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Courses

  • 61 Request Info

    Women's Leadership Certificate Program

    Women at every level of an organization can be strong leaders—bringing essential skills like team leadership, strategic thinking and business acumen to their roles. To flourish as a leader, a woman needs not only the skills to lead, but a dynamic voice that can be heard and followed. This unique 2-day program will provide you with the knowledge and tools to position yourself as a present and future leader, and to speak up and create value for your organization, no matter what your role. You’ll go beyond the fundamentals of communication and assertiveness skills and explore vision, negotiation and strategy—as well as powerful techniques to enable you to find your leadership voice and lead with courage and conviction.

    First, the course will focus on self-awareness and effectively leading yourself. Next, your focus will shift to leading others and presenting yourself as someone who creates and adds value.

    Upon completing this unique course, you’ll receive a special AMA Women’s Leadership Certificate, indicating that you’ve received in-person, hands-on training in leadership areas that are crucial for women who lead in business.

  • 62 Request Info

    Webinar On Complying with Bank Internal Control Requirements of FDICIA and SOX

    Learn history of banking in the US and how to comply with Bank Internal Control Requirements of FDICIA and SOX. Register for the webinar. Price:$150.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/Complying-with-Bank-Internal-Control-Requirements-of-FDICIA-and-SOX-503742/JANUARY-2019-ES-TRAININGREGISTRY
  • 63 Request Info

    Webinar On How to Demonstrate Vendor-CRO-CMO Oversight in the Biopharma and Device Industry

    Learn how to manage CRO-CMO-Vendor used in the Biopharma industry and how to ensure vendor oversight for FDA and EU regulated organizations. Price:$150.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/How-to-Demonstrate-Vendor-CRO-CMO-Oversight-in-the-Biopharma-and-Device-Industry-509016/JANUARY-2019-ES-TRAININGREGISTRY
  • 64 Request Info

    FDA Inspections - Do's and Don'ts 2019

    Overview: In this webinar speaker will define the steps necessary to prepare for an FDA inspection and discuss details surrounding the management of inspections from announcement to close out meeting. Why should you Attend: This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection.
  • 65 Request Info

    Device Changes, FDA Changes, and the 510(k)-2019

    Overview: The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point". This is a major headache. How can companies make that determination? How can they trigger such an analysis over the major change or the series of smaller changes. What approaches are required for product changes; for process changes. How is the process risk-based? How to maximize the process against scarce resources. What are the different considerations for CE-marked product?
  • 66 Request Info

    Theory and Practice of Near-Infrared Spectroscopy

    Overview: NIR is more complex than typical spectroscopic methods. This webinar will compare and contrast NIRS with “commonly used” spectrometers, now in use and more familiar to analysts. Why should you Attend: These can be hand-held, lab-based, or installed in process lines This webinar will explain the manner in which NIR works, the equipment available, and the applications where it may best be used. After this webinar, you will be able to evaluate which type of NIR would be best for your application
  • 67 Request Info

    Trends for Computer System Validation, Medical Device Compliance and FDA Enforcement

    Overview: This webinar will focus on the key areas that are most important for protecting the validity of data that is regulated by FDA, and is typically housed electronically in computer systems. Why should you Attend: This guidance was first issued in 1983, and the main points of focus remain consistent today, despite the number of years that have passed and the technology changes that have taken place.
  • 68 Request Info

    What is Human Factors and why is it Important?

    Overview: This webinar provides a fundamental level appreciation of human factors and how it has been implemented within the engineering discipline to improve design and operation to support system goals. Why should you Attend: Understand the definition and scope of human factors Recognize the benefits of user centred design Identify opportunities where HF may improve current processes and designs Discuss the regulatory environment in several jurisdictions
  • 69 Request Info

    3-Hour Virtual Seminar on FDA's Scrutiny of Social Media Promotion

    Overview: FDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA. Trolling for off-label information in social media, scrutiny of educational material under "safe harbor" and apparent conflicts of interest at a public event create a sink hole for firms even though it may seem innocent in your eyes.
  • 70 Request Info

    OneNote 2016 - Bringing Order to your Digital Chaos

    Overview: For many people the holy grail of organization is a world where email overload doesn't exist and where all those sticky notes and paper notepads are magically replaced by a digital paperless system. Using OneNote, a free application that you will find in the Microsoft Office suite, this dream can become a reality. OneNote is a digital notebook. It is available for Windows, Mac and mobile. Use it to capture, store and organise your ideas and information. OneNote notes can store text, images, videos, embedded files and even drawings and sketches. OneNote notebooks can be shared with colleagues and customers, in fact anyone, making it the perfect platform for collaborative work.
  • 71 Request Info

    Implementing a Robust Data Integrity Program- 2019

    Overview: As regulators are focusing their inspection on data integrity, it is important that managers, supervisors and users in regulated GMP laboratories understand the issues relative to data integrity and implement robust programs to ensure compliance. This webinar will detail a data integrity governance program and principles for defining quality and data integrity into processes and systems. Why should you Attend: Data integrity is defined as the maintenance of, and the assurance of the accuracy and consistency of, data over its entire life-cycle. Data Integrity is a global issue with both FDA and the European Regulatory Agencies majorly focusing on the topic during compliance inspections. Multiple FDA warning letters and EU GMP non-compliance reports have highlighted major data integrity failures and falsification within companies around the globe.
  • 72 Request Info

    The FDA Inspection: Preparation, Management, and Follow - up

    Overview: This is a detailed course designed to provide medical device/pharmaceutical professionals with the information they require to prepare for and manage FDA inspections. This course provides the rationale, strategies and flow on how to plan for an inspection, the inspection process and approach, and which company roles should be assigned for these types of inspections, among other related topics.. Why should you Attend: The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and NOW you're in the spotlight, and if your performance isn't good, it's not the show that may close, it's YOUR COMPANY! However, adequate planning, training, composure, and understanding should result in many encore presentations!
  • 73 Request Info

    Project Management for Non-Project Managers

    Project management is the art and science of getting results by following a roadmap laid down to turn customers desires into concrete products and services by following established procedures in a defined sequence. The Project Management Institute brought active practitioners together to produce the Project Management Body of Knowledge, PMBOK, which is used around the world on all sorts of projects of varying sizes, with or without software support tools. PMBOK definition: A project is a temporary endeavor undertaken to create a unique product or service. It is temporary because every project has a definite beginning and a definite end. It is Unique because the product or service delivered is different from others. Organizations use projects to achieve their strategic needs, which cannot be attained through normal operational means.
  • 74 Request Info

    Onboarding Employees in a GMP Environment: Best Practices for Foundational Employee Success

    The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions. Onboarding new or transferred employees in a Pharmaceutical Good Manufacturing Practices (GMP) environment and ensuring compliance with these requirements create some unique challenges. Although FDA expectations provide some of the framework regarding types and frequency of training, there are decisions that the company will need to make in light of its evaluation of how to best achieve compliance for its employees, maintain a quality culture, and manage the work environment.
  • 75 Request Info

    Better Alternatives to AQL Sampling Plans for Risk Management in Incoming QC

    The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product. The advantages of "confidence/reliability" calculations are explained. Such calculations are demonstrated for Attribute data (pass/fail, yes/no data) as well as for variables data (i.e., measurements). If variables data is "Normally distributed" the calculations are extremely simple. The webinar explains how to handle "non-Normal" data, and provides the methods, formulas, and tools to handle non-normality.
  • 76 Request Info

    EQ and YOU

    Emotional Intelligence is a set of emotional and social skills that establish how well we perceive and express ourselves, develop and maintain social relationships, cope with challenges and engage in life in an effective and meaningful way. Since some of the smartest people I know lack EI (or its measurement on tests EQ) I am sharing several of my observations and experiences with them. One can be brilliant and successful professionally while at the same time struggling to be socially accepted. This course explores several aspects of EI/EQ and offers enough descriptions to enable the listener to self-identify and decide which of the elements needs self-improvement. It is also a useful tool for management in its quest to be as useful as possible to the people who report to them. We explore the different aspects of EQ and how different tests describe and measure them.
  • 77 Request Info

    Utilizing HR Metrics to Illustrate & Improve Human Resource's Contribution

    Human Resource Departments have traditionally been concerned with the processing of transactions and administrative functions - often with little or no objective data to provide them feedback on: The effectiveness of their HR processes Or the contribution that these processes are making to the organization's business strategy However, many senior corporate executives are no longer satisfied with this scenario - they want HR to prove its value and Effectiveness through objective data Human Resources metrics allow HR professionals to: Be seen as business partners who are customer focused, strategic and change oriented Make greater contributions to their business' strategic and operational plans Speak the 'language of business' Gauge whether they are satisfying the needs of their internal customers Make continuous, meaningful improvements to HR processes Show that they are not afraid of measuring their contribution Avoid being outsourced
  • 78 Request Info

    Controlling Human Error in the Manufacturing Floor

    Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences. To work with these challenges it is really important to understand human behavior and the psychology of error as well as understand exactly where the systems weaknesses are, so they can be improved and/or fixed. This course offers practical approaches and models to address human performance issues in GMP related environments by using a specific methodology to correct, prevent and avoid re-occurrence of these issues.
  • 79 Request Info

    Inspiring Leadership through Conflict, Courage, & Creativity: The Art of Passion Power

    In today's diverse, always-on, TNT - Time-Numbers-Technology - Driven & Distracted World, three performance-communication-relationship-building pillars often determine leadership success: Are you courageously developing and passionately projecting your unique energy and experience, strengths and skills? Are you truly "being heard or are you just making noise"? Are you developing mutually productive and innovative partnerships? With the Stress Doc's singular wit and wisdom and Get FIT - FUN-Interactive-Thought-provoking - method, this webinar will strengthen attendees' abilities to bring their own purpose, passion, and power to real work-world issues. You will learn and apply high task & human touch motivational skills and strategies for: high-impact leadership and communication embracing change, loss, and opportunity managing anger and conflict
  • 80 Request Info

    Lean Document Control for Manufacturing in Life Sciences

    Overview This webinar will show you how to implement lean documents and lean document control to cut costs, while maintaining compliance with regulatory authority requirements. Why should you Attend Just as a manufacturing process produces a product, controlled documents are the product of a business process. Just as in manufacturing, a product cannot move forward if it is waiting for component parts, a document cannot move forward if it is waiting for information, or if its use is constrained by other documents. Although many life science companies advocate lean manufacturing, lean laboratory, and lean operations, they have cumbersome controlled documents and systems which cause significant operating expenses, and make it difficult to introduce process