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Courses

  • 21 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.
  • 22 Request Info

    6-Hour Virtual Seminar on SAMHSA 42 CFR Part 2 vs HIPAA - How to Apply Recent Changes

    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.
  • 23 Request Info

    6-Hour Virtual Seminar on The Interplay of the Americans With Disabilities Act

    Legal compliance can get confusing when some legal regulations seemingly overlap or even seem almost contradictory to implement. This is the case when the Americans with Disabilities Act (ADA), the Family and Medical Leave Act (FMLA), and Workers’ Compensation intersect. The intersecting of these three laws is complicated and open to problems if not handled correctly. ADA, FMLA and Workers Compensation have different goals and protections for employees, yet all three have provisions that may require an employer to give job-protected time off when the right circumstances are met.
  • 24 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
  • 25 Request Info

    Advanced PDF Techniques: Taking PDFs to the Next Level

    Overview This topic helps business professionals understand the various PDF applications on the market and what factors to consider when choosing a PDF application. This material also provides specific tips and tricks for creating the type of PDF you need in specific situations and how to work with PDFs created by you or by others.
  • 26 Request Info

    AML High-risk Transactions - Identify, Manage, Resolve

    This webinar will discuss the techniques for controlling and managing High Risk Transaction. The Instructor will discuss the parameters for identifying and qualifying transactions as high risk and process and communication to be followed. He will also discuss how to resolve the end result.
  • 27 Request Info

    Analytical Instrument Qualification and Validation Processes - 2017

    Overview: In this webinar you will learn the different global agencies expectations of analytical equipment qualification along with the development of a sound process validation program in order to develop and implement bulletproof solutions that are accepted, effective, and efficient. Through case study analysis we will examine best practices to provide thoughts and ideas to develop or improve the performance of your current system.
  • 28 Request Info

    Anatomy & Physiology - Online Course

    Accredited self-paced online Anatomy & Physiology course. This course combines an interactive study experience with the convenience of the Internet. Students can enroll at any time and complete the course at their pace. Start learning A & P today! College credit available for an additional fee.
  • 29 Request Info

    Applied Statistics for Scientists and Engineers

    Throughout 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries, the application of statistical methods are specified for: setting validation criteria and specifications, performing measurement systems analysis (MSA), conducting stability analysis, using design of experiment (DOE) for process development and validation, developing process control charts, and determining process capability indices.
  • 30 Request Info

    Applied Statistics, with Emphasis on Risk Management in R&D, QA/QC, and Manufacturing 2017

    The 2-day seminar explains how to apply statistics to manage risks and verify/validate processes in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry. The flow of topics over the 2 days is as follows: ISO standards and FDA/MDD regulations regarding the use of statistics. Basic vocabulary and concepts, including distributions such as binomial, hypergeometric, and Normal, and transformations into Normality. Statistical Process Control Statistical methods for Design Verification Statistical methods for Product/Process Qualification Metrology: the statistical analysis of measurement uncertainty, and how it is used to establish QC specifications How to craft "statistically valid conclusion statements" (e.g., for reports) Summary recommendations Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901366SEMINAR?trainingregistry-December-2017-SEO
  • 31 Request Info

    Applied Statistics, with Emphasis on Verification, Validation, and Risk Management, in R&D, Manufacturing, and QA/QC

    The 2-day seminar explains how to apply statistics to manage risks and verify/validate processes in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry. The flow of topics over the 2 days is as follows: ISO standards and FDA/MDD regulations regarding the use of statistics. Basic vocabulary and concepts, including distributions such as binomial, hypergeometric, and Normal, and transformations into Normality. Statistical Process Control Statistical methods for Design Verification Statistical methods for Product/Process Qualification Metrology: QC Sampling Plans the statistical analysis of measurement uncertainty, and how it is used to establish QC specifications How to craft "statistically valid conclusion statements" (e.g., for reports) Summary recommendations More: https://www.globalcompliancepanel.com/seminar/applied-statistics-with-emphasis-verification-901933SEMINAR/?SEO
  • 32 Request Info

    Applying ICH Q3A and Q3B for Control of Impurities

    Overview: This course is designed to provide participants with an understanding of the regulatory expectations for controlling impurities and degradants (including DNA reactive/potential genotoxic impurities) in drug substances and drug products. There will be ample opportunity to discuss questions and challenges from the participants. Why should you Attend: Upon completion of this course the learner should be able to: Understand regulatory expectations regarding impurities, degradants and potential genotoxic impurities in pharmaceuticals Understand what specifications will conform to regulatory expectations Develop an process for reporting impurities and addressing OOS situations
  • 33 Request Info

    Applying ISO14971 and IEC62304 - A guide to practical Risk Management 2018

    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. keep enhancing: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901453SEMINAR?trainingregistry-January-2018-SEO
  • 34 Request Info

    Aseptic Processing Overview and Validation :2-Day In-Person Seminar

    This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls and acceptable personnel behaviors.
  • 35 Request Info

    Audit Executive - Leading the Internal [Audit Function]

    Overview: This training program will enumerate the IIA Standards and the auditor's responsibility to abide by the standards. The program will also look at management's expectations of internal audit and detail skills required for internal audit management. It will provide real-world examples and challenges facing today's internal audit. "Becoming a Chief Audit Executive -Leading the Internal Audit Function" -This course is approved by NASBA (National Association of State Boards of Accountancy). Attendees of Live Webinar are eligible for 1.8 CPE credit up on full completion of the course.
  • 36 Request Info

    Audit Trail Generation and Review

    Overview This webinar will demystify audit trails and describe the benefits of audit trail for your company. Attendees will the tools required to generate compliant audit trails on a domestic and international basis and will answer the questions on how to handle systems without automated audit trails, in a compliant manner.
  • 37 Request Info

    Audit Trail Generation and Review 2019

    Overview: These electronic records must be maintained according to regulatory requirements contained within FDA's 21 CFR Part 11 for US jurisdictions and Eudralex Volume 4 Annex 11 for EU jurisdictions. Why should you Attend: Attendees will learn how to review audit trails, using a risk based approach to cull through the thousands of audit trail records that can be generated on a daily basis.
  • 38 Request Info

    Auditing Laboratories Conducting Assays Supporting Biologics

    Overview: Sponsors or consultants auditing labs on behalf of a pharmaceutical or biopharmaceutical company need strong tools for preparing and conducting audits.Careful consideration of the work that will be performed at the laboratory provides a working framework for the content of the audit.
  • 39 Request Info

    Auditing Physician Contracts Under the New Stark Rules

    In this webinar Mr. Wolfe Discuss best Practices for Auditing Physician Compensation Arrangements and Potential Pitfalls, also Discuss how to Resolve Issues that may arise During the Audit Process.
  • 40 Request Info

    Avoiding Critical R&D Formulation/Drug Delivery Errors

    We hopefully learn from our mistakes. But, it is far better to learn from other people’s errors and avoid them in the first place. In nearly 40 years of R&D in the pharmaceutical industry, I’ve made--and seen-- some doozies— technical errors, miscommunications, strategic planning oversights, and quite a few “political” blunders. Many, if not all, were preventable. All were costly! For example, over a multi-year period, our manufacturing plant had an occasional release-assay failure, for commercial heparin in intravenous bags. The plant did not consider it a serious problem because re-testing, with a larger sample size, nearly always was successful; the problem was attributed to assay-error and most of those lots were released. Suddenly, every batch failed. It was only then, that the Manufacturing Group got our R&D involved.