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Vaccines and immunotherapeutics on the rise

Vaccines and immunotherapeutics on the rise

  • 2 Months ago
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HIPAA Compliance and Patient Care

Incidental disclosures form the crux of HIPAA compliance and patient care. HIPAA has elaborate rules on how to maintain these and in what situations.Health Insurance Portability and Accountability Act (HIPAA), a landmark set of federal regulations, is aimed at protecting patient privacy regulations. Yet, it is understood that some information has to necessarily be shared. HIPAA compliance and patient care is centered on the inevitable disclosures that ..

  • 2 Months ago
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CAPA Root Cause Analysis in 2016 by Compliance4all

Overview:  The course takes one through the rigors of RCA as it applies to CAPA. There are ways of making the journey easier and structuring it so that the right answers are arrived at. This presentation presents highlights of a proper RCA, RCA tools and discusses dos and don'ts with regard to RCA.Why should you Attend: To learn the basics, understand what it is that the regulators are looking for. Establish a robust system for Root Cause Analysis. The co..

  • 2 Months ago
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Validation Planning and Documentation in 2016 by Compliance4all

Overview:  The verification and validation of medical software is coming under increased scrutiny by the U.S. FDA. This webinar will address the use of the FDA, GAMP, 21 CFR Part 11, "Electronic Records" / "Electronic Signatures", and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Product Risk Management models, to plan, structure, run, and document acceptable software validations.Why should you attend: Software ..

  • 2 Months ago
  • 61 Views
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Laboratory Investigation of Out-of-Specification Results in 2016 by Compliance4all

Overview:  The objective of this webinar is to develop an understanding of how a compliant laboratory handles the investigation of out-of-specification (OOS) test results and how the laboratory interfaces with other units through the laboratory investigation process. The discussion will be based on the FDA guidance on handling OOS laboratory results.This live webinar training will provide a clear process for compliant laboratory OOS investigations. Why sh..

  • 2 Months ago
  • 86 Views
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Developing a Cyber Incident Response Program in 2016 by Compliance4all

Overview:  The best way forward is an efficient Incident Response Program that allows an organization to respond with speed and agility, while empowering businesses to maintain continuous operations. Such a solution also reduces revenue loss, reduces fines and lawsuits and protects brand reputation.Why should you Attend: Do you have great procedures in place to deal with a Breach, Malware and more? Are you willing to risk your Business Reputation on those..

  • 2 Months ago
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Continuity Planning and Recovery in 2016 by Compliance4all

Overview:  Lean principles for Continuity Planning, when practiced every day in a consistent manner, align business systems and processes with the needs and goals of the organization. It is a common sense and practical approach to problem solving focused on eliminating waste. Lean thinking is a strategy that is used at any level of the organization and applied to any process or work area. It delivers rapid, measurable results.Areas Covered in the Session:..

  • 2 Months ago
  • 65 Views
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Calibration in the Laboratory in 2016 by Compliance4all

Overview:  This web seminar builds on the terminology found in 21CFR160(b)(4) and introduces terminology and concepts not found in the regulation , but necessary for an effective calibration program, such as instrument classifications.Why should you Attend:The regulatory and technical requirements for calibration.What should be included in a calibration programThe importance of a data-based calibration interval and limits of accuracy and precisionThe impa..

  • 2 Months ago
  • 64 Views
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HIPAA Business Associate Agreements-an understanding

Business Associate agreements are designed to perform a number of important functions. They are meant to safeguard and secure patient healthcare information.In simple terms, a HIPAA Business Associate agreement, abbreviated to BAA, is a contract that a HIPAA Covered Entity enters into with a HIPAA Business Associate (BA) agreeing to ensure protection of Personal Health Information (PHI) in compliance with HIPAA guidelines.This is fundamentally required be..

  • 2 Months ago
  • 123 Views
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FDA's Medical Device Clinical Trials Program in 2016 by Compliance4all

Overview:  The yearly payment volumes - B2B only - of processors such as CHIPS, Fedwire, SWIFT, and ACH are growing steadily, while checks are declining at a small single-digit rate.Businesses of all sizes are trying to send payments in the most cost-effective way and not necessarily through the bank- established channels. Corporate financial professionals want a conversion from paper to electronic payments, but only if they can get the payment informatio..

  • 2 Months ago
  • 80 Views
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