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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

  • 1 Months ago
  • 152 Views
  • 81 Comments
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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.

  • 1 Months ago
  • 155 Views
  • 84 Comments
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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

  • 1 Months ago
  • 156 Views
  • 75 Comments
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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.

  • 1 Months ago
  • 154 Views
  • 83 Comments
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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

  • 1 Months ago
  • 494 Views
  • 351 Comments
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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

  • 1 Months ago
  • 144 Views
  • 81 Comments
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Why you Should be Worried about HIPAA 2017

Practice Managers Compliance Officers, and any Business Associates Privy to Private Health Information and Under the Auspices of this Law.

  • 1 Months ago
  • 165 Views
  • 82 Comments
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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

  • 1 Months ago
  • 152 Views
  • 77 Comments
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Data Integrity, 21 CFR 11 & Annex 11 Implementation 2017

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

  • 1 Months ago
  • 151 Views
  • 81 Comments
  • 0 Likes

Regulatory Requirements and Principles for Cleaning Validation 2017

This 2 day course will cover practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity planning.

  • 1 Months ago
  • 160 Views
  • 84 Comments
  • 0 Likes