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Courses

  • 21 Request Info

    6-Hour Virtual Seminar on Auditing Analytical Laboratories for FDA Compliance

    There are two phases to this topic. The first is auditing itself. Good audits are well structured. They must consider the reasons for the audit, the regulatory requirements, as well as the nature of the laboratory being audited. We will discuss the considerations that must be made when auditing a laboratory. The social interactions that must be expected, the nature of the regulatory requirements and the nature of work that the laboratory performs will be discussed.
  • 22 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.
  • 23 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.
  • 24 Request Info

    6-Hour Virtual Seminar on Data Integrity: Learn to Comply with the FDA Expectations and Avoid Facing Penalties

    The impact of Data Integrity issues on a regulated company can be significant: it can result in recalls of products, warning or untitled letters, import alerts, injunctions, seizures, legal action, etc. These regulatory actions can have significant financial impact to the company. However, and most importantly, Data Integrity issues can lead to potential patient harm!! To ensure Data Integrity, a GxP regulated company needs to abide by principles, current regulations and industry best practices on the expectations for the management GxP regulated records and data. These principles, regulations and best practices, ensure that data is complete, consistent, accurate, secure and available throughout the record life cycle. This approach is intended to encourage innovation and technological advances while avoiding unacceptable risk to product quality, patient safety and public health.
  • 25 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.
  • 26 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.
  • 27 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.
  • 28 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.
  • 29 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.
  • 30 Request Info

    6-Hour Virtual Seminar on Tougher Import Rules for FDA Imports in 2020

    Importing FDA regulated products requires careful planning before you even start. Registration, product compliance, record and data submission must be exactly correct or your product will be detained. Likewise, the U.S. Customs and Border Protection (CBP) must be precise or your entry is not going anywhere. Some mistakes are common, others reflect a lack of understanding of how FDA and Customs and Border Protection (CBP) operate a joint program. The logistics of importing products complicates the process further and you must know the consequences of your decisions. Some problems can cost you time and money, especially when you do not work promptly with the FDA. If you end up with having your entry "refused." There is no appeal. Then you face the possibility of additional steep fines by CBP and be blocked from the U.S. market.
  • 31 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
  • 32 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.
  • 33 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.
  • 34 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.
  • 35 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.
  • 36 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.
  • 37 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. Different statistical methods are required for each of these particular applications. Data and tolerance intervals are common tools used for setting acceptance criteria and specifications. Simple linear regression and analysis-of-covariance (ANCOVA) are used for setting expiries and conducting stability analysis studies. Two-sample hypothesis tests, analysis-of-variance (ANOVA), regression, and ANCOVA are methods used for analyzing designed experiment for process development and validation studies.
  • 38 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
  • 39 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
  • 40 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