17 October 2022 - 18 October 2022
Invitation to Seminar of ISPE Affiliate D/A/CH & Nordic By rCOP Pharma water and Steam systems Dear Sir or Madam, dear ISPE D/A/CH & Nordic members, the ISPE D/A/CH & Nordic rCOP (regional „Community of Practice) „Pharma Water & Steam Systems“ invite...
Maintaining the principles and framework of the First Edition, GAMP® 5 (Second Edition) is newly revised and expanded to address the increased importance of service providers, evolving approaches to software development, and the more widespread use of software tools and automation. It highlights the use of Critical Thinking by knowledgeable and experienced SMEs to define appropriate approaches.
iSpeak Blog

Digital transformation is the novel use of digital technology, including instrumentation and control systems, to solve traditional problems in a transformative manner. These digital solutions enable inherently new types of innovation and creativity, rather than simply enhancing, and supporting traditional methods.

Media & Press Releases
29 July 2022
ISPE has been honored as the winner of a 2022 APEX Award for Publication Excellence in the Technical & Technology Writing category for the article “AI’s Promise for ATMPs” published in the November-December 2021 issue of Pharmaceutical Engineering®...
iSpeak Blog

FOYA Winners in the Supply Chain Category exemplify the novel application of process manufacturing techniques, innovative design concepts, new technologies, and unique solutions that exemplify the next generation of agile, flexible, efficient, and effective new and existing pharmaceutical and biotechnology facilities. This includes implementation of commercially available and custom developed...

iSpeak Blog

Featured in this edition of iSpeak Reading Roundup, are the top blog posts from June 2022. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.

iSpeak Blog

While everyone is facing new speed to market expectations, we should consider and discuss why global regulatory barriers are increasing, why science- and risk-based strategies often mean more data are required, and why regulatory approval for new technologies and new medicines seems more challenging than ever before. We can no longer afford to delay innovation, product and process...

8 September 2022 - 8 September 2022
8 Sep 2022 5.00-6.30pm SGT | Online Hosted by: Abstract: Manufacturers are required to develop a set of control strategies to confirm their process performance and product quality. Annex 1 introduces a “Contamination Control Strategy” (CCS) approach...
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