Quality Management

If you can't find what you want, Ask Us.

Refine Your Results

reset

Filter by Category

Location

Dates

FEATURED VENDORS

Showing 1-16 of 16 results Sort by:

Courses

  • 1 Request Info

    Statistical Sampling Plans - Methods and Applications at San Francisco, CA

    Overview: Many companies use acceptance sampling as a standard business practice. The most common applications use attribute sampling based on ANSI/ASQ Z1.4 and Zero Acceptance Number Sampling Plans by Nicholas L. Squeglia. These common methods are not always the best approaches. This seminar will expose to you to a variety of methods and help you understand when to use them. While many of the examples come from medical device manufacturing because of the rigid regulatory structure, the methods apply in aviation, defense, and other manufacturing settings. This unique hands-on course provides attendees with a solid understanding of acceptance sampling methods and their application to manufacturing. The course delivers tools, templates, and insight that will allow participants to choose and implement the best sampling methods for their application.
  • 2 Request Info

    ISO/IEC 17025:2005 and Laboratory Accreditation

    QMS is the catch phrase for accreditation and is the backbone of ISO/IEC Standard 17025:2005. The Quality System Manual (QSM) is the bible in a QMS environment because, much like its predecessor, Good Laboratory Practice (GLP), it contains the policies that the laboratory is expected to follow to achieve quality results. It is in fact only the "what to do" component of a QMS. What is also needed are the "how to do it" or procedures and methods and finally the controls or evidence that it was done properly.
  • 3 Request Info

    Risk Analysis and Design of Experiments in Process Validation and Development

    The use of DOE methodology provides a means to identify process parameters which impact product quality (critical process parameters) and determine the functional relationship that links the process parameters to that critical quality attributes. Screening designs, such as 2k factorial and D-optimal designs are used to determine critical process parameters. Response surface designs, such as Central Composite Designs (CCDs) and I-optimal designs are used to model the functional relationship between those critical process parameters and the critical quality attributes. This course will begin by presenting a primer on statistical analysis, focusing on the methods required for analysis of designed experiments. It will then present the steps to DOE, while demonstrating valuable risk management tools (Ishikawa and FMEA) which can be use pre and post DOE studies. Next, participants will learn to generate and analyze multiple screening and response surface designs;
  • 4 Request Info

    Risk Analysis and Design of Experiments in Process Validation and Development

    This course will begin by presenting a primer on statistical analysis, focusing on the methods required for analysis of designed experiments. It will then present the steps to DOE, while demonstrating valuable risk management tools (Ishikawa and FMEA) which can be use pre and post DOE studies. Next, participants will learn to generate and analyze multiple screening and response surface designs; the participants will leave with an understanding of why and how each are used. Then, the participants will learn how results of the studies can be presented. Lastly, using the results of the studies, the risk management tools will then be updated.
  • 5 Request Info

    Advanced Tools and Techniques for Data Analysis

    This 2-day advanced analytics seminar will introduce you to predictive analytics techniques, so you can frame strategic and operational questions involving marketing, finance, and operations or other real-world business applications.

    In this hands-on course, you will cover a variety of analytics tools, such as histograms, ANOVA analysis, A/B testing, Pareto analysis, clustering, box plots, scatter diagrams, partitioning, unstructured text analysis, and multivariate regression analysis. Best of all, no background in statistics or programming is required. As long as you have a basic understanding of spreadsheets, you will learn how to manipulate complex data sets so you can gain insights that are not possible with common business intelligence techniques.

  • 6 Request Info

    Verification vs. Validation in Regulated Industries by John Chapman

    Areas Covered in the Webinar: Verification & validation types. Definitions. Design control. Process control. Application. Consequences of poor verification & validation. Why verification & validation makes good business sense?
  • 7 Request Info

    Medical Device Risk Management A to Z - Best Practices for Effectiveness and Efficiency by Dr. Harvey Rudolph, HRRM, LLC (Ex-FDA Official, ISO 14971 S

    Learning Objectives: To educate attendees on the vital reasons for risk management and the key role it plays in the product life cycle To demonstrate the requirements of ISO 14971, how they reflect FDA concerns To clarify how risk management impacts international standards, such as IEC 60601, and how to conform to risk management requirements To provide practical application experience and skills in the process and tools of risk management, enabling attendees to be effective risk managers To teach how to establish a quantitative risk management system and one that complies with EN/ISO 14971:2012 To provide attendees with the Dos and Don'ts for an effective and efficient risk management system.
  • 8 Request Info

    Analytical Instrument Qualification and System Validation Dr. Ludwig Huber, Director and Chief Editor, LabCompliance

    Learning Objectives: Learn about the regulatory background and requirements for laboratory instrument qualification and system validation Understand the logic and principles of instrument qualification and system validation from validation planning to reporting Understand and be able to explain your company’s qualification and validation strategies Be able to independently prepare execute test protocols, this includes setting specifications and acceptance criteria Understand how to review and approve qualification and validation protocols Be able to develop inspection ready qualification and validation deliverables Learn how to avoid and/or respond to FDA inspectional observations and warning letters.
  • 9 Request Info

    FDA's Refuse to Accept Policy - How to Prepare 510 (K) Submission to Avoid the Pitfalls of the Policy

    Learning Objectives Upon completing this course participants will understand: Difference between a traditional, abbreviated and special 510(k) and when to submit each type of 510(k) When to file for a new device, a change in the intended use or a change in the technology of a cleared device What is contained in a traditional, abbreviated and special 510(k) submission package The submission package, user fees and making an eCopy What is substantial equivalence and what’s required to show substantial equivalence What’s required on the labeling and IFU Which performance tests should be conducted and how to present the data to the FDA The requirements for a risk management plan and report Understand the FDA’s Refuse to Accept Policy What is required in a submission for software controlled devices How and when to use third party reviews When clinical data may be required.
  • 10 Request Info

    Quality Management, GMP and Regulations - Impact on Food, Seafood and Nutritional Supplements

    Understand the importance of food and nutritional supplement GMPs in protecting the public See the impact of poor GMP performance Become a HACCP subject matter expert Understand the impact on product quality and on business success Know how facility design affects product quality Understand the dos and don’ts of product promotion, websites and social media Learn about GMP validation – when is it required? Understand how cleaning agents work and the best way to choose a cleaning agent See the impact of proper documentation and record keeping Understand why cleanliness is the key to success.
  • 11 Request Info

    Introducing The Tools For Continuous Improvement

  • 12 Request Info

    Toast Kaizen: An Introduction To Lean Principles

  • 13 Request Info

    In Search of Quality Volume 1: Quality Through People

    See how Wallace Company, a Malcolm Baldrige Award Winner, changed from a rigid hierarchical organization into a model of teamwork and personal empowerment through a commitment to quality. Hosted by In Search of Excellence co-author Bob Waterman.
  • 14 Request Info

    Creating Real-Time Quality

  • 15 Request Info

    ISO 9000:2000 Internal Auditing Course

    ISO 9000:2000 INTERNAL AUDITOR Training,1-3 days,What are changes to theISO 9000:2000?,What to Look For As an Auditor,Auditing Techniques,Developing a Checklist,Questioning Techniques&Perform an actual audit.
  • 16 Request Info

    Collaboration 4 Project Results

    High energy, interactive 3-day PMBOK-based course for Proj.Mgrs. Teaches processes/ techniques for shaping, energizing, motivating project teams to get faster/better results with Collaboration,“The Tenth Knowledge Area.Bob Moir 404.338.0715