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Author: charles ben

Company: globalcompliancepanel

Region: USA

Website: www.globalcompliancepanel

Author Comment / Biography:
GlobalCompliancePanel is an online training gateway delivering high quality regulatory & compliance trainings in a simple, cost effective and in a user friendly format.

GlobalCompliancePanel offers a broad range of channels for broadcasting and exchange of information through web based training, web alerts & discussion forums.

GlobalCompliancePanel imparts knowledge of best practices in industry to guarantee effective implementation of compliance programs for meeting regulatory demands. The key focus of GlobalCompliancePanel is to provide extensive and quality training for risk management, regulatory compliances, corporate governance and quality management. Apart from providing excellent training to compliance professionals by compliance & consulting experts, GlobalCompliancePanel would also focus on providing:

Information to ensure compliance and enhance quality with regulations for individuals as well as the organizations Latest updates on industry trends, industry best practices and any modifications in the regulatory affairs One stop destination for all your queries and to share and discuss issues, ideas and best practices and A resource on the data sheets, whitepapers, articles, books on industry standards, training kits, software tools, insights, press releases, etc on governance, regulatory, compliances and quality management across different industries.

GlobalCompliancePanel plays a role of bringing together the regulators or experts on regulation with the community who needs to learn or be aware of those regulations. GlobalCompliancePanel is started with the goal to create an excellent interactive platform for the experts and the user community thereby making costs of training more affordable with increased convenience.

GlobalCompliancePanel strives to understand the changing customer needs and enrich their quality of life by simply providing world-class training to increase their productivity and professional growth. Global Compliance Panel enables the companies in triggering business processes through regulatory notifications and industry alerts.

Displaying 101 to 110 of 132 articles < Back | Next >
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 Articles by charles ben 
101. DHF, DMR, DHR and TF - Regulatory Documents Explained - Webinar By GlobalCompliancePanel
March 27, 2013

Overview: The FDA QSR and the Medical Device Directive specify certain records that should be included in your organization's quality system - Design History File (DHF), Device Master Record (DMR), Device History Record (DHR), and Technical File (TF).

Are yours adequate? Do you know what in...

102. 510(k): Format and Contents - Webinar By GlobalCompliancePanel
March 27, 2013

Overview: This webinar is intended to demonstrate how to prepare a 510(k) in an adequate manner with increased quality to expedite the streamlined review process. The premarket notification [510(k)] is the most common pathway to market for medical devices including in vitro diagnostic medical device...

103. Managing Your Medical Device Reporting (MDR)Program for Compliance Success - Webinar By GlobalCompl
March 27, 2013

Overview: Medical Device Reporting (MDR) is the mechanism for the Food and Drug Administration to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly. If you are a consumer or health professional you shoul...

104. Key Factors to develop an effective CAPA system - Webinar By GlobalCompliancePanel
March 27, 2013

Overview: Having an effective CAPA documentation and tracking system are crucial to pharmaceutical operations. This system will allow personnel to identifying the root cause, corrective action taken, and verification stages. This session will discuss important components to create an effective CAPA ...

105. New EU Pharmacovigilance Directive and Regulations - Webinar By GlobalCompliancePanel
March 27, 2013

Overview: New Legislation & Guidance for Pharmacovigilance will apply in the European Union (EU) beginning July 2012. To assist in its implementation with sponsors, applicants and license holders, a series of Guidance Documents is being written, which will replace the current set of Volume 9A of the...

106. Effective, Risk Based Implementation of the Quality Systems - Webinar By GlobalCompliancePanel
March 27, 2013

Overview: This webinar will define the concepts behind the application of the Quality systems to drug operations and the specific elements as discussed on the ICH Q-10. The course will include specific discussions on the enablers for the QS implementation and on each QS element from a risk-based app...

107. Batch Production Record and Device History Record Review and Quality Assessment - Webinar By Globa
March 27, 2013

Overview: Written procedures are to be established and followed for a time efficient and clear evidence of the quality related elements during the review and approval for release, including packaging and labeling, to determine compliance of the intermediates (FDA definition) and/or finished product ...

108. FDA Inspections - How Investigators Typically Process the Results - Webinar By GlobalCompliancePane
March 26, 2013

Overview: The presentation will cover important documents such as the Establishment Inspection Report, and the FDA Notice of Observations. The presentation will also cover the different steps the investigator takes after he/she finishes the inspection and writes the Establishment Inspection Report i...

109. Ten-Step Process for COTS Computer System Validation - Reduce Time and Costs - Webinar By GlobalCom
March 26, 2013

Overview: This webinar details all of the templates used to create validation documentation, usually saving two-thirds of the time and costs. The 10-step risk-based approach to COTS software validation minimized documentation and ensures efficient implementation of new and upgraded computer systems....

110. FDA QSR Acceptance Activities - Webinar By GlobalCompliancePanel
March 26, 2013

Overview: This webinar explains the regulations and provides guidance on their implementation. We cite the regulations and discuss the FDA's intent as provided in the preamble to the regulations. We explain the advice offer FDA's QSR Manual. This guidance helps manufacturers implement the regulation...

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