October 5, 2021
The following article covers a transcript during training done by Teresa Gorecki and Kenneth Ray, where they discuss how Quality Pulse aligns with ICH Q10. Gorecki: Very well. Ken, do you want to take that first? Ray: Sure, I’ll take a stab at it. If you look at Q12 and some of the content that’s […]
September 21, 2021
The following article is taken from June 15th Webinar – “Create a Quality Culture to Aid Risk Management: Dynamic Behaviors that Achieve Quality and Business Objectives”. Challenges of Weak or Ambiguous Quality Culture Now let’s look at a third quality culture scenario, where you have a weak or ambiguous culture. Notice in this one that expressed values […]
August 23, 2021
The article below is a transcript taken from June 15th Webinar – “Create a Quality Culture to Aid Risk Management: Dynamic Behaviors that Achieve Quality and Business Objectives”. This section of the webinar focuses on the scientific basis of Quality Pulse. Introduction Edgar Schein was a researcher in the 1950s and ‘60s in organizational dynamics […]
August 18, 2021
In 2020, COVID-19 — and more recently its Delta variant — wreaked havoc on an orderly return to business as usual. But recently progress has been made as the FDA said they have resumed some of its foreign inspectional activities and has begun transitioning to its standard operations for domestic inspections. But be forewarned, the […]
August 9, 2021
The following article covers a transcript taken from June 15th Webinar – “Create a Quality Culture to Aid Risk Management: Dynamic Behaviors that Achieve Quality and Business Objectives”. The transcript covers a new quality culture paradigm section from the webinar. These two slides date back almost 20 years, and the FDA intuitively saw that culture […]
July 14, 2021
Compliance Architects® is pleased to announce that it has partnered with CherryCircle Software to support implementation and on-going support needs of CherryCircle’s clients. QbDVision Platform CherryCircle Software has developed a one-of-a-kind platform (QbDVision Digital CMC™) that brings state-of-the-art digital infrastructure to pharma and biotech process development. The result: a platform purpose-built to accelerate the drug […]
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