21 September, 2023
iSpeak Blog
PIC/s Annex 1, and the WHO Annex 2 for the manufacturing of sterile products took effect on 25 August 2023, and the time to attend the 2023 ISPE Pharma 4.0™ and Annex 1...
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Global News
||19 September, 2023News & Press ReleasesISPE is proud to introduce two significant initiatives aimed at benefitting the field of pharmaceutical compounding—the release of the " ISPE Guide: 503B Compounding –...
|15 September, 2023iSpeak BlogThe pharmaceutical industry is constantly evolving, placing a significant emphasis on emerging technologies that facilitate quicker access of medications for patients globally... -
Global Events
Pharmaceutical Technology Transfer Training Course
This training course on Pharmaceutical Technology Transfer identifies criteria for successful technology transfer and provides ‘how to’ examples which can be individually...HVAC & Environmental Control for Life Science Facilities Training Course
This training course focuses on common issues and problems in the operation of a facility and maintaining readiness for cGMP inspection. Topics include control system alarm...Commissioning and Qualification Training Course
Worldwide Regulatory expectations and guidance as led by FDA and the EU have stated that all Pharmaceutical Quality Systems should apply a QRM (Quality Risk Management)... -
Videos
|VideoIntroducing the Future of ISPE Guidance Documents At ISPE, our mission has always been to connect knowledge, operational excellence and regulatory insights. In keeping with this commitment, we are excited to announce...
|VideoThe 2023 ISPE Biotechnology Conference in Dublin from 26-27 June 2023, provided both in-person and virtual attendees an overall view of the development and manufacturing of biotechnology products. For current biotech...
|VideoThank you to the program committee, speakers, attendees and all those involved for a successful 2023 ISPE Europe Annual Conference! See you next year in Lisbon, Portugal! The 6 main tracks at this conference were...
Shortages of essential medicines around the world have been an ongoing concern for patients, caregivers, and regulators and have been exacerbated by the COVID-19 pandemic. Many regulators have instituted requirements for reporting potential or actual...
