iSpeak Blog

In 2023, the ISPE Commissioning and Qualification (C&Q) Community of Practice (CoP) conducted a survey on the adoption of integrated C&Q, focusing on the use of paperless/digital systems for planning, executing, and reporting C&Q activities. According to the survey, 74% of respondents anticipated using digital validation tools (DVTs) for C&Q by 2024. “Over the last five years,...

21 August 2025 - 21 August 2025
Late Summer Connections: Join ISPE Nordic for Networking & New Faces in Helsinki Join the ISPE Nordic Affiliate for an informal Membership Drive & Happy Hour designed to reconnect, welcome new faces, and strengthen our life science community across...
Good Practice Guide: SMEPAC - Standardized Methodology for the Eval of Pharm Airborne Particle Emissions 3rd Edition
Published: December 2024 Pages: 122 Table of Contents Special Pricing for Emerging Economies This Guide was originally titled ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment. As in previous
iSpeak Blog

In the pharmaceutical industry, disaster recovery is not just about protecting business continuity; it is about safeguarding patient safety, data integrity, and the entire supply chain. The increasing complexity of global pharmaceutical operations exposes companies to a broad spectrum of risks, ranging from man-made disasters such as geopolitical conflicts to natural disasters that can cripple...

22 May 2025 - 22 May 2025
Cell and Gene Therapy Series: Cellares Plant Tour Location Cellares 95 Corporate Drive Bridgewater, NJ 08807 Time Thursday, May 22, 2025 4:00 - 8:00 pm As part of our series on Cell and Gene Therapy, the ISPE NJ chapter is pleased to announce a...
26 June 2025 - 27 June 2025
GMP Auditing for Quality Assurance Training Course (G07) 26 - 27 Jun 2025 | 9.00-5.00pm SGT The Chevrons, 48 Boon Lay Way, Singapore 609961 IN-PERSON! Overview Auditing is a critical function within a pharmaceutical company. It provides management...
17 April 2025 - 17 April 2025
Join us for our monthly Therapeutic Thursdays Mixer Event. We look forward to seeing everyone to network and collaborate with influencers and key players in the Bio/Pharma industries.
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This third edition of the ISPE Baseline® Guide: Biopharmaceutical Manufacturing Facilities intends to further reinforce the concepts described in the second edition of the Guide, provide examples of how these concepts...
iSpeak Blog

ISPE’s Q12 Implementation team, a working group under the auspices of ISPE's Product Quality Lifecycle Implementation (PQLI)® committee, continued their series of training events with a well-attended course delivered to Singapore’s Health Sciences Authority (HSA) in November 2024.

iSpeak Blog
What does it take to stay ahead in the volatile and fast world of pharmaceutical manufacturing? How do we ensure to invest smartly into the future? Join ISPE at the 2025 ISPE Europe Annual Conference, in London, United Kingdom, to hear about why the industry needs to look beyond just acquiring the latest, cutting-edge technology and how good engineering practices drive efficiency, compliance, and...
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