25 February, 2021
iSpeak Blog
Aseptic filling of parenterals is one the most challenging tasks within pharmaceutical manufacturing. There is a wide range of topics that fall under this umbrella, from more...
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Global News
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|VideoYour professional development is critical to meeting cGMP regulations and can also be the difference between successful operations and regulatory violations. ISPE Online Live Training courses are designed to give you the...
|24 February, 2021iSpeak BlogFor as long as I can remember, I have always felt I was different. However, I have never felt it more than when I was in foreign countries, interacting with people from all... -
Chapter Events
|09 March, 2021
Secondary Packaging Solutions for a Post Covid World
Secondary Packaging Solutions for a Post Covid World How Nosco and Antares Vision Are Leading the Way in Product Launches, Brand Protection and Serialization Format...|08 March, 2021Innovating Women's Healthcare
A virtual joint event from the largest ISPE chapters in California Complimentary Webinar for ISPE Members and $35 for Non-Members Innovating Women’s Healthcare A Women in...|04 March, 2021Your Mic is Muted: How New Grads Are Navigating the Job Market During COVID-19
WEBINAR EVENT Your Mic Is Muted How New Grads Are Navigating the Job Market During COVID-19 REGISTER -
Videos
|VideoYour professional development is critical to meeting cGMP regulations and can also be the difference between successful operations and regulatory violations. ISPE Online Live Training courses are designed to give you the...
|VideoWhat can you expect from the biggest aseptic event of the year? Interactive discussions, leading authorities, case studies, industry-critical topics, global regulators, networking, unparalleled insights, and more! Don't...
|VideoAn ISPE Membership gives you the opportunity to be a part of a community of 18,000+ global pharma professionals, working together to advance the solutions that lead to improved patient health. It’s essential that you're...
Guidance Documents
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Good Practice Guide: Maintenance 2nd Edition
Good Practice Guide: Maintenance 2nd Edition
PublishedMaintenance 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. -
Good Practice Guide: Equipment Reliability
Good Practice Guide: Equipment Reliability
PublishedEquipment reliability is concerned with the risk of failures in equipment and processes, providing focus on equipment availability, fitness for purpose, and cost. The strategy and tactics of reliability contribute to realizing the value of equipment throughout its useful life and mission. -
APQ Guide: Corrective Action & Preventive Action (CAPA) System
APQ Guide: Corrective Action & Preventive Action (CAPA) System
PublishedThe ISPE APQ Guide: Corrective Action and Preventive Action (CAPA) System provides a quality management framework for assessing and advancing CAPA system maturity level by evaluating several key components. -
GAMP RDI Good Practice Guide: Data Integrity by Design
GAMP RDI Good Practice Guide: Data Integrity by Design
PublishedThis ISPE GAMP® RDI Good Practice Guide: Data Integrity by Design supports organizations as they embrace and implement a holistic approach by leveraging data governance and knowledge management activities to drive continual improvement in data integrity.
Women in Pharma® is a place where women and men—especially those new to the industry—can access a network of mentors, role models, and educational resources to support their professional success. The widespread global interest and...
