter genotóxico, carcinogénico y mutagénico. En los estudios realizados por parte de diferentes...
Read, Learn, Innovate: Top Blog Posts from September 2021
iSpeak Blog
Read, Learn, Innovate: Top Blog Posts from September 2021

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

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ISPE Good Practice Guide: Maintenance 2nd Edition

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Maintenance can impact both the quality of products and the compliance of pharmaceutical processes. Maintenance programs have long been recognized as critical to the success of the operations they support. The ISPE Good...
ISPE Member Spotlight: Erich Bozenhardt
iSpeak Blog
ISPE Member Spotlight: Erich Bozenhardt

Erich Bozenhardt is a BioProcess SME and internationally recognized authority in the domains of cell and gene therapy and bioprocessing. He is a Lead Process Engineer in Regenerative Medicine Operations at United Therapeutics Corporation. During his career, Erich has led the process activities for several biopharmaceutical projects, provided internal and external project leadership, is a...

Biotech days: insight into vaccines and related challenges of the supply chain

24 November 2021 - 25 November 2021
ASCCA, ISPE Italy Affiliate, PDA Italy jointly organize a two-session Webinar entitled Biotech days: insight into vaccines and related challenges of the supply chain Chairs Cristiana Campa - GSK Vaccines TBA Dear Members and friends of ASCCA, ISPE...

Practical & Value-added Statistics for the Non-statistician / Session 2

12 November 2021 - 12 November 2021
Practical and Value-added Statistics for the Non-statistician Session 2: Statistics for PPQ Accelerated timelines, complex supply chains, data constraints, evolving compliance requirements… These are just a few of the challenges of today’s...
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ISPE Good Practice Guide: Knowledge Management in the Pharmaceutical Industry

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In 2008, ICH Q10 identified Knowledge Management (KM) and Quality Risk Management (QRM) as the enablers of an effective Pharmaceutical Quality System (PQS). Since then, the pharmaceutical industry has been slow in...
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Meet Your Newly Confirmed Keynote Presenter for the 2021 ISPE Annual Meeting & Expo

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Lou Kennedy, CEO and Owner Nephron Pharmaceuticals Under Kennedy’s leadership, Nephron has experienced unprecedented growth. The company is now nearly 2,000 employees strong and produces more than 1 billion doses of life...
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