Seminar - Online
The webinar clarifies the regulatory concern that FDA has and whether subjecting Laboratory Developed Tests (LDTs) to FDA's device Quality System Regulation can make a measurable difference in the safety and effectiveness (reliability) of special IVDs.
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June,
Webinar,
Quality Control,
Health Care,
2015,
Seminar,
laboratory,
Biologics
Seminar - Online
This course will provide guidance on best practices for developing and implementing a good plan detailing responsibilities, and deliverables to make validation efficient, and consistent.
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June,
Medical Device Technology,
Webinar,
2015,
Seminar
Seminar - Online
If your organization is struggling with understanding the salient requirements associated with purchasing and supplier controls, this webinar is for you.
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June,
Medical Device Technology,
Webinar,
2015,
Seminar,
1 day only
Seminar - Online
Being in compliance with HIPAA involves not only ensuring you provide the appropriate patient rights and controls on your uses and disclosures of protected health information, but you also have the proper policies and procedures in place.
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Tags:
Healthcare,
Webinar,
May,
2015,
Seminar
Seminar - Online
Vital elements of a robust, "bullet-proof", "closed-loop" Corrective and Preventive Action (CAPA) program include: "Gatekeeper" capture, investigation, verify/validate, monitor, change control methodology, coupled with accurate root cause analysis.
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Tags:
June,
Medical Device Technology,
Webinar,
2015,
Seminar
Seminar - Online
Developing a Quality Management System (QMS) as a prerequisite for getting accredited is relatively easy. Maintaining the QMS to retain your accreditation status is the real challenge and a measure of the robustness your System.
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Tags:
June,
Webinar,
Quality Control,
2015,
Seminar,
laboratory,
Biologics
Seminar - Online
This presentation is intended to help you get familiar with best practices for quality risk management (QRM) applicable to pharmaceutical industry (drugs, biosimilars, and biologics) as well as medical device industry.
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Tags:
Medical Device Technology,
Webinar,
May,
Quality Control,
pharmaceutical,
2015,
Seminar,
Biologics
Seminar - Online
This lesson will be going into great detail regarding you practice or business information technology and how it relates to the HIPAA Security Rule.
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Tags:
June,
Healthcare,
Webinar,
2015,
Seminar
Seminar - Online
FDA recently issued final 510(k) guidance, providing FDA’s policy on the 510(k) program.
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Tags:
Medical Research,
Medical Device Technology,
Webinar,
May,
2015,
Seminar
Seminar - Online
HACCP Hazard Analysis and Critical Control Points is a management system in which product safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product.
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Tags:
Webinar,
May,
Quality Control,
2015,
Seminar,
Biologics
