April Education: Intro to Engineering Fundamentals

16 April 2019 - 16 April 2019
The April ISPE Education program is going retro with a focus on the Fundamentals of Engineering. This event will provide a refresher on the engineering behind some of the basic equipment and systems we use in the FDA regulated industries, such as...

Regulatory Commenting

As regulatory agencies invite public comment on a new or revised regulation or guidance they look to ISPE for input on the latest scientific and technical developments. ISPE submits official comments when we can provide...
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iSpeak Blog
Disaster Recovery in the Pharmaceutical Industry: Lessons Learned from Conflict and Catastrophe

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...

Cell and Gene Therapy Series: Cellares Plant Tour

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...

ISPE Training: GMP Auditing for Quality Assurance Training Course (G07)

26 June 2025 - 27 June 2025
Limited time offer: REGISTER 1 for 1 before 30 April! 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...

APRIL | THERAPEUTIC THURSDAYS

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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Baseline Guide Vol 6: Biopharmaceutical Manufacturing Facilities 3rd Edition

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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...
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iSpeak Blog
ISPE Members Continue Training Health Authorities on ICH Q12 Implementation

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.

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iSpeak Blog
Good Engineering Practice in Investment Management: Optimizing Pharma for the Future
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...

WEBINAR: Quality Inspection Methods for Pharmaceutical Packages in Compliance with Latest Pharmacopeia Annex I “Sterile Product Manufacturing”

2 July 2025 - 2 July 2025
WEBINAR: Quality Inspection Methods for Pharmaceutical Packages in Compliance with Latest Pharmacopeia Annex I “Sterile Product Manufacturing” 2 Jul 2025 5.30-6.30pm SGT | Online ABSTRACT The presentation will be focused on USP listed methods for...
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