"Calif[f], 70, is a well-regarded cardiologist and researcher who takes the helm at the FDA for a second time 13 months after it last had a permanent leader."
To help our stakeholders understand these requirements, the FDA is issuing guidance documents intended to assist trading partners in complying with the law and achieving a safer, more secure and more trusted drug supply chain.
FDA CGMP Online Training – trusted GMP online training courses offered by SkillsPlus International Inc. According to the article, there are 6 questions to ask: What is the training need? (What has driven this request?) What are the desired outcomes? (What does success look like?) Who is the target audience? What should they (the target […]
FDA GMP QSR cGMP Training Courses by SkillsPlus International Inc. According to the article: “The medical device industry hailed President Trump’s signing into law a bipartisan federal spending package that brings in an end to a tax the medical technology industry has been fighting against for the last decade. The 2.3% tax on medical device […]
“The Site Selection Model (SSM), used by CDER staff to prioritize manufacturing sites for routine quality-related inspections, considers risk related to drug (drug substance and finished product) quality as may arise from violations of the CGMP requirements in the Food Drug & Cosmetic Act (FD&C Act). The SSM will use risk factors consistent with section […]