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Courses

  • 1 Request Info

    2-Hour Virtual Seminar on Mastering Excel Pivot Tables

    Overview: You will learn the following in this webinar, The quickest and best ways to create PivotTables and Pivot Charts, including these capabilities: The following subjects will be covered in detail: The following subjects will be covered in detail: How to compare two or more fields in a variety of layout styles How to sort and filter results How to perform ad-hoc grouping of information
  • 2 Request Info

    21 CFR Part 11 - Compliance for Electronic Records and Signatures

    Overview: This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records as described in the FDA Guidance will be explained. FDA regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient safety, wants to prevent electronic records from being compromised with possible resulting harm to the patient. FDA has set up regulations that address both data security and patient safety. We will show how 21 CFR part 11 considers both.
  • 3 Request Info

    21 CFR Part 11 Validation Checklist | Computer Systems Validation

    The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability. FDA's 21 CFR Part 11 was enacted in the late 1990s and implementation success across the pharmaceutical and other regulated industries has been mixed. There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record. keep enhancing: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901300SEMINAR?trainingregistry-January-2018-SEO
  • 4 Request Info

    3-Hour Virtual Seminar - Good Pharmacovigilance Practice

    Refund Policy This course aims to provide basic training for those concerned with pharmacovigilance, This course has been planned to provide you with the essential skills and tools to prepare and host a regulatory inspection and to facilitate the response and follow-up to the inspection outcome, findings (483s) and the necessary Corrective Actions and Preventive Actions (CAPA).
  • 5 Request Info

    3-Hour Virtual Seminar on Data Integrity - FDA's Latest Thinking

    Overview: This webinar will give you the tools that you need to ensure that you understand data integrity issues and best practices for ensuring data integrity at your company. Why should you Attend: The FDA is increasingly focusing on data integrity issues, including data manipulation, when conducting facility inspections. Concerns over data integrity issues have resulted in the agency adding companies to the for-cause inspection list, and the FDA has found questionable data during in a significant number of these for-cause inspections. The FDA is noticing some electronic data manipulation in parts of its inspection program and is focusing on training its investigators to be more alert to data manipulation, Branding said.
  • 6 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.
  • 7 Request Info

    6-Hour Virtual Seminar - Batch Record Review and Product Release

    Overview Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance. A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production and manufacture of pharmaceuticals, biologics, medical devices, etc. This webinar will analyze each of these necessary elements of the batch record review process.
  • 8 Request Info

    6-Hour Virtual Seminar on Batch Record Review and Product Release

    Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance. A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production and manufacture of pharmaceuticals, biologics, medical devices, etc.
  • 9 Request Info

    6-Hour Virtual Seminar on Batch Record Review and Product Release

    Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance. A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production and manufacture of pharmaceuticals, biologics, medical devices, etc.
  • 10 Request Info

    6-Hour Virtual Seminar on Controlling Human Error in the Manufacturing Floor

    Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be 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 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/or fixed.
  • 11 Request Info

    6-Hour Virtual Seminar on Designing Stark Compliant Physician Compensation Models

    This session is designed for health care executives, physicians and other health care providers who participate in and receive remuneration from Medicare, Medicaid, and other federal health care programs such as TriCare. Several recent cases bring home the realization that Stark II (the physician anti-referral law) is alive, still with us and as viable as ever, and it can be used as the basis of a False Claims Act action. As a health care executive, physician or other health care provider, you should be very concerned about the potential for Stark II, as well as the Anti-Kickback Statute, being used as the basis for an action brought under the Federal False Claims Act. In this webinar, you will learn about the elements of the Stark II law, along with the various exceptions and safe harbors that you can rely on for protection against enforcement under this law.
  • 12 Request Info

    6-Hour Virtual Seminar on HIPAA vs. SAMHSA 42 CFR Part 2

    This 6-hour seminar will cover the latest SAMHSA and HIPAA updates which were released in January 2018 and December of 2017 respectively, and also cover multiple scenarios and FAQ’s relating to Substance Abuse Records, Mental Health Records, Alcohol Abuse Records, and the proper ways to secure this information and/or release this information. An overview of a comparative analysis will be presented comparing SAMHSA to the HIPAA laws relating to protected health information in general.
  • 13 Request Info

    6-Hour Virtual Seminar on How to be HIPAA Compliant

    This 6-hour webinar takes the participants through HIPAA compliance from start to compliance. The first presentation explains the history of HIPAA, why it came into being and its evolution. This covers what HIPAA is, what steps have to be performed to be HIPAA compliant and what HIPAA compliance is. It also provides definitions to key HIPAA terms, how to define a Business Associate and how to contract with Business Associates. The second part of the first presentation is an overview of how to manage the HIPAA compliance project. The second session describes what a Risk Assessment is and how to perform the risk assessment. The materials take the participant through the factors of HIPAA compliance and how to perform a HIPAA Risk Assessment.
  • 14 Request Info

    6-Hour Virtual Seminar on Statistical Process Control & Process Capability

    Statistical Process Control charts have been called the Voice of the Process. Progressive manufacturers utilize control charts to "listen" to their processes so that potentially harmful changes will be quickly detected and rectified. However, not all SPC programs deliver to their highest capability as there are many elements to get right to achieve maximum utility. Highly effective SPC programs combine technical competencies, such as using an appropriate chart and sample size for the application, with effective management techniques such as enabling operator buy-in and involvement. This webinar provides a comprehensive introduction to SPC methods and tools to help you deploy an effective SPC program.
  • 15 Request Info

    6-Hour Virtual Seminar on Statistics for Process Control

    This 6-hour virtual seminar includes a presentation of the steps and techniques used to quantify variability in manufacturing processes, and to assure quality products. The concepts and information presented will be mainly concerned with statistical process control: obtaining monitoring information (data) that is objective, unbiased, and useful for decision making. An emphasis will be placed on the set-up and use of control charts.
  • 16 Request Info

    6-Hour Virtual Seminar on Tougher Import Rules for FDA Imports in 2019

    Importing FDA regulated products requires careful planning before you even start. Registration, product compliance, record and data submission must be exactly correct or your product will be detained. Likewise, the U.S. Customs and Border Protection (CBP) must be precise or your entry is not going anywhere. Some mistakes are common, others reflect a lack of understanding of how FDA and Customs and Border Protection (CBP) operate a joint program.
  • 17 Request Info

    A Detailed Introduction on Statistical Process Control

    However, all production processes exhibit variation that is, no two items are identical. What method can be used to reduce such variation? The classic and still most widely used method is called SPC or "statistical process control".
  • 18 Request Info

    A Guide to Building a Safety Culture 2018

    The Behavioral Based Safety system (BBS) is a valued tool used in conjunction with other safety and health aids, such as, job hazard analysis, fault tree analysis, audits, and inspections. The BBS focuses on the behavior of the worker which is measurable and observable, unlike a person's attitude. When behavior which can cause accidents and organizational loses are observed, the BBS system will give aids to the safety officer in coaching safe behavior. The final output of an effective BBS system is to create a safety culture.
  • 19 Request Info

    A Risk Based Approach to IT Infrastructure & Cloud Qualification 2018

    GxP Regulated companies are dependent on validated GxP computerized applications to conduct their day to day operations. These applications are, in turn, depended upon a qualified infrastructure that can be relied upon to provide control and regulatory compliance. The consequences of the IT Infrastructure being out of compliance can result in the failure of an entire site or geographic region being brought to a standstill while the compliance issue is resolved. It can also result in regulatory citations during a regulatory inspection as both the infrastructure be out of compliance and also cause the computerized applications that are dependent on it to be out of compliance.
  • 20 Request Info

    A Risk Based Approach to Testing of Computerized GxP Systems 2017

    Testing is the science of identifying defects, so that they can be corrected, and of demonstrating that a system meets intended requirements. Testing computerized systems is considered a fundamental verification activity and appropriate testing is a regulatory expectation as described in many regulations e.g. EU GMP Annex 11. "Evidence of appropriate testing methods and test scenarios should be demonstrated. Particularly system (process) parameter limits, data limits and error handling should be considered" The regulated company is responsible for demonstrating compliance and fitness for use. Effective testing demonstrates compliance with regulatory requirements and ensures patient safety, product quality and data integrity as a result of controlling identified risks. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901360SEMINAR?trainingregistry-November-2017-SEO