04 May, 2021
iSpeak Blog
You are an active and engaged ISPE Member! You sit on the ISPE Board of Directors, the ISPE Foundation Board, and the Steering Committee of Women in Pharma®. Can you share...
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Global News
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|01 May, 2021Sponsored ContentContinued Process Verification (CPV) is the lengthiest and most data heavy phase of process validation. It requires continuous monitoring of processes against defined limits...
|VideoJoin us on 6 May 2021 for the FREE live webinar "503B Compounding Pharmacies: Principles, GMPs, and Case Studies" to take an in-depth look at how this field has developed since section 503B was created as part of the... -
Chapter Events
|17 August, 2021
Vendor Night Outdoors at The Park in the Eureka Building
VENDOR NIGHT OUTDOORS in THE PARK at the EUREKA BUILDING in IRVINE In 2013, our Founder had his Eureka Moment: to offer Orange County’s entrepreneurs a centrally-located, all...
|16 August, 2021Greater Los Angeles Area Chapter - Golf Tournament at Strawberry Farms Golf Club in Irvine
Golf Tournament at Strawberry Farms Golf Club in Irvine Strawberry Farms Golf Club: Strawberry Farms is a par-71, 6,700-yard course that is set amid canyons and wetlands. The... -
Videos
|VideoJoin us on 6 May 2021 for the FREE live webinar "503B Compounding Pharmacies: Principles, GMPs, and Case Studies" to take an in-depth look at how this field has developed since section 503B was created as part of the...
|VideoTechnology and innovation in the pharmaceutical industry are more critical now than ever before as healthcare worldwide is straining from the COVID-19 pandemic. Even in these trying times, it is important to spotlight...
|VideoThe global pharmaceutical industry continues to face unexpected challenges in responding to the world’s pandemic. The impact on normal operations has been felt in companies of all sizes, with varying manufacturing...
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.
The ISPE Pharma 4.0™ Special Interest Group (SIG) launched in 2015 to provide a road map for new challenges of digitalization, Industry 4.0, and the smart factory. The Special Interest Group addresses how pharmaceutical industry...
