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Courses

  • 1 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
  • 2 Request Info

    Stress Management & Burnout Prevention in the Workplace: Strategies & Solutions

    Overview Professionals are under more stress than ever evidenced by increases in demand for better services that are more efficient and thorough, higher costs, reduced staffing, and diminishing resources. Many workers are putting in longer hours and for less pay. From working overtime to simply burning the midnight oil catching up on paperwork, work industry puts a great deal of stress and fatigue on the average worker and their relationships, including family. Many professionals bear witness to workplace challenges that range from troublesome to traumatic. As a result, high stress and burnout are major hazards of any profession.
  • 3 Request Info

    6-Hour Virtual Seminar - HIPAA - Emailing, Texting, and Personal Devices (myths vs realities)

    Overview This six-hour seminar will be going into great detail regarding you practice or business information technology and how it relates to the HIPAA/HITECH Security Rule and securing PHI in transmission. I will go through multiple examples and specific scenarios and also offer simple common-sense solutions. Areas covered will be texting, email, encryption, medical messaging, voice data, personal devices, and risk factors. I will uncover myths versus reality as it relates to this very enigmatic law based on over 1000 risk assessments performed as well as years of experience in dealing directly with the Office of Civil Rights HIPAA auditors.
  • 4 Request Info

    6-Hour Virtual Seminar on How to be HIPAA Compliant

    Overview 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.
  • 5 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.
  • 6 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
  • 7 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
  • 8 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.
  • 9 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.
  • 10 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
  • 11 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.
  • 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. 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.
  • 13 Request Info

    How to Mitigate Microbials in Purified Water and WFI Water Systems: Theory and Practical Application Details Thoroughly Explained Clearly and Concisel

    This course is a comprehensive training on pharmaceutical water systems encompassing over 15 different course subject and modules. The modules include design, build, installation, validation, regulatory compliance, regulatory audit expectations, documentation expectations, modules on continuous electrodeionization (CEDI), ozone, reverse osmosis (RO), distillation methods, pure steam generation, pretreatment options, microbial mitigation and sanitization methods, raw water and sourced water criteria, instrumentation for both observational and compendial criteria, and automation expectations. Microbial mitigation is one of the most important aspects for purification systems. This course emphasizes the mitigation of microbials in Purified Water and WFI water systems. Profiling microbials in pretreatment systems is a non-compendial exercise.
  • 14 Request Info

    Risk Management in Medical Device Design

    Overview: The webinar will explore the basic principles of risk management and planning as they relate to medical device design and as required by the FDA. It will present a logical process for risk management from risk identification through evaluation/rating and mitigation. Why should you Attend: The secret to preventing medical device recalls or at least to minimizing their impact is sound Risk/Hazard Analysis. Aside from being required, it is absolutely essential and necessary to the development and fielding of medical devices that offer a significant level of protection for patients and manufacturers alike.
  • 15 Request Info

    FDA's New Import Program for 2020

    Overview: The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program require more information from the foreign source(s). FDA's product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. The software coding information must be correct. Otherwise, you face costly delays and possibly a refusal of the entry. In addition, information on the entry's commercial or pro forma invoice must be consistent with the information entered into PREDICT and ACE software. FDA offers some relief from the strict requirements if you participate in a voluntary Affirmation of Compliance (AOC). Providing accurate information is necessary in order to reconcile the PREDICD, ACE, Invoice and AOC information.
  • 16 Request Info

    Webinar on Understand the Validation of Compressed Air Systems

    This course will discuss potential contamination types in pharmaceutical compressed air systems and how to prevent them. Price:$229.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link - https://www.onlinecompliancepanel.com/webinar/Validation-of-Pharmaceutical-Compressed-Gasses-504645/NOVEMBER-2019-ES-TRAININGREGISTRY
  • 17 Request Info

    eCTD Submissions of IND-NDA to the US FDA, EU and Canada

    The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies. Reformatting for multiple submissions is substantially limited. The CTD has improved the regulatory review processes and enabled implementation of good review practices. The eCTD has increased efficiency for reviewers and improved submission times. Beginning in May 2017, the eCTD will be required in the US for all marketing applications.
  • 18 Request Info

    Leadership and Team Development for Managerial Success

    Inspire and influence your team members to achieve your goals as a team! Managers who will be promoted are the ones who not only manage efficiently but also lead their teams effectively. Learn how to work in a horizontal mode of operation…apply a consistent theory in leading your team…and teach critical leadership skills to members of your team, so each and every one of them can lead the team in your absence.
  • 19 Request Info

    6-Hour Virtual Seminar on Transition from Peer to Supervisor

    Today's workforce is experiencing high turnover and disengaged employees. It is a known fact that employees quit managers- to avoid turnover it is critical to have the appropriate skills to retain employees. Transition from a Peer to Supervisor can be very difficult for most newly promoted supervisors. Many are not equip with the tools to successfully transition. This seminar will equip newly promoted supervisor with tools and techniques to decrease turnover, increase employee engagement and increase employee productivity.
  • 20 Request Info

    6-Hour Virtual Seminar on Clinical Data Management - Part II

    When new drugs or devices are tested in humans, the data generated by, and related to, these trials are known as clinical data. This data represents a huge investment by the biopharmaceutical or device company and is one of its greatest assets. It is this data that will eventually make a new product both useful as a treatment or therapy and marketable. The management of clinical data, from its collection during a trial to its extraction for analysis, has become a critical element in the steps to prepare a regulatory submission and to obtain approval to market a treatment. As its importance has grown, clinical data management (CDM) has changed from an essentially clerical task in the late 1970s and early 1980s to the highly computerized specialty it is today.