Food, Drugs & Biologics

  • Sale! Investigator initiated trials- What are we doing to ensure human subject protection ?
    Description: This 1 hour virtual seminar will help you understand the key issues and challenges associated with investigator initiated trials. Investigator initiated trials are very important as they are important connection for the translation of research from bench to...
  • Risk Management and Risk Analysis Techniques in Clinical Trials
    Description: If you are currently involved in clinical trials either as a CRA, project manager, investigator or sponsor, this seminar will provide you with an overview of risk factors in clinical trials and possible ways to mitigate, control, assess...
  • Quality Lean Auditing
    Description: The competitive market and the business goal for growth are some of the variables that dictate optimization of resources, including an effective quality audit program (system, product or process). Audit findings that can trigger measurable action plan, measurable...
  • Confidence / Reliability Calculations & Statistically Valid Sample Sizes
    Description: All manufacturing and development companies perform testing and/or inspections that involve concluding whether or not a product or lot is acceptable vs. design or QC specifications. Such test/inspections may occur during design verification/validation or during incoming or final...
  • Statistical Analysis of Gages
    Description: The seminar begins with an examination of the fundamental vocabulary and concepts related to metrology. Topics include: accuracy, precision, calibration, and “uncertainty ratios”. Several of the standard methods for analyzing measurement variation are then described and explained, as...
  • Better Alternatives to Sampling Plans
    Description: The seminar begins with an examination of ISO and FDA regulations and guidelines regarding the use of statistics, especially in regards to Sampling Plans. The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4,...
  • Statistical Process Control (SPC)
    Description: All companies want to improve the quality of their products. Attempts to improve product quality need to be structured in such a way that they have a reasonable chance of success and the cost/benefit ratio is appropriate. The...
  • U.S. FDA's Strategic Priorities - 2015 and Beyond
    Description: This webinar will discuss about two “Strategic Priorities” that the FDA has published to emphasize their future directions vis a vis regulated industry and public safety. Each year companies are to perform a complete review of their quality...
  • Risk Management in Clinical Trials
    Description: ICH Q9 – Quality Risk Management has been present as an FDA Guidance Document for almost 10 years, and this advocates the utilization of a risk assessment and then risk analysis methodology across all aspects of the pharmaceutical...
  • Risk-based Outsourcing
    Description: The regulatory background for the Pharmaceutical industry as a whole now requires a ‘risk based approach’ to all activities and that will of course include Outsourcing. Lack of Outsourcing Oversight is a very common finding during audits and...
  • User Acceptance Testing
    Description: Current regulations expect that all users are appropriately trained and that must include being trained how to effectively perform UAT. This course provides an understanding of the role of users in system validation and covers good documentation practice...
  • Computer System Validation
    Description: This course provides a background to CSV regulations and guidance on the overall process of validation and the importance of good documentation. Computer System Validation is a regulatory requirement under ICH GCP and 21 CFR Part 11 but...