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Courses

  • 181 Request Info

    Time-Saving Excel Tips, Tricks and 100 Shortcuts

    Overview: Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user. Whether it's a keystroke shortcut or a hidden command sequence, such shortcuts can make you much more proficient and productive as you use this powerful and popular software. Most users are under-utilizing Excel and could be saving minutes every day and hours every week if they learn some of the many tips presented in this fast-paced webinar. In these days of tight budgets and hiring freezes, its' all the more important for you to use your existing software more efficiently. This webinar will give you the productivity boost you need as you become a more proficient Excel user.
  • 182 Request Info

    3-Hour Virtual Seminar on CAPA for Medical Devices

    Overview: CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, and ineffective CAPA process. Not only do they fail to achieve necessary improvements, they waste precious time and resources. This 3-hour webinar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. Learn how to avoid common problems and establish an efficient and effective CAPA process leading to improved quality and compliance for your company.
  • 183 Request Info

    The Value of a Human Factors Program

    Why should you Attend: This year FDA published their priority list for the completion of their Guidance documentation. This annual activity gives us inspection and enforcement insight into the priorities within the agency. Interoperability and Cybersecurity were in the top 3. The implementation of a robust HF program will include both of these disciplines. Following the implementation of the results of a Human Factors/ Usability study, a validation of the safety and effectiveness of the use of the device must be conducted. This webinar will help to sort through the confusion of the standard and help meet regulatory expectations by enumerating the tasks necessary to build a robust Risk based HF program.
  • 184 Request Info

    AQL Sampling Plans for Risk Management in Incoming QC

    Overview: 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.
  • 185 Request Info

    Best Practices for Foundational Employee Success

    Overview: 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.
  • 186 Request Info

    Quality is not an Organization

    Overview: What does Quality mean to you? Is it a noun meaning an attribute or characteristic measured against a standard or customer requirement? Is it a state of product being free from defects? Is it an organization within your company that is responsible for creating inspection standards or a quality system? Or is it something more? It can be something more powerful for your company. It can be a culture of excellence and a management philosophy leading to improved customer satisfaction and business success.
  • 187 Request Info

    Software Validation for the New FDA Inspections

    Overview: This course will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described. This course is NOT a programming course. We will discuss what must be done but will not discuss methods to execute necessary testing.
  • 188 Request Info

    Verification vs Validation-Product, Process or Equipment

    Overview: The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.This webinar will address the use of the FDA, GAMP, 21 CFR Part 11,"Electronic Records"/"Electronic Signatures", IEC 62304, and other applicable industry software validation models, coupled with the ISO 14971/ICH Q9 Product Risk Management models, to plan, structure, run, and document acceptable software validations. The FDA and other regulatory agencies have stated that software validation can only be accomplished effectively if "risk-based". How can this be done in the "real-world".
  • 189 Request Info

    Excel Spreadsheets in FDA Regulated Environments

    Overview: Excel Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation. Regulations such as HIPAA, Sarbanes Oxley Act and FDA's GxP and 21 CFR Part 11 require users of software and computer systems to demonstrate and document data accuracy, integrity and confidentiality. Out-of-the box Excel® has not been designed for regulated environments. However, with a good knowledge of Excel® capabilities combined with good procedures and practices on how to validate and use Excel® requirements can be met. For example, the FDA is widely using Excel® and complies with its own regulations.
  • 190 Request Info

    Excel Formulas and Functions in Advanced

    Overview: Built in to Excel are over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel. This session gives you perspective on what functions are available and explains (with extensive examples) how to use many of them, including: the IF function (with AND and OR), the powerful VLOOKUP function, selected Date, Statistical, Financial, and Mathematical functions, and the frequently overlooked Text functions. In addition, the powerful COUNTIF/SUMIF family of functions, as well as more recently introduced functions are also covered.
  • 191 Request Info

    3-Hour Virtual Seminar on the Human Error Tool Box

    Overview: This course provides a practical approach that will allow you to understand human behavior in the workplace, to assess your current human reliability situation, and support human error reduction efforts at your site. Based on a scientific methodology that assures repeatability and uniformity, the tools presented here will guide you through the process that will guarantee fast but sustainable human error reduction. The use of these tools have proven to be effective, and since our system is data driven you will be able to support recommendations, decisions, projects, and course of action.
  • 192 Request Info

    Annual ACH Rules Compliance Audit a Step-by-Step Guide

    Overview: The NACHA Operating Rules and Guidelines require that all participating depository financial institutions, third-party senders and third-party service providers that provide ACH services conduct an annual ACH audit to be performed by December 31 of each year (ACH Rules, Article 1). With the requirement that each participant conducts an annual ACH audit, this helps to ensure that electronic payments work safely and efficiently for all users. Why should you Attend: Due to a recently approved amendment to the NACHA Operating Rules, Appendix 8 has been removed from the Rules (Appendix 8 was the "guide" or checklist while completing the annual ACH Audit).
  • 193 Request Info

    Overcoming Obstacles of the Canadian Drug Regulatory Landscape

    Overview: Learn what common obstacles are in the Canadian Drug Development and Approval Process and how to avoid them or manage them efficiently should they occur. We will discuss each obstacle in detail and deliver tips that will improve your efficiency and increase opportunities for successful market access. Through this presentation, you will develop a comprehensive understanding of the Drug Approval Process and in parallel examine major misconceptions and misunderstandings.
  • 194 Request Info

    How to conduct a Compliance Gap Analysis for ERM

    Overview: This webinar will explain how to conduct a compliance gap analysis for Enterprise Risk Management (ERM). Attendees will learn best practices to ensure ERM compliance. Why should you Attend: Areas of Enterprise Risk Management include: business continuity, disaster recovery, cyber security, information security, emergency management and crisis management. If you are responsible for one of the enterprise risk areas and are not ensuring that the company is compliant, you may be held liable by your corporation.
  • 195 Request Info

    FDAs Quality Metrics - Latest Advances

    Overview: This presentation has been created directly from FDA material, using slides from FDA presentations, both internally to the FDA and to the industry at large. Comments from FDA and industry experts have been captured as well, to provide context and deeper understanding for the trainee. Why should you Attend: This is a very important initiative for the FDA who is planning to use the quality metrics as part of their risk based inspection process. Consequently, putting the quality metrics program in place may reduce the inspection frequency at your facility.
  • 196 Request Info

    Third-Party Sender Registration - Are you in Compliance?

    Overview: The ODFI is responsible for the registration process for any Third-Party Senders and nested TPS; registration is also necessary even if there is no TPS relationship. Why should you Attend: The registration process will promote consistent customer due diligence among all ODFIs, and serve as a tool to support NACHA's continuing efforts to maintain ACH Network quality.
  • 197 Request Info

    How to Create a Medical Software Development File - ISO 62304

    Overview: This course will give an introduction how to develop medical software under the requirements of the ISO 62304 and how to apply these in a medical software development project and how a smart application during the medical software development and in the post market process is possible. Further the risk management of medical software development. In the European Union is the application of the ISO 62304 for medical software mandatory and part of the essential requirements of the medical device regulation. In the technical documentation is required to approve the development process and the life cycle of medical software according ISO 62304.
  • 198 Request Info

    Architect and Implement Solution 2019

    Overview: Learn to properly prepare for an impact to the business for any organization. We will cover how to identify, analyze and document the events and environmental surroundings that can adversely affect the organization. You will learn how to both prepare and review the continuity planning program. Areas such as IT Outsourcing and other risks will be covered. It is critical to assess the IT and Information Security risks and the effectiveness of the institution's risk management processes as they relate to the security measures.
  • 199 Request Info

    Statistical Hypothesis Tests: Concepts and Applications

    Overview: This training program will cover statistical hypothesis testing concepts including: null and alternate hypotheses, test statistics, p-values, confidence intervals, confidence levels, power, power curves, and sample sizes. Several types of hypothesis tests will be covered such as 1 and 2-sample means tests, tests of variances, and tests of proportions. Equivalence tests will also be discussed. The importance of selecting appropriate sample sizes will be stressed.
  • 200 Request Info

    Quality Control for Microbiological Media and Reagents

    Overview: This webinar will help you develop a quality control program that fits your microbiological laboratory's needs. We will explicitly not cover any serological, immunological or molecular tests. Why should you Attend: In microbiology laboratories, there are a wide array and media for all sorts of use. From clinical laboratories, to environmental monitoring, from research laboratories to industrial labs, there are a large number of different set-ups. These media and reagents need to be monitored on a regular basis to ensure that the work performed in these laboratories is accurate and true. Otherwise, false results will be reported, which can lead to serious consequences and harm the public health in a myriad of ways.