Past Events (3,027)

FDA 510(k) Requirements, Submission, and Clearance: Best Practices

October 5, 2015 from 6pm to 7pm – Mississauga Description : This presentation will walk you through how to prepare and submit a traditional premarket notification [510(k)] for successful clearance from US FDA. The premarket notification [510(k)]… Organized by compliancetrainings | Type: webinar
Webinar on Extending Drug's Life

October 5, 2015 from 1pm to 2pm – Mississauga Description: This webinar will describe how a pharmaceutical company can prolong the life of a drug product. The high cost of time, money, and man-hours to develop a new pharmaceutical drug requires… Organized by compliancetrainings | Type: webinar
Webinar On Risk Management in Clinical Trials

October 5, 2015 from 1pm to 2pm – Mississauga Description : ICH Q9 – Quality Risk Management has been present as an FDA Guidance Document for almost 10 years, and this advocates the utilization of a risk assessment and then risk analysis methodo… Organized by compliancetrainings | Type: webinar
Webinar On Establishing an FDA-Compliant UDI System

October 5, 2015 from 1pm to 2pm – Online Description : This seminar is intended to help you effectively implement a unique device identification (UDI) system based on the final rules issued and published in federal register. Specifically, n… Organized by compliancetrainings | Type: webinar

Webinar On Root Cause Analysis

October 3, 2015 from 1pm to 2pm – Online Description : When you have a non-conformance in the laboratory, how do you approach it? Do you jump in and start treating the symptoms? Or do you stop to consider whether there's actually a deeper p… Organized by Compliance Trainings | Type: webinar

Webinar On Drug Master Files: New Implications under GDUFA

October 2, 2015 from 2pm to 2pm – Online Description : The Generic Drug User Fee Amendments of 2012 (GDUFA) were designed to speed the delivery of safe and effective generic drugs to the public and reduce costs to industry. A Drug Master Fi… Organized by compliancetrainings | Type: webinar
Webinar on Implementing an Internal Audit Program of QMA, Persisting to ISO 13485 and 21 CFR Part 820

October 2, 2015 from 1pm to 2pm – Online Description : This webinar is intended to help you adequately develop an internal audit program of a firm's quality management system (QMS) as required by ISO 13485 or 21 CFR Part 820. 21 CFR 820.22… Organized by compliancetrainings | Type: webinar

Seminar on The 3 C's of Audit Report Writing

October 1, 2015 at 9am to October 2, 2015 at 6pm – Courtyard by Marriott Capitol Hill/Navy Yard Overview: This 2-day session will appeal to beginners and experienced professionals who want to formulate great audit reports as well as executives and investors who need to unlock the valuable secre… Organized by John Robinson | Type: seminar
Seminar on Tougher Import Rules for FDA Imports in 2015 at Washington, DC

October 1, 2015 at 9am to October 2, 2015 at 6pm – Courtyard by Marriott Capitol Hill/Navy Yard Overview: FDA's and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of information and adherence to government procedures. F… Organized by John Robinson | Type: seminar

Get Ready For Your HIPAA Compliance Audit

September 30, 2015 from 10am to 11am – Online Event Overview: The webinar will concentrate on topics that HHS has announced will be the focus of the first round of "desk audits". They reflect significant areas of non-compliance revealed in the 2012 pi… Organized by Roger Steven | Type: webinar