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Feature
|08 March, 2021iSpeak BlogThe current COVID-19 pandemic has heightened the awareness and attention to virus safety and risk mitigation for manufacturers. Each manufacturer has a strategy in place to...
|VideoInternational Women's Day (March 8) is a global day celebrating women's social, economic, cultural, and political achievements. The theme for International Women’s Day 2021 is Choose to Challenge. It’s a clear call to...
|05 March, 2021iSpeak BlogOn February 8, 2021, the ISPE Emerging Leaders Committee launched ISPE’s first virtual International Hackathon. 51 ISPE Student and Recent Graduates participated in the event... -
Calendar Of Events
Cleaning Validation Principles Training Course
This course covers the risk-based approach to cleaning development and verification; risk analysis; procedures and evaluation tools including FMEA / FMECA, master planning...GAMP® Data Integrity 21 CFR Part 11 Training Course
This GAMP Data Integrity 21 CFR Part 11 Training Course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems...GMP Fundamentals for the Pharmaceutical Industry
This course is designed to help participants understand the GMPs as they relate to the pharmaceutical industry. Participants will gather information about both European... -
Videos
|VideoInternational Women's Day (March 8) is a global day celebrating women's social, economic, cultural, and political achievements. The theme for International Women’s Day 2021 is Choose to Challenge. It’s a clear call to...
|VideoYour professional development is critical to meeting cGMP regulations and can also be the difference between successful operations and regulatory violations. ISPE Training courses are designed to give you the hands-on...
|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...
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.
New Eurasian Economic Union (Eurasia) Affiliate formed
ISPE would like to recognize our newly formed Eurasian Economic Union (Eurasia) Affiliate. The Affiliate provides a local forum through which professionals in Russia, Armenia, Belarus, Kazakhstan, and Kyrgyzstan can contribute to the advancement of the pharmaceutical manufacturing industry.
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...
Not a Member Yet?
Whether networking at events or collaborating through our Communities of Practice, the value of an ISPE membership is in the connections made between pharmaceutical industry professionals and Regulators to collaborate on solutions to common goals and challenges.
