The guideline for Good Clinical Practices, ICH E6 (R3) draft, and ICH E8 (R1) introduce Critical to Quality (CTQ) Factors. What are they? How should they be used as part of RBQM? And whatever happened to critical processes and critical data? ABOUT „mindsON RBQM“ WORKSHOPS mindsON RBQM is a series of workshops by Cyntegrity’s MyRBQM…Continue reading mindsON RBQM Workshop | Episode 23: What is a Critical to Quality Factor anyway? (Webinar | Online)
Schlagwort: Cyntegrity
mindsON RBQM | Episode 17: RBQM should be standardized, shouldn’t it? (Webinar | Online)
Language: English Time: 17.00 to 18.30 h (German time zone, CET) Price: 0 € (free of charge) Webinar: How much of RBQM can be standardized, and how much flexibility is still necessary? Some companies seem to always start from scratch, while others try to standardize as much as possible. What is right and what is…Continue reading mindsON RBQM | Episode 17: RBQM should be standardized, shouldn’t it? (Webinar | Online)
mindsON RBQM | Episode 16: RBQM implementation – Which existing roles need change, and what new ones (Webinar | Online)
Language: English Time: 17.00 to 18.30 h (German time zone, CET) Price: 0 € (free of charge) Webinar: Since Risk-Based Monitoring was introduced in 2013 by FDA and EMA, organizations have taken many different approaches to implementation. What activities typically need to be performed for RBQM to work well? Which roles usually perform these activities?…Continue reading mindsON RBQM | Episode 16: RBQM implementation – Which existing roles need change, and what new ones (Webinar | Online)