ISPE Expert Xchange: COVID-19 and the Vaccine

18 November 2021 - 18 November 2021
Next-Generation Virtual Experience Complimentary Learning Level: Intermediate Session Length: 4 hours In response to the recent COVID-19 pandemic, the urgency for rapid development, authorization/approval & supply continuity of a new mRNA platform...
How Knowledge Management Can Improve Quality and Increase Efficiency
iSpeak Blog
How Knowledge Management Can Improve Quality and Increase Efficiency

ICH Q10 outlines three objectives: achieve product realization, establish and maintain a state of control, and facilitate continual improvement. Embracing these objectives can be best achieved using the dual enablers, Knowledge Management (KM) and Quality Risk Management (QRM). The pharmaceutical industry has made significant progress in adopting QRM into systems and processes. However, the...

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Affiliates/Chapters News & Press Releases

ISPE Belgium Affiliate Seminar - 16 Nov 2021 – Registration is Open!

12 October 2021
Don’t miss next seminar (face-to-face) about “Technologies of the future. Going beyond the success story” with vitual GSK Wavre site visit, networking opportunities and table top exhibition. Detailed agenda (presentations, workshops) and registration...
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Requirements for Computerized Systems Validation and Compliance

This online course describes regulatory requirements and expectations regarding the validation and compliance of computerized systems used in the manufacture of pharmaceuticals, biologicals, and medical devices. It does not cover the detailed requirements of 21 CFR Part 11, except for the...
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Cloud Concepts - Cyber Security and Block Chain

This online course will explore the pros and cons of cloud-based computing. Attendees will gain an understanding of what "the cloud" is and how it's both different, and similar, in comparison to software solutions that run on company-owned servers. Data concerns will also be addressed and aspects of...
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Adaptive Mobile BioPharma Production Suite: Case Study

This online training session will cover a case study of the selection, installation and operation of a flexible design and production platform that allows for clinical vaccine production. This unique cGMP mobile adaptive biopharma production platform was placed into operation in New Haven, CT in...
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Cleaning Fundamentals for the Pharmaceutical Industry

Clean-in-place design integration and cleaning chemical selection are vital components of every pharmaceutical manufacturing process; indeed, all pharmaceutical companies employ some type of cleaning application every day. As a result, FDA inspections of cleaning processes have been occurring with...
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