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Courses

  • 61 Request Info

    6-Hour Virtual Seminar on SOP Writing, Training and Compliance in the Pharmaceutical Industry

    Overview Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform. Still, it is not widely understood the extent of the commitments we make when we write an SOP or how the writing of the SOP can have a positive or negative impact on training or job performance. For example, there is an expectation that procedures describe the most critical processes for product manufacturing and will be followed consistently, with few if any deviations. In this course you will learn the keys to writing effective SOPs, the vital connection between the documentation and training spheres, and how to maximize this connection to improve the quality of both SOPs and training.
  • 62 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.
  • 63 Request Info

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

    Overview 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.
  • 64 Request Info

    6-Hour Virtual Seminar on Project Management for Non-Project Managers

    Overview This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject. Why you should attend It is not possible to present a complete treatment of project management in the span of 6-hours. It is however, possible to focus in on those most important aspects of project management that are critical to the success of any project. Without basic tools, it is not possible to effectively manage a project to the pre-determined end-date without turmoil and chaos.
  • 65 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.
  • 66 Request Info

    6-Hour Virtual Seminar on A Risk Based Approach To Data Integrity

    This course will provide the attendees with more detailed experience on validation / 21 CFR 11 compliance of a computer system, as well as details for activities associated with computer systems validation. Why you should attend This course is appropriate for beginner and experienced person alike. The topics will build on each other and will give you the latest trends in our heavily regulated industry and how to make it easy for yourself while still achieving data integrity. This is a very hands-on class and the attendees will be given take away templates that will enable them to build a complete package to meet Data Integrity Requirements for Computerized Systems
  • 67 Request Info

    6-Hour Virtual Seminar on Combination Products

    This seminar provides Professionals working in this area with: A thorough understanding of the complexities involved Covers all the relevant regulations and guidelines Gives real life examples of how to register and maintain various types of combination products Interfaces: Change Management and LCM Compliant safety reporting for combination products Documentation requirements and interfacing
  • 68 Request Info

    6-Hour Virtual Seminar on HIPAA Training for Compliance Officer

    This 6-hour seminar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under the Omnibus Rule and any other applicable updates for 2018. Areas also covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to IT. The primary goal is to ensure everyone is well educated on what is myth and what is reality with this law, there is so much misleading information regarding the do's and don'ts with HIPAA - I want to add clarity for compliance officers and what you guys need to do and how to best implement your HIPAA program based on over 18 years of personal experience working with Federal auditors, state auditors, and corporate auditors.
  • 69 Request Info

    6-Hour Virtual Seminar on HR Compliance 101 - for Non HR Managers

    Knowing what to do in employee situations can be difficult for even seasoned Managers and Supervisors, especially if a Supervisor has never had training. For a new Supervisor these problems are intensified. Employee problems easily morph into compliance and legal challenges and often with lighting speed while the Managers and Supervisor is still trying to get a handle on problematic situations. Many have never been trained in even the rudimentary basics of employment law and therefore do not even recognize problem situations until it’s too late.
  • 70 Request Info

    6-Hour Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

    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.
  • 71 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.
  • 72 Request Info

    6-Hour Virtual Seminar on Toxic Work Behaviors Erode the Patient Experience (More Than You May Know!)

    We can no longer stand by and let toxic people erode patient safety, our self-esteem, and the bottom line! This webinar will help you take immediate action! This problem is so severe that Dr. Kusy's research discovered: Only 1-6% of targets of incivility ever filed complaint 94% of leaders reported working with toxic people 92% rated the severity from 7 to 10 on a 10-point scale 45% said the uncivil person lashed out 2-3 times per week 51% of victims said they would likely leave as a result
  • 73 Request Info

    6-Hour Virtual Seminar on SOP Writing, Training and Compliance in the Pharmaceutical Industry

    Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform. Still, it is not widely understood the extent of the commitments we make when we write an SOP or how the writing of the SOP can have a positive or negative impact on training or job performance. For example, there is an expectation that procedures describe the most critical processes for product manufacturing and will be followed consistently, with few if any deviations. In this course you will learn the keys to writing effective SOPs, the vital connection between the documentation and training spheres, and how to maximize this connection to improve the quality of both SOPs and training.
  • 74 Request Info

    6-Hour Virtual Seminar - 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. This webinar will analyze each of these necessary elements of the batch record review process.
  • 75 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.
  • 76 Request Info

    6-Hour Virtual Seminar on Project Management for Non-Project Managers

    This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject. Why you should attend It is not possible to present a complete treatment of project management in the span of 6-hours. It is however, possible to focus in on those most important aspects of project management that are critical to the success of any project. Without basic tools, it is not possible to effectively manage a project to the pre-determined end-date without turmoil and chaos. We have distilled the key aspects of project management into three two-hour virtual seminar segments that will logically move participants from the beginning of the project management process to the end - from initiating the project to closing the project.
  • 77 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. This lesson will be addressing how practice/business managers (or compliance offers) need to ensure their organization is complying with the Federal Substance Abuse and Mental Health Administration (SAMHSA) regulations (42 CFR Part 2) and how this differs from the HIPAA (Health Insurance Portability and Accountability Act) Privacy and Security Regulations. Both regulations carry significant civil and even criminal penalties if not complied with.
  • 78 Request Info

    6-Hour Virtual Seminar on Qualification (IQ, OQ, PQ) and Validation of Laboratory Equipment and Systems for Regulated Industries (Pharma, Biotech, Dev

    This webinar will aim at understanding and scoping out various phases of Qualification activities that will be integrated with the perspectives of Instrument Control, System Suitability Test (SST), Analytical Methods Validation and ensuring Data Integrity for Regulatory Compliance.
  • 79 Request Info

    6-Hour Virtual Seminar on Applying ISO14971 and IEC62304 - A guide to practical Risk Management

    Gaps, incorrect or incomplete implementation of safety functionality can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative. This course will introduce all necessary steps to design, implement and test critical medical devices in a regulatory compliant environment. This course will additionally address the software risk management and the resulting interfaces to device level risk management.
  • 80 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.