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  • 1 Request Info

    Understanding International ACH - 2017

    Overview: Instructor will cover customer benefits and value proposition regarding International ACH and why it may be preferred over wire transfers. Why should you Attend: This webinar will explain what International ACH is, how it works and more about an organization that is creating global standards to make it even easier. It will discuss the rationale for choosing International ACH and how it differs from US domestic ACH.
  • 2 Request Info

    Training Certificate

    The ATD Training Certificate content is practical and grounded in the real world, not just academic theory. This program focuses on what happens before, during, and after you deliver training, and what to do if training is not the right solution. With input from ATD’s Competency Study, we identified the competencies required by the most successful practitioners. The Training Certificate Program is aligned with the Training Delivery Area of Expertise in the ATD Competency Model. Learner feedback indicates high value in the following areas: student engagement, expert facilitation, and applicable tools and techniques.
  • 3 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. Descriptive statistics (distribution
  • 4 Request Info

    HIPAA for the Compliance Officer 2017

    I will be going into great detail regarding you practice or business and how it relates to the HIPAA Security/Privacy Rule, Areas covered will be history of HIPAA, privacy vs security, business associates, changes for 2016, audit process, paper based PHI, HIPAA and suing, texting, email, encryption, medical messaging, voice data and much, much, more I will uncover myths versus reality as it relates to this very enigmatic law based on over 600 risk assessments performed as well as years of experience in dealing directly with the Office of Civil Rights HIPAA auditors. I will also speak to real life audits conducted by the Federal government (I've been on both sides of these audits) what your highest risks are for being fined (some of the risk factors may surprise you).
  • 5 Request Info

    Applying U.S. FDA Laws and Regulations to Each Phase of Total Product Life Cycle (TPLC)

    This workshop style training course is supported by comprehensive knowledge of U.S. FDA laws and regulations and 30 year of extensive experience working within in the U.S. FDA regulated industries. In these 2 days, the following essential topics will be covered: Total Product Life Cycle and Your Medical Device An Overview of U.S. FDA Medical Device Regulation Regulations for Design and Product Development Premarket Notification - 510(k) and Premarket Approval (PMA) Regulations for Production & Process Control Readiness for FDA Facility Inspection
  • 6 Request Info

    Marketing, Advertising and Promotion of Pharmaceuticals and Medical Devices 2017

    The changing game for drug and device marketing, however, is governed by antiquated and inadequate rules created for traditional print and broadcast advertising by the Food and Drug Administration ("FDA"). How the FDA will deal with such advanced communication technology that can go "viral" and just as quickly disappear is the question that the industry is eager to have answered. The FDA regulates the promotion of prescription drugs, biologics, medical devices and biotechnology products to ensure that the information is not false or misleading. The FDA has for decades regulated traditional advertising for decades, published various guidance documents for industry and issued many violation letters. If the FDA determines that drug or medical device promotional material is false or misleading or lacking in fair balance as between benefits and risks, companies could be forced to implement costly corrective actions, such as remedial advertising, suffer damage to their reputations
  • 7 Request Info

    Master HIPAA Compliance in Six Steps 2017

    The secret is - HIPAA Rules are easy and routine to follow - when they are explained step-by-step in plain language. In this seminar Paul Hales will capture your attention with visual presentations, discussion and learning exercises and show how to find the right rule with the step-by-step procedures you need when you need them. Seminar Takeaways: Thorough Understanding of HIPAA Rules What they are How they work together Why and How they were made How they are changing and what to expect next HIPAA Risk Analysis - Risk Management for Your Organization A Practical Guided Exercise done in class on your computer to take home Privacy and Security Rules - Permitted and Required Uses and Disclosures
  • 8 Request Info

    Roadmap to Advanced Human Resources and Employment Law 2017

    Are You Prepared for the New Presidential Administration? Is your company at risk for non-compliance? Is your company a lawsuit waiting to happen? 2017 comes in with a lot of uncertainties. With a new administration in the white house, employers can expect drastic change, which may affect and impact your organization. Additionally, employment lawsuits are on the rise. Last year, Equal Employment Opportunity Commission (EEOC) enforcement collected $372.1 million in monetary damages, the highest recovery in agency history. Also, for the last three years, the EEOC reported a record high number of claims filed by employees. When employers are not properly prepared for workplace issues, companies could face discrimination suits, litigation, settlements, lawyer fees, unplanned expenses, employee turnover, morale issues, and possible negative community image. This Advanced Human Resources and Employment Law Seminar will assist companies in being prepared for the new administration,
  • 9 Request Info

    Incorporating Risk Management into Your HR Policy 2017

    HR audits are designed to help your organization focus its attention on its human resource management practices, policies, procedures, processes, and outcomes by providing you with a structured and systematic series of questions about key compliance, risk management, internal auditing, and human resource management issues. As a process, HR audits are designed to help your organization identify potential and actual problem areas, help assess the effectiveness of current HR management activities, help assess weaknesses in HR internal control processes, and help assess human capital strategic and compliance related risks. HR audits should additionally provide suggestions for corrective action.
  • 10 Request Info

    Background Checks, Criminal Records and Safe Hiring 2017 Effective and Compliant Program 2017

    Employee problems are caused by problem employees, and this session will help HR professionals legally avoid bad hires in the first place. Just one bad hire can result in a legal and financial nightmare. Without taking appropriate steps, there is a near statistical certainty that an employer will hire someone with an unsuitable criminal record, or a falsified background, that can result in workplace violence, lawsuits for negligent hiring and time wasted recruiting and hiring the wrong person. On the other side of the screening fence, are the rising tides of lawsuits against employers alleging screening methods violate the law or are at odds with changes in civil rights legislation and the new EEOC Guidance on the use of criminal records. The screening landscape is more complex than ever.
  • 11 Request Info

    Applied Statistics, with Emphasis on Risk Management 2017

    The 2-day seminar explains how to apply statistics to manage risk 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. 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, from a risk management perspective
  • 12 Request Info

    Laboratory, Medical and Device Performance and Validation following Regulatory 2017

    This course is designed to introduce to individuals the understanding and interpretation of the statistical concepts one uses when investigating quantitative ICH Guidelines such as analytical methods validation, procedures and acceptance criteria in calibration limits, and process and quality control. One also considers ICH Q8 and Q9. These techniques covers both clinical and laboratory applications. This applies to many areas such as stability testing, outlier analysis and risk management. It is not a course in statistics but introduces the participant to an applied approach to the statistical techniques one uses, how they are reasonably interpreted. One will address the various challenges facing pharmaceutical and biotechnology companies when it comes to quantifying results in a meaningful interpretable manner through tabulations and graphical presentations.
  • 13 Request Info

    Modern HIPAA Compliance - Managing Privacy, Security, and Breach Notification in a World of New Technologies, New Threats, and New Rules 2017

    Day one sets the stage with an overview of the HIPAA regulations including HIPAA Breach Notification and the process that must be used to determine whether or not a breach is reportable, and then continues with presentation of the specifics of the Privacy Rule, recent changes to the rules, and the basics of the Security Rule. Rules about Patient Rights and the limitations on uses and disclosures by covered entities will be explained, including recent guidance on access of PHI by individuals and sharing information with family and friends of a patient, and the latest rule changes for substance abuse information under 42 CFR Part 2. Discussion will include the impacts of the 21st Century Cures Act as well as the repeal of the Affordable Care Act, and potential impacts of privacy concerns combined with immigration crackdowns on the accuracy and completeness of records on individuals who may fear deportation.
  • 14 Request Info

    HIPAA Compliance Training 2017

    This two day seminar takes the participants through HIPAA compliance from start to compliance. The first presentation explains the history of HIPAA, why it came to 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. At the end of these presentations there will be a workshop to demonstrate how to use these tools. The second session describes what a Risk Assessment is and how to perform the risk assessment. The materials take the participant through the factors of HIPAA compliance and how to perform a HIPAA Risk Assessment. This encompasses taking the participants through how to do a HIPAA Privacy Risk Assessment, how to do a HIPAA Security
  • 15 Request Info

    Audit Like the FDA Audit Like the FDA 2017

    This 2 day seminar will explore how to create and implement an efficient and effective internal audit program. Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to identify areas of non-compliance. A well-designed audit program can be an effective tool in understanding, communicating, and reducing quality and compliance risk. However, estimates indicate that up to 75% of companies conduct audits only because they are required to by regulation. Businesses often see internal audit as a non-value added activity leading to meaningless findings, bureaucracy, and cumbersome processes. And despite having an internal audit program, management is often surprised when they receive a 483, Warning Letter, or even a Consent Decree. A well planned audit program can reduce these risks.
  • 16 Request Info

    Measure the Cause Not the Effect of Process Variation

    Process Reliability Modeling (PRM) examines organizations transactional, reliability engineering training or manufacturing processes to determine the likelihood of passing work through each process with errors resulting in costly rework and customer disaffection. Reliability training courses of every process is accomplished by interviewing all employees by process throughout the organization. Qualitative information gained from interviews is analyzed using Cause and Effect Diagrams.
  • 17 Request Info

    FDA and EMA Global labeling challenges faced in day-to-day operations

    Pharmaceutical companies must manage the process of designing and creating product labels that meet regulatory requirements. This includes product-labeling documents such as Packet Inserts (PIs), Summaries of Product Characteristics (SmPCs) and Core Data Sheets (CDSs). The large number of product strengths, dosage forms and product presentations results in a large number of labeling records that must be maintained and kept synchronized. The FDA and EMA are implementing a set of rules for the electronic submission of labeling content. The FDA labelling regulation requires companies to submit XML labeling content in Structured Product Labeling (SPL) format. The EMA labelling regulation requires companies to submit product information documents in QRD-compliant format.
  • 18 Request Info

    The New Clinical Trials Regulation and Regulatory Affairs Aspects 2017

    The main document from a regulatory perspective in the development of a medicinal product is the regulatory plan. In this Seminar it is explained how to write the regulatory plan, and which aspects to consider. The regulatory plan describes the regulatory strategy, as well as pricing and reimbursement issues in your development. Orphan medicinal Products will be discussed, and the advantages of having a status as an orphan medicinal product will be explained. Scientific advice is a vital element in the development of a medicinal product, and knowledge of the how to choose between national and EU scientific advice, as well as the preparation and procedure is vital for a successful outcome Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900936SEMINAR?channel=mailer&camp=Seminar&AdGroup=trainingregistry_April_2017_SEO
  • 19 Request Info

    FDA Data Integrity for Computerized Systems 2017 | 21 CFR 11

    The Problem: We have all heard of Data Integrity but do you really understand what it is? Do you understand how 21 CFR 11 and Annex 11 fit into this picture? Specifically, can you answer questions on the following: Evolution of 21 CFR Part 11 and Annex 11 and Why they are Back in the News Overview and Key Requirements of Part 11 & Annex 11 How to use a Risk Based Assessment to reduce work while still achieving Data Integrity and Compliance? How FDA & other Regulatory Authorities Inspect Computerized Systems for Data Integrity? I often refer to 21 CFR 11 and Annex 11 as Good Software Engineering with the Documentation on Steroids! However, unless one knows how to implement Data Integrity Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900944SEMINAR?channel=mailer&camp=Seminar&AdGroup=trainingregistry_April_2017_SEO
  • 20 Request Info

    Medical Devices Industry and Risk Management 2017

    Gaps, incorrect or incomplete implementation of software 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 device software in a regulatory compliant environment. Software risk management has to be embedded into the bigger scope of overall risk management. Therefore this course will additionally address the system level risk management and the resulting interfaces to software. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900888SEMINAR?channel=mailer&camp=Seminar&AdGroup=austinmonthly_April_2017_SEO