Food, Drugs & Biologics

  • Pharma Graphics
    Description: This webinar will guide on how to effectively use Visual Displays of Data to rapidly discover, understand, and effectively communicate results. Effective collection, analysis and communication of data are central to process and product development and continued process...
  • Sale! DeNovo Classification Process
    Description: This webinar provides information on FDA’s DeNovo classification process. The webinar explains how a device classified as a Class III device but has the risk level of a Class I or II device may be downclassified to its...
  • Annual Reports for Approved PMAs
    Description: This webinar describes the information required by FDA to be submitted in a PMA annual report. The webinar also discusses FDA recommendations for level of detail the applicant should provide in the PMA annual report. Also addressed are...
  • Sale! Drug Development & Discovery by FDA Standards
    Description: The Drug Discovery and Development (but also the biologics and medical device) process is a very complex process with every participant focusing on their particular piece of discovery or development. You can spend a lifetime in your part...
  • Sale! Regulatory Issues in Pharmacogenomics
    Description: This presentation will begin by giving an overview of Pharmacogenomics and how it is used in drug development. It will then identify the agencies that regulate Pharmacogenomics data, and explain what the regulations are. It will then go...
  • Good Clinical Practices
    Description: Adherence to the principles of good clinical practices (GCPs), including adequate human subject protection (HSP) is universally recognized as a critical requirement to the conduct of research involving human subjects. Many countries have adopted GCP principles as laws...
  • Incorporating Risk Management into Process Improvement
    Description: CBS Newsman Eric Sevareid once said, “The chief cause of problems is solutions.” Every organization engages in process improvement activities, but too often, these activities also have unintended negative consequences. A small mistake can cost a company millions...
  • Calibration and Assuring Accurate Measurements
    Description: Assuring accurate measurements is important when establishing specifications during product design and development, during process validation and for assuring product performance while testing for lot release. Assuring accurate measurements accounts for a significant amount of time and resources...
  • Verification vs Validation
    Description: This webinar will focus on the difference between Verification vs Validation and how can we use them to improve the bottom line. If Verification &Validation are done right, the process and product should always conform unless there is...
  • Clean Room Design and Operation
    Description: Controlled environmental conditions are often used when making medical devices and pharmaceuticals. However, to make sure these clean rooms are continuously operating in a state of control can be a difficult task unless the appropriate controls are incorporated...
  • Quality Auditing for Added Value and Continuous Improvement
    Description: Oh no! The auditor is coming this week! Whether it is the FDA or an important customer or the Corporate Compliance Group, even pre-announced visits by these outside auditors can induce strain, apprehension and/or outright fear in many...
  • Benchmark for Cleaning Validation and Control
    Description: Cleaning validation is increasingly important in preventing cross contamination and interactions between active ingredients in subsequent batches run in the same equipment. This webinar will review principles of sterilization validation and using them as a benchmark for more...