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Courses

  • 1 Request Info

    How Will FDA's New Approach to CSV Make Implementations Easier?

    Advancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges.
  • 2 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
  • 3 Request Info

    6-Hour Virtual Seminar on Combination Products

    Overview 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
  • 4 Request Info

    3-Hour Virtual Seminar on The Interface Between Medicare and Medicaid

    Overview: Recent cases and/or enforcement actions involving the Federal Civil False Claims Act (FCA) as well as the Medicare-Medicaid Anti-Kickback Statute (AKS) and/or Federal Physician Self Referral Law (Stark II) raise serious concerns regarding compliance issues with the hospital, physician practices, and other healthcare entities. Recoveries under the FCA are at an all-time high, and the percentage of actions involving healthcare organizations has been increasing at exponential rates. Why you should Attend: 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.
  • 5 Request Info

    6-Hour Virtual Seminar on Biostatistics for the Non-Statistician

    Statistics is a useful decision making tool in the clinical research arena. When working in a field where a p-value can determine the next steps on development of a drug or procedure, it is imperative that decision makers understand the theory and application of statistics.
  • 6 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
  • 7 Request Info

    Key Elements in Managing and Maintaining Your Credit Administration and Credit Policy

    Overview: This session by Dev Strischek is intended to provide guidance on how to develop and maintain a Credit Administration (CA) function that will provide guidance to anyone involved in the credit function of the bank. The session also highlights the safeguards to manage the bank's loan portfolio in a safe and sound manner.
  • 8 Request Info

    Medical Device Hazard analysis following ISO 14971

    Overview: The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA also expects a post production risk management program be implemented. FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard.
  • 9 Request Info

    Expedite Excel with Hidden Shortcuts

    Overview: Excel expert David Ringstrom, CPA is fond of stating "Either you work Excel, or it works you!" In this fast-paced presentation David will share over two dozen ways that you can reclaim part of your day from Excel. You'll uncover mouse techniques, keyboard shortcuts, hidden menus, and even ways to create your own custom keyboard shortcuts in Excel. Restore the classic print preview screen in Excel 2010 and later, undo or redo multiple actions at once, and even learn how to have Excel read words and numbers aloud to you. There's even a shortcut for toggling the Locked property of worksheet cells that you want to protect or unprotect. David will teach from primarily from Excel 2010, but will demonstrate new features in Excel 2013 when warranted, as well as disclose any differences in Excel 2007. Coverage of Excel 2003 will be limited to questions raised by the audience.
  • 10 Request Info

    Hazardous Material Release Reporting Requirements

    Overview: Hazardous materials pose a danger to the environment. Federal regulations require immediate reporting to specific agencies (federal and local) in the event of a release to the environment. We will cover the diferrent requirements, how to determine if you are required to report a release, and strategies to implement proactive actions to minimize the likelihood of a release, and you internal response time to avoid or minimize any potential enforcement actions.
  • 11 Request Info

    Spill Prevention Control and Countermeasures (SPCC) Inspection Requirements

    Overview: The inspection requirements of the SPCC rule are designed to detect oil leaks, spills, or other potential integrity or structural issues before they can result in a discharge of oil to navigable waters of the U.S. or adjoining shorelines. Regularly scheduled inspections, evaluations, and testing of bulk oil storage containers by qualified personnel are critical parts of discharge prevention. A container integrity inspection and/or testing program may involve one or more of the following: an external visual inspection of containers, foundations, and supports; non-destructive testing (examination) to evaluate integrity of certain containers; and additional evaluations, as needed, to assess the containers' fitness for continued service.
  • 12 Request Info

    Personal Protective Equipment Requirements

    Overview: Personal protective equipment, commonly referred to as "PPE", is equipment worn to minimize exposure to hazards that cause serious workplace injuries and illnesses. These injuries and illnesses may result from contact with chemical, radiological, physical, electrical, mechanical, or other workplace hazards. Personal protective equipment may include items such as gloves, safety glasses and shoes, earplugs or muffs, hard hats, respirators, or coveralls, vests and full body suits.
  • 13 Request Info

    Laboratory Safety Requirements

    Overview: The Occupational Exposure to Hazardous Chemicals in Laboratories standard (29 CFR 1910.1450), commonly referred to as the Laboratory standard, requires that the employer designate a Chemical Hygiene Officer and have a written Chemical Hygiene Plan (CHP), and actively verify that it remains effective.
  • 14 Request Info

    Mastering Excel Pivot Tables

    Overview: PivotTable capabilities are enormous; among its many tools and features. 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: 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 How to use Slicers instead of filters to identify which field elements are displayed How to drill down to see the details behind the summary How to categorize date/time data in multiple levels How to create a Pivot Chart that is in sync with a PivotTable
  • 15 Request Info

    Digital Marketing for Healthcare - Connecting Audience to Industry Online

    Overview: A brief review of the HIPAA Rules that apply to websites and social media platforms for the Healthcare industry. Simple principles for maintaining compliant websites and social media accounts. Fundamentals of marketing: SEO, messaging, continuity Education on how to find the right experts for creating or improve a healthcare website, including functionality and design.
  • 16 Request Info

    Physician Compensation Update: What Providers Need to Know

    Overview: In this session Mr. Wolfe will provide an overview of key developments in physician compensation in 2020. Why you should Attend: It has been a whirlwind year for physician compensation in the U.S. Since last year, the government has issued new proposed Stark and Anti-Kickback rules, declared a public health emergency, paused elective procedures and issued Stark blanket waivers to assist providers in their response to the pandemic.
  • 17 Request Info

    Life Centered Therapy: Live Demonstration

    Overview Life Centered Therapy is a psychospiritual, mindbody, energetic framework for healing/transformation. Find and transform through your body the story that you are unconsciously re-membering through physical, emotional, mental, relational, and/or spiritual difficulties. Resolve symptoms; enhance choice; discover soul/life lessons. Overview and demonstration. To return to wholeness seven steps may be necessary: 1) knowing our passion/destiny 2) releasing obstacles 3) developing mastery and discipline 4) creating more energy 5) developing maturity - moving from a polarized to an incorporative perspective 6) acknowledging every perspective and opening to its value 7) experiencing that we are the consciousness of life itself. In this introductory talk/demonstration we will particularly focus on the second step.
  • 18 Request Info

    6-Hour Virtual Seminar on The Use of Drug Master Files & Quality Agreements: Understanding and Meeting your Regulatory and Processing Responsibilities

    This combined DMF (Drug Master Files) and Quality Agreement training will discuss the advantages for suppliers and drug product manufacturers in developing these arrangements together. Over time, there have been several misunderstandings between supplier / contractors and pharmaceutical / biologic finished product manufacturers. The root of many of the problems lie in a lack of a suitable agreement delineating roles, responsibilities and resolution to agreement to these issues. Part of these arrangements typically involve the development, support and updating of confidential technical files (Drug Master files), which allow suppliers to protect their confidential product and process information from each and every customer and share it only with the Agency.
  • 19 Request Info

    6-Hour Virtual Seminar on 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.
  • 20 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.