On Demand Webinars

  • Statistical Analysis of Gages Recording
    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 Recording
    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) Recording
    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 Recording
    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 Recording
    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 Recording
    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 Recording
    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 Recording
    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...
  • Risk Management and Risk-Based Monitoring Recording
    Description: This course provides an understanding of risk management principles and makes the links between study level risk management and the implementation of risk based monitoring. New regulations with regard to Risk Based Monitoring were released by FDA in...
  • Expanding Your Quality Toolbox using a Risk Based Approach Recording
    Description: The awareness and use of data is a direct reflection of the maturity of a company’s management system. Quality Tools are the lens, collectors and sifters through which we interact with our data. In this workshop we will...
  • Transition to ISO 9001:2015 with Confidence Recording
    Description: The publication of ISO 9001:2015 and its impact on many related industry-specific standards will present a unique opportunity for organizations to evaluate and improve their existing QMS. With the publication of ISO 9001:2015, organizations now face the next...
  • Application of Lean Six Sigma Methodology for Regulated Industries Recording
    Description: This course teaches any employee the Lean Six Sigma philosophy and how to apply it in their job on a day-to-day basis. Participants will learn each phase of Six Sigma’s DMAIC methodology and their use as a part...