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Courses

  • 1 Request Info

    PCAOB Auditing Standard 1300: Auditor Communications - 2 CPEs

    This training event covers the two different subsections of the PCAOB Auditing Standard 1300. PCAOB Auditing Standard 1301: Communications with Audit Committees requires the auditor to communicate with the company's audit committee regarding certain matters related to the conduct of an audit and to obtain certain information from the audit committee relevant to the audit. PCAOB Auditing Standard 1305: Communications About Control Deficiencies in an Audit of Financial Statements covers the communication requirements in financial statement audits to identify deficiencies in the company's internal control over financial reporting and report these to the Audit Committee and management prior to the issuance of the auditor's report on the financial statements. This timely, two hour morning CPE training event is designed for the CPA firm staff members who will be working on PCAOB regulated audits. The attendees will learn how this PCAOB Auditing Standard should be reflected in the auditing
  • 2 Request Info

    Microsoft Power BI

    A course designed to teach end users how to use Microsoft Power BI, interactive dash boards, data visualization, and how to use Power BI engine to convert Excel and many other data sets into useful data. It will also show you how to use the Microsoft Excel Power Query Editor in conjunction with Power BI. You will learn how Excel can function like a Database.
  • 3 Request Info

    Developing Cultural Diversity

    A course designed to assist Human Resources, and employees, to understand how the changing dynamic in the 21st century workplace, lends itself to understanding Cultural Diversity, And learning how to Develop Cultural Diversity. It will break down Micro-Aggressions, and Difficult Conversations, that can lead to Cultural destabilizations.
  • 4 Request Info

    Certificate in Diversity and Inclusion in HR Management

    This online course suite, Certificate in Diversity and Inclusion, is designed for human resources managers to learn how to create and assess diversity and inclusion programs to make their company compliant and profitable.
  • 5 Request Info

    Performance Management - Doing It Right Could Be Your Competitive Advantage

    Overview: The one and only purpose of a performance appraisal is to "IMPROVE FUTURE PERFORMANCE." The only competitive advantage any organization has is its employees. So while your competitors are either doing away with giving meaningful feedback to their employees or using it to recount history, It is a perfect time for you to energize your employees with meaningful work and gain their commitment to the job and to you, their supervisor.
  • 6 Request Info

    Dealing with Difficult People

    Overview: Sounds pretty simple, doesn't it? When you do it right, Dealing With Difficult People drastically improves your life as you improve your working relationships with people who challenge you to the limits of your patience (yes, even the ones who make you tear your hair out - literally!). What will Dealing With Difficult People do for you? It will: Give you back control. As you gain new strategies and techniques for maintaining composure during difficult circumstances, you'll drop the victim role and take control, which means a huge improvement in individual situations as well as your entire working environment Give you the tools you need. You'll have an easy-to-follow strategy you can use in any situation - designed to be realistic solutions to real problems you face in the workplace and at home Give you immediate actions to take. Alleviate the stress and tension you've been experiencing by taking concrete actions, right away, to take control
  • 7 Request Info

    Terminating Employees Safely

    Overview: The risks of a former employee filing discrimination charge increases significantly after they are terminated involuntarily. It is hard to find information on how many discrimination charges are as a result of terminating employees (as opposed to hiring, discipline or other reasons), but in my 42 years of dealing with Human Resources issues, I would say the percentage is more than 95%. Therefore, it is very important that a termination be handled well. There are a number of steps that should be followed when having a termination discussion with an employee. Following the steps in this webinar will greatly minimize your risks of being charged with discrimination when you have to terminate an employee.
  • 8 Request Info

    Performance Reviews Remotely: A Step-By-Step Process For Conducting Them Meaningfully and Effectively

    Overview: One of the most critical areas of employee relationships and one of the biggest challenges management faces today is conducting effective performance appraisals and determining appropriate merit increases. Learn to give performance appraisals that help motivate employees to achieve goals and increase their value to the organization. Since both managers and employees often view performance appraisals with anxiety, attention is given to preparing for and conducting performance discussions that are objective, complete and defensible. You'll also share experiences and participate in various exercises with other participants to better understand how to obtain the best possible performance from employees.
  • 9 Request Info

    Moving from an Operational Manager to a Strategic Leader

    Overview: Gain the insights and skills to know where your business stands today and where it's heading tomorrow. In today's unpredictable business environment, strategic leadership is not just for top management alone. It's for: Managers who want to increase their competitive advantage by anticipating their customers' priorities, needs and expectations Managers who want to distinguish operational data from strategic data, creatively develop sources of information and increase their staffs' flexibility and responsiveness Managers who want to broaden their perspective, improve flexibility without compromising quality and increase their department's value to the organization Every manager who wants to anticipate, initiate and manage change for maximum competitiveness!
  • 10 Request Info

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

    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".
  • 11 Request Info

    GMP Environmental Monitoring for Pharmaceutical Clean Rooms

    Overview: Environmental Monitoring looks at the end results of the Environmental Control program - the microbiological and particulate quality of the clean room. As the FDA Guideline on Aseptic Processing GMP (2004) states: "In aseptic processing, one of the most important laboratory controls is the environmental monitoring program. This program provides meaningful information on the quality of the aseptic processing environment (e.g., when a given batch is being manufactured) as well as environmental trends of ancillary clean areas. Environmental monitoring should promptly identify potential routes of contamination, allowing for implementation of corrections before product contamination occurs." Therefore, ongoing environmental monitoring of a clean room environment is necessary to assure the quality and safety of the pharmaceutical product.
  • 12 Request Info

    Using Statistics to Determine Sample Size

    Overview: We often sample from a process or population in order to make an inference about the process based on the sample results. Selecting appropriate sample sizes often vexes many practitioners. This webinar discusses many issues present in any sample size determination. The webinar also discusses several common applications that require an appropriate sample size determination including estimation of product/process performance characteristics, hypothesis tests, acceptance sampling, Statistical Process Control charts, and reliability demonstration. When selecting sample sizes, it is important to align the statistical properties of the estimate or test with practical considerations. More data is not always better. Numerous examples are provided to illustrate the key concepts and applications.
  • 13 Request Info

    Human Error Reduction Techniques for Floor Supervisors

    Overview: Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar. People make mistakes because they can; our systems allow it. To work with these challenges, it is essential to understand human behavior and the psychology of error as well as understand exactly where the weaknesses of the system are so that they can be improved and fixed. This course offers practical approaches for supervision on the floor, strategies to get your group in sync and approach issues in GMP related environments by using a specific methodology to correct, prevent and avoid re-occurrence of these issues.
  • 14 Request Info

    CAPA: Corrective and Preventative Actions and Non-Conformances

    Overview: If, instead, you look deeper to figure out why the non-conformance is occurring, you can fix the underlying systems and processes that caused it. Root Cause Analysis (RCA) is a popular and often-used technique that helps people answer the question of why the non-conformance occurred in the first place.
  • 15 Request Info

    6-Hour Virtual Seminar on Applied Statistics, with Emphasis on Risk Management in R&D, QA/QC, and Manufacturing

    The Virtual Seminar explains how to apply statistics to manage risks and verify/validate processes in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry. The flow of topics over the 6 hours is as follows: ISO standards and FDA/MDD regulations regarding the use of statistics Basic vocabulary and concepts, including distributions such as binomial, hypergeometric, and Normal, and transformations into Normality Statistical Process Control Statistical methods for Design Verification Statistical methods for Product/Process Qualification Metrology: the statistical analysis of measurement uncertainty, and how it is used to establish QC specifications How to craft "statistically valid conclusion statements" (e.g., for reports) Summary recommendations
  • 16 Request Info

    6-Hour Virtual Seminar on Understanding the New USP Chapter 1224 for Transfer of Analytical Methods

    When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory. So far there has not been an official guidance on what exactly is expected to maintain 'the validated state'. Now the USP has published a proposal for a general chapter <1224>. Also the FDA has released an official guidance on how to conduct and document method transfer. The new USP chapter will become official with USP 35. Now it is a good time to learn how to conduct and document method transfer. This seminar will give a good understanding of USP and FDA requirement and provide recommendations and tools for effective implementation.
  • 17 Request Info

    6-Hour Virtual Seminar on The EU Clinical Trial Regulation - EU Filings & Registrations

    This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics). The course also covers recent updates on EU-GCP associated with the new regulatory framework and highlights of the new EU Pharmacovigilance Directive, as it relates to studies and helpful tips into working with the European regulators. The webinar covers the impending changes coming with the EU Parliament passage of the EU Clinical Trial Regulation, which will affect all trials conducted across the EU [new and ongoing].
  • 18 Request Info

    6-Hour virtual Seminar on Evolution of the Quality Management System - How to go from Surviving to Thriving

    This 6 -hour virtual seminar will help you to develop a Quality Management System (QMS) for Medical Device Companies. A well-structured QMS meets the requirements of the Quality System Regulations and is both effective and efficient. The regulations require that manufacturers "establish and maintain a quality system that is appropriate for the specific medical device(s) designed and manufactured".
  • 19 Request Info

    Leadership Skills Training Courses

    In the Academy of Business Training Leadership Skills Training courses, working professionals will learn the administration of their area of responsibility within an organization, whether it is a business, a not-for-profit organization, or government body. Students will learn to set the strategy of their area of responsibility and to coordinate the efforts of its employees (or of volunteers) to accomplish its objectives through the application of available resources, such as financial, natural, technological, and human. Students will learn to identify the mission, objectives, procedures, rules, and management of the human resources of the organization to contribute to the success of the organization. Students will also learn effective communication, motivation, and successful progress or system outcomes.
  • 20 Request Info

    HIPAA 2021 - Upcoming Changes

    Overview: This 90-minute webinar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order as HIPAA HITECH is now fully enforced with bipartisan support and the government is not using kid gloves any more. It will also address major changes under the Omnibus Rule, Trump (or Biden) administration, new congressional mandates and any other applicable updates for 2021 and beyond along with changes relating to COVID19 and Information Blocking under the Cures Act (do’s and don’ts). There are an enormous amount of issues and risks for covered entities and business associates these days – we will speak to the most common violations and fines – and how to best avoid fines and headaches.