Past Events (3,027)

Webinar On Medical Device Laws and Regulations in Asia: China, Hong Kong, Japan and Korea

December 15, 2014 from 1pm to 2pm – Online This webinar is intended to help you get familiar with medical device laws and regulations in Asian countries: China, Hong Kong, Japan, and Korea. The medical devices are currently one of the fastest… Organized by Compliance Trainings | Type: webinar

Webinar On Annual Reports for Approved PMAs

December 11, 2014 from 1pm to 3pm – Online This webinar describes the information required by FDA to be submitted in a PMA annual report. The webinar also discusses FDA recommendations for level of detail the applicant should provide in the P… Organized by Compliance Trainings | Type: webinar

Webinar On FDA proposed changes to ISO 13485: 2015 and Medical Devices Quality Management Systems

December 9, 2014 from 1pm to 2:30pm – Canada Description : ISO 13485:2015 - What’s coming? Understand proposed changes being worked on by the ISO technical committee for updating the ISO 13485:2003. Awareness of the current requirements and pro… Organized by Compliance Trainings | Type: webinar
Webinar On FDA Inspections : Managing the Myth and the Reality

December 9, 2014 from 1pm to 2pm – Online FDA may inspect firms at a reasonable time, within reasonable limits and in a reasonable manner. Whether or not an inspection appears reasonable depends on a person’s point of view. FDA investigator… Organized by Compliance Trainings | Type: webinar

Webinar On Managing Product Recalls in Accordance with Part 806

December 4, 2014 from 1pm to 2pm – Online It is inevitable that eventually a device manufacturer will need to execute a correction or market-withdraw for a medical device. The actual process of managing a market-withdraw is time consuming; a… Organized by Compliance Trainings | Type: webinar

Webinar On DeNovo Classification Process

November 24, 2014 from 1pm to 3pm – Online This webinar provides information on FDA’s DeNovo classification process. The webinar explains how a device classified as a Class III device but has the risk level of a Class I or II device may be do… Organized by Compliance Trainings | Type: webinar

Webinar On Establishing a Robust Complaint Management System

November 20, 2014 from 1pm to 2pm – Online Lack of an effective complaint management system is one of the more frequent Form 483 observations cited during FDA device establishment inspections. In fact, failure to process complaints in a timel… Organized by Compliance Trainings | Type: webinar
Webinar On Pharma Graphics

November 20, 2014 from 1pm to 2pm – Online This webinar will guide on how to effectively use Visual Displays of Data to rapidly discover, understand, and effectively communicate results. Effective collection, analysis and communication of da… Organized by Compliance Trainings | Type: webinar

Webinar On 21 CFR 11 Compliance for Excel Spreadsheets

November 18, 2014 from 1pm to 2:30pm – Online In Dec. 2010, the FDA has stepped up enforcement for 21 CFR 11 compliance with spreadsheets being considered as low hanging fruit for FDA inspectional findings. Spreadsheet Applications such as MS Ex… Organized by Compliance Trainings | Type: webinar

Webinar On Best Practices for 510(k) Drafting and Submission: Dos and Don'ts

November 17, 2014 from 1pm to 2pm – Online From this webinar you will learn best practices for adequately putting your 510(k) together for your successful submission to the FDA, compliant with the FDA’s eCopy and RTA policy. This session will… Organized by Compliance Trainings | Type: webinar