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Courses

  • 1 Request Info

    Customer Satisfaction Measurement

    Link your customer measurement to customer loyalty. Here are the current strategies, methods and tools used by major organizations to measure customer satisfaction!
  • 2 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.

  • 3 Request Info

    Risk Based Thinking in and Beyond ISO 9001:2015

    ISO 9001:2015's new clause for "actions to address risks and opportunities" is among the biggest revisions to the standard. Risks and opportunities that relate to waste or muda, and also to changes in technology, markets, and distribution channels are however not explicitly covered, and are therefore not explicitly auditable, even under the new standard. This credit risk mitigation presentation will therefore focus on use of the standard as a servant whose purpose is to promote the organization's competitiveness and profitability, rather than a master whose requirements the organization has to satisfy to get the ISO certificate. ISO 9001 becomes the servant when the organization uses it as a framework to drive continual improvement and to identify risks and opportunities that lie well beyond the scope of the standard.
  • 4 Request Info

    Introduction to Design of Experiments

    Design of Experiments is a vital tool for process improvement and root cause analysis. It allows experimenters to determine beyond a quantifiable reasonable doubt that an experiment improves the process, or that there is a difference between treatments; choices among the factors of the cause and effect diagram. While comprehensive mastery of DOE requires full college-level courses, enough basics can be taught in an hour to enable the attendee to know the key considerations in the design of an experiment, and also interpretation of its results. The material on hypothesis testing will also position the attendee to understand statistical process control (SPC) and acceptance sampling.
  • 5 Request Info

    Biotech/Biosimilar Products: Current and Emerging Analytical CMC Expectations

    Learning Objectives: Recognize the system of worldwide regulatory guidance applicable to biotech and biosimilar product CMC requirements Understand why requirements for biotech products are so different from those of chemical products Find exactly ‘where it is written’ for current and emerging CMC expectations for biotech/biosimilar products, and get copies of those regulatory documents See how to implement a staged approach to establishing specifications for release and stability testing Learn the current analytical technologies used for establishing biotech/biosimilar product characteristics and assessing comparability Select the appropriate methods for release and stability testing Design suitable qualification and validation exercises for method intended uses Establish stage-appropriate ICH stability protocols Learn the tiered approach for managing product reference standards Recognize how much R&D data are exposed to regulatory scrutiny
  • 6 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.
  • 7 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.
  • 8 Request Info

    Statistical Analysis for Product Development by Steven Walfish, President of Statistical Outsourcing Services

    Learning Objectives: Learn the technical details and rationale for selecting and analyzing well designed statistically based experiments. Develop the confidence to design and execute experiments that maximizes information in your day-to-day activities. Participate in discussions with other course attendees to increase your confidence and proficiency in statistical hypothesis testing. Determine the most robust settings in your process to minimize the different sources of variability.
  • 9 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.
  • 10 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?
  • 11 Request Info

    GMP Requirements for Validation and Re-Validation of Analytical Procedures by Kim Huynh-Ba

    Upon completion of this session, attendees will understand cGMP and ICH validation requirements for analytical procedures and learn key factors that would affect validation process of analytical procedures. It will help scientists develop process for evaluation method validation, review changes, and determine when re-validation would need to take place. It will discuss observations and infractions related to method validation.
  • 12 Request Info

    Webinar: Service Level Agreements (SLAs) - Preparation Guidelines for Effective SLAs by Javier Kuong

    Who Will Benefit: Line senior executives responsible for company operations performance IT and quality assurance professionals Legal counsel officers that help develop agreements and service contracts Purchasing and Procurement Executives Legal Counsel Functions (Internal or External) Corporate and Internal Audit Executives, Internal and Information System Auditors Executives Dependent on Key Support Infrastructure Services, Such as IT and other business services Contingency Planning and Emergency Preparedness Professionals that must specify SLAs CIOs, CFOs, and any C-level Executive that Vitally Dependent on or that oversees Business Services External Auditors and Consultants in Risk Management and Contingency Planning Chief Risk Managers and Chief Security Officers (CSOs) and Professionals Individual Responsible for Negotiating Outsourced Services Compliance and Regulatory Mandate Officers/Professionals
  • 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

    In Search of Quality Series with Robert H. Waterman Jr.

    Bob Waterman takes you on location to two Malcolm Baldrige Award Winners to show quality in Action. Lessons include: Teach employees to gain ownership in the quality program, service, excellence, defect reduction, six sigma, empowerment.
  • 15 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
  • 16 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.
  • 17 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;
  • 18 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.
  • 19 Request Info

    Seminar on Using Statistical Methods for ICH Guidelines

    This hands-on course will provide attendees with an understanding of how to apply statistical methods to the ICH Q series guidelines. The course will deliver tools, templates and insight that will allow participants to immediately begin implementation within their organization/firm. This 2 day hands-on workshop explores the unique challenges facing all facts of a pharmaceutical or biotechnology company. Practical implementation solutions as well as best practice descriptions that will allow management to effectively assess manage and mitigate risk of poorly designed studies. Participants will learn the major aspects of the statistical methods and discover how organizations and external authorities expect organizations to meet these guidelines.
  • 20 Request Info

    Seminar on Using Statistical Methods for ICH Guidelines at Zurich

    This hands-on course will provide attendees with an understanding of how to apply statistical methods to the ICH Q series guidelines. The course will deliver tools, templates and insight that will allow participants to immediately begin implementation within their organization/firm. This 2 day hands-on workshop explores the unique challenges facing all facts of a pharmaceutical or biotechnology company. Practical implementation solutions as well as best practice descriptions that will allow management to effectively assess manage and mitigate risk of poorly designed studies. Participants will learn the major aspects of the statistical methods and discover how organizations and external authorities expect organizations to meet these guidelines. Location: Zurich, Switzerland Venue: Hilton Zurich Airport Venue Address: Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland Registration Link - http://bit.ly/1IMw5SS