Clinical & Laboratory

  • Verification recently ranked in the top 5 reasons for Warning Letters from the FDA! Verification and Validation appear frequently in ISO 13485, MDSAP, 21 CFR 820, 21 CFR 211, ISO 14971, US Pharmocopeia, and many such documents. Many people...
  • Documentation is the key to GMP compliance and ensures traceability of all development, manufacturing, and testing activities. Documentation provides the route for auditors to assess the overall quality of operations within a company and the final product. The webinar...
  • There are many things the FDA-regulated industry—including medical device manufacturers and professionals—should know about the FDA’s current inspection policy to adequately implement the good manufacturing practices (GMPs). The consequences of failing to comply with FDA regulations can lead to...
  • A Highly regarded talk during recently held ASQ World Conference on Quality and Improvement. This course is meant to be a needed introduction to risk management for a broader range of professionals. Risk Elimination. Risk Management. Risk Mitigation. These...
  • A Highly regarded talk during recently held ASQ World Conference on Quality and Improvement. This course is meant to be a needed introduction to risk management for a broader range of professionals. Risk Elimination. Risk Management. Risk Mitigation. These...
  • Effective documentation of analytical procedures is essential to ensure that testing required by regulatory agencies is performed correctly and consistently. This webinar will cover some of the common mistakes made while writing analytical procedures, and will give examples of...
  • CarolynTroiano
    Organizations governed by FDA must adhere to strict requirements relative to data being captured, analyzed, reported or stored on computer systems. As such, organizations must be able to manage the data effectively, realize value from it, minimize the cost,...
  • “Good documentation practices” is a “current” industry practice that is reviewed and cited by federal regulators when audited. Pharmaceutical/Biological document are legal documents that are controlled by all regulatory agencies. The person or persons responsible for filling out these...