HIPAA - How Business Associates Can Comply Calmly, Confidently and Completely 2017

HIPAA Rules are easy to follow, step-by-step, once you know the steps. In this seminar Paul Hales will capture your attention with visual presentations, exercises and discussion that explain HIPAA compliance in plain language

  • 10 Days ago
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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.

  • 10 Days ago
  • 18 Views
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FDA's Latest Regulations for Computer Systems Used in the Tobacco and Related Industries, Effective 08/08/2016

FDA Tobacco Control Act Extension of FDA oversight to Vapor, e-Cigarette, Cigar and other industries Details of the August 8, 2016 FDA "Deeming" Regulation Pre-Marketing Tobacco Application (PMTA) Submission FDA Oversight and Compliance Strategy Computer System Validation (CSV) and the System Development Life Cycle Methodology (SDLC) Cost vs. Compliance Policies and Procedures Leveraging Vendors Industry Best Practices FDA Trends

  • 10 Days ago
  • 21 Views
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Drug dissolution testing and establishing plasma drug levels in humans 2017

Drug dissolution testing is an essential and critical step for appropriate and efficient product development such as tablet and capsule. A number of approaches are used to conduct dissolution testing using different apparatuses and methods. Making a choice for an appropriate apparatus and method has always been confusing and challenging.

  • 10 Days ago
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Applied Statistics for Scientists and Engineers 2017

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

  • 10 Days ago
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FDA's Software Monsters: Cybersecurity, Interoperability, Mobile Apps and Home Use 2017

Software's level of complexity and use is expanding at exponential levels. Likewise, the potential risks to health follow suit. Ransomeware attacks hold your software hostage until you pay hundreds or thousands of dollars

  • 10 Days ago
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Vaccines and immunotherapeutics on the rise

Vaccines and immunotherapeutics on the rise

  • 1 Years ago
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Electronic Health Records Software License Agreements 2016

Overview: For physician practices just setting foot into the EHR arena, and for those practices transitioning to a new EHR software package, the fundamental document controlling their experience will be the EHR license agreement. The license agreement will -- or should -- determine issues such as how whether and how often the vendor may make online portions of the software unavailable for maintenance or other issues; how many people may use the software a..

  • 1 Years ago
  • 556 Views
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Responsibilities of a HIPAA Privacy & Security Officer 2016

Overview: Discussions, presentation, and webinars regarding HIPAA regulations are usually addressed from the perspective of what the regulations entail, the necessity of compliance with the regulations, and the consequences of willful neglect or non-compliance. This presentation addresses HIPAA regulations from a different perspective - from a personal perspective - from the perspective of the person in charge of moving an organization or facility toward f..

  • 1 Years ago
  • 526 Views
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HIPAA Under Texting and E-mail with Patients 2016

Overview: This session will focus on the rights of individuals to communicate in the manner they desire, and how a medical office can decide what is an acceptable process for communications with individuals. The session will explain how to discuss communications options with individuals so that you can best meet their needs and desires, while preserving their rights under the rules.With the new HIPAA random audit program now getting under way, and increas..

  • 1 Years ago
  • 462 Views
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