Medical Devices

Compliance Trainings would provide training on various concepts like Class I, II and III devices, 510(k), Premarket Approval (PMA), IVD’s (In Vitro Diagnostics) and Current Good Manufacturing Practices (cGMP). https://compliancetrainings.com/SiteEngine/MedicalDevices.aspx
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Webinar On FDA’s New Guidance On Medical Device Development Tools  This webinar will discuss a voluntary process for qualification of Medical Device Development Tools (MDDT) for use in device development. An MDDT is a scientifically validated tool (test) to determine clinical outcome.   For more information visit  https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1401

Webinar On FDA’s New Guidance On Medical Device Development Tools This webinar will discuss a voluntary process for qualification of Medical Device Development Tools (MDDT) for use in device development. An MDDT is a scientifically validated tool (test) to determine clinical outcome. For more information visit https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1401

Webinar On The 510(k) Program: Substantial Equivalence In Premarket Notifications  This webinar is a must for those personnel that require an understanding of the FDA's 510(k) substantial equivalence determinations.  For more information visit  https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1229

Webinar On The 510(k) Program: Substantial Equivalence In Premarket Notifications This webinar is a must for those personnel that require an understanding of the FDA's 510(k) substantial equivalence determinations. For more information visit https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1229

Webinar on Medical Device User Fee Act (MDUFA) III Scheduled On Tuesday, June 10, 2014 at 13:00 Hrs  This webinar will present the results of the MDUFA III and will describe how your company will need to do business with the FDA in the next five years.  For more information visit  https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1056

Webinar On How to select Software for a Regulated Environment Scheduled On : Monday, March 2014 at Hrs Duration : 120 Minutes

Webinar On HIPAA Privacy and Security 2014 Update, Including the Latest Trends in Omnibus Breach on Today at 13:00 Hrs.  . This presentation is delivered in a manner that is understandable by all parties that work to maintain HIPAA and other forms of privacy and security compliance.  For more information visit  https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=HC1280

Webinar On How to select Software for a Regulated Environment Scheduled On : Monday, March 2014 at Hrs Duration : 120 Minutes

Webinar On Best Practices for 510(k) Drafting and Submission: Dos and Don'ts Scheduled On Friday, October 17, 2014 at 13:00 Hrs Speaker: Dr. David Lim President and Principal of Regulatory Doctor by Compliance Trainings.  This session is a must for regulatory professionals working in medical device industry including those who are interested in the topic.  For more information visit https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1354

Webinar On - Good Documentation Practices for Clinical Trials Scheduled On : Tuesday, February 2014 at Hrs

Webinar on Quality System Regulations (QSRs) for Medical Devices and IVDs Scheduled On Tuesday, July 1, 2014 at 13:00 Hrs. This webinar will address the said current good manufacturing practice (cGMP) requirements to help you stay in conformity with 21 CFR Part 820 (QSR). https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1351

Webinar On - Good Documentation Practices for Clinical Trials Scheduled On : Tuesday, February 2014 at Hrs

Webinar On 510(k) Updates: Trends, New Strategy and FDA Clearance by Dr. David Lim Scheduled On Wednesday, June 4, 2014 at 13:00 Hrs.  This webinar will provide an opportunity to get familiar with an FDA’s process to communicate with the industry early in the process for sustainable 510(k) preparation and submission including recent 510(k) trends and updates.  For more information about this webinar visit https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1119

Webinar On - Good Documentation Practices for Clinical Trials Scheduled On : Tuesday, February 2014 at Hrs

Webinar On Medical Device Reporting - How to establish and maintain adequate procedures by Dr. David Lim scheduled on Wednesday, May 14, 2014 at 13:00 Hrs.  This webinar is intended to help you avoid FDA 483s and warning letters for failure to establish and maintain adequate procedures for medical device reporting.  For more information visit  https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1118

Webinar On - Good Documentation Practices for Clinical Trials Scheduled On : Tuesday, February 2014 at Hrs

Webinar On Master Validation Planning To Meet U.S. FDA cGMP, ISO 13485, and ICH Q9 / ISO 14971 Requirements  This 90 minute in-depth webinar discusses the FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in big name device and pharma companies, many going back to insufficient, poor or non-existent V&V planning.  For more information visit  https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1266

Webinar On - Key Regulatory Documents: Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) and Design Dossier Scheduled On : Wednesday, February 2014 at Hrs

Webinar On Failure Investigation, Root Cause Analysis - Tools and Techniques Scheduled On Wednesday, June 25, 2014 at 13:00 Hrs.  This webinar will provide valuable assistance to all regulated companies that need to review and modify their company's FI / RCA, and V&V / CAPA system.  For more information visit https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1262

Webinar On - Key Regulatory Documents: Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) and Design Dossier Scheduled On : Wednesday, February 2014 at Hrs

Webinar On #Medical #Device #Recall - #FDA #Authority, Policy and Best Practices to Avoid and Manage Scheduled On Tuesday, June 17, 2014 at 13:00 Hrs.  In This webinar You will learn how to establish a roadmap for conducting recalls. The recall management knowledge you gain will sharpen how you determine the health and legal risks associated with your #recall and what you can do to avoid future recalls.   https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1125

Webinar On Managing the FDA form Inspection Observations will be held on Tuesday, March 2014 at Hrs Duration : 60 Minutes FDA medical device Food and Drugs Administration Pharma Regulatory compliance

Webinar on FDA’s Training Requirements for Medical Device Manufacturers by Mr. Uldriks Scheduled On Monday, May 19, 2014 at 13:00 Hrs.  This webinar will provides training to various fda requirements for medical device manufactures.  For more information visit  https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1124

Webinar On Managing the FDA form Inspection Observations will be held on Tuesday, March 2014 at Hrs Duration : 60 Minutes FDA medical device Food and Drugs Administration Pharma Regulatory compliance

Webinar On Creating Design History Files (DHF), the Device Master Records (DMR) and the Device History Records (DHR), Utilizing the Principles of Lean Documents and Lean Configuration https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1048

Webinar On Creating Design History Files (DHF), the Device Master Records (DMR) and the Device History Records (DHR), Utilizing the Principles of Lean Documents and Lean Configuration https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1048

What is a Quality Management System (QMS)?  It is a management system pure and simple.  It is not quality’s management system; it is a management system that, if done right, produces quality products. A Quality Management Systems is built for ISO registration, to satisfy customer requirements, or to produce better products. In this webinar Ms.  Marie Dorat provides an overview of the Quality Management System requirements. We will discuss ISO Quality Management standards and the FDA Quality…

What is a Quality Management System (QMS)? It is a management system pure and simple. It is not quality’s management system; it is a management system that, if done right, produces quality products. A Quality Management Systems is built for ISO registration, to satisfy customer requirements, or to produce better products. In this webinar Ms. Marie Dorat provides an overview of the Quality Management System requirements. We will discuss ISO Quality Management standards and the FDA Quality…

This webinar will provide valuable assistance to all U. S. FDA-regulated companies. It will assist in their reviewing and modifying their regulatory compliance stance in view of the areas the FDA indicates are of growing / future interest / emphasis. Its principles apply to personnel / companies in the Medical Devices, Pharmaceutical, Diagnostic, and Biologics fields.

This webinar will provide valuable assistance to all U. S. FDA-regulated companies. It will assist in their reviewing and modifying their regulatory compliance stance in view of the areas the FDA indicates are of growing / future interest / emphasis. Its principles apply to personnel / companies in the Medical Devices, Pharmaceutical, Diagnostic, and Biologics fields.

In this webinar Dr. Christopher Joseph Devine will help your organizations better understand the FDA’s expectations for purchasing and supplier controls, while providing insight into tools needed for establishing an effective approach for purchasing and supplier management. Don’t miss this valuable session from Dr. Christopher Joseph Devine Last date will be sign up is Sunday, June 28, 2015

In this webinar Dr. Christopher Joseph Devine will help your organizations better understand the FDA’s expectations for purchasing and supplier controls, while providing insight into tools needed for establishing an effective approach for purchasing and supplier management. Don’t miss this valuable session from Dr. Christopher Joseph Devine Last date will be sign up is Sunday, June 28, 2015

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