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Courses

  • 1 Request Info

    2-day In-person Seminar 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
  • 2 Request Info

    2-Hour Virtual Seminar on Physician Employment Agreements, Contractor Agreements & Legally Compliant Compensation Models

    This webinar discusses the selection and employment contracting process that follows the identification of a suitable opportunity, You should attend this webinar to gain an understanding of what should and what should not be in a physician employment agreement, However, the agreement serves to protect against future disputes.
  • 3 Request Info

    2-Hour Virtual Seminar on Valid Statistical Rationales for Sample Sizes

    This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size. The statistical methods discussed during the webinar include the following: Confidence intervals Process Control Charts Process Capability Indices Confidence / Reliability Calculations MTBF Studies ("Mean Time Between Failures" of electronic equipment) QC Sampling Plans
  • 4 Request Info

    2017 HIPAA Changes

    This lesson will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order as HIPAA is now fully enforced and the government is not using kid gloves any more. It will also address major changes under the Omnibus Rule, Trump administration, and any other applicable updates for 2017 and beyond.
  • 5 Request Info

    2018 Webinar on Problems with Aging Physicians

    Overview: Practicing medicine is not like other jobs that have a tradition of retirement at age 65. Physician shortages fuel support for physicians seeking to continue their careers indefinitely. Patient safety is paramount, but is it served by applying an age limit to medical staff membership and clinical privileges? If so, what is the magic number? Why should you Attend: Can medical staffs and hospitals place restrictions on physicians based on age? Should hospitals and medical staffs place restrictions on physicians based on age? Can physicians sue, alleging discrimination and civil rights violations? Areas Covered in the Session: Age Restrictions on Medical Staff membership and clinical privileges State Laws affecting physician age restrictions Federal laws affecting physician age restrictions Accreditation requirements related to age-based credentialing Implementation of age-based screening Eligibility for peer review protection
  • 6 Request Info

    2019 update on Compliance with the Americans with Disabilities Act: Understanding Disability Rights

    Overview The Americans with Disabilities Act (ADA) was signed into law by George H.W. Bush in July 1990. The Act is a civil rights law that prohibits discrimination against individuals with disabilities in all areas of public life, including jobs, schools, transportation, and all public and private places that are open to the general public. The purpose of the law is to ensure that people with disabilities have the same rights and opportunities similar to those provided to individuals on the basis of race, color, sex, national origin, age, and religion.
  • 7 Request Info

    21 CFR Part 11 Compliance Checklist- FDA Software Validation

    This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Many companies are outsourcing IT resources and getting involved with Software as a Service (SaaS) and cloud computing. These vendors are not regulated and therefore regulated companies must ensure compliance for both infrastructure qualification and computer system validation. It is the regulated company that wants to avoid FDA form 483s and warning letters. The seminar is intended for regulated companies, software vendors, and SaaS/Cloud providers. The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901525SEMINAR?trainingregistry-March-2018-SEO
  • 8 Request Info

    21 CFR Part 11 Compliance for Computer Systems Regulated by FDA 2017

    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. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901297SEMINAR?trainingregistry-November-2017-SEO
  • 9 Request Info

    21 CFR Part 11 compliance for software validation and SaaS/Cloud

    Overview: • This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. • Many companies are outsourcing IT resources and getting involved with Software as a Service (SaaS) and cloud computing. These vendors are not regulated and therefore regulated companies must ensure compliance for both infrastructure qualification and computer system validation. It is the regulated company that wants to avoid FDA form 483s and warning letters. The seminar is intended for regulated companies, software vendors, and SaaS/Cloud providers.
  • 10 Request Info

    21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures

    Overview: 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.
  • 11 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
  • 12 Request Info

    3-Hour Virtual Seminar on HIPAA Compliance for 2019 - Clear, Complete, Step-by Step

    In this Online Training program Speaker will explain how Covered Entities and Business Associates can comply calmly, confidently and completely with the HIPAA Rules.
  • 13 Request Info

    3-Hour Virtual Seminar on HIPAA Texting and E-mailing

    Overview: This lesson 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. I will speak on specific experiences from over 17 years of experience in working as an outsourced compliance auditor, expert witness on multiple HIPAA cases in state law, and thoroughly explain how patients are now able to get cash remedies for wrongful disclosures of private health information.
  • 14 Request Info

    3-Hour Virtual Seminar on HIPAA Training for Compliance Officer

    This webinar will address major changes under the Omnibus Rule and any other applicable updates for 2019.
  • 15 Request Info

    3-Hour Virtual Seminar on Patient Communications, E-mail, and Texting

    This session will describe the information security compliance process, how it works, and how it can help you decide how to integrate e-mail and texting into your organization in a compliant way, learn how to use an information security management process to evaluate risks and make decisions about how best to protect PHI and meet patient needs and desires.
  • 16 Request Info

    3-Hour Virtual Seminar on The Interface Between Medicare and Medicaid, Anti-kickback Statute (AKS), Stark II and the Federal Civil False Claims Act (F

    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.
  • 17 Request Info

    483 Covers a Broad Gradation of Problems

    The FDA list of inspectional observations (aka 483) tells the FDA the kinds of deviations a firm has and how serious they are. The 483 and the inspection report provide the factual foundation for the FDA to determine whether official action is appropriate. Ideally you will not receive a 483, which for the moment indicates you appear to be in substantial compliance.
  • 18 Request Info

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

    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.
  • 19 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.
  • 20 Request Info

    6-Hour Virtual Seminar on HIPAA 2019 - Staying Competitive and Complying with HIPAA

    In today's competitive business climate, health care organizations and their business associates should be able to focus on growing their businesses and not worrying about HIPAA Compliance. Staying up to date on the newest health care information and acquiring new patients takes time. HIPAA compliance takes time. But both goals can be accomplished - in fact, a good compliance program can make you even more competitive because compliance helps protect and grow your business and sets you apart from your competitors. For example, knowing how to use social media and electronic communications within HIPAA rules is key to staying competitive.