| September 5, 2012 |
Online Event
This FDA software validation Webinar/training will discuss how to self audit and ensure validation and software quality processes that will pass FDA inspection. Read more »
| June 14, 2012 |
Online Event
This webinar will present a methodology for system assessment, risk-analysis, 21CFR Part 11 compliance, remediation and inventory, along with templates and forms that attendees can modify for their own business. Read more »
| May 23, 2012 |
Online Training
This webinar will examine the existing and proposed requirements for the FDA’s DHF – including its derivative documents, the DMR and DHR. It will consider the MDD’s TF/DD requirements, and evaluate the documents’ differing purposes / goals. Read more »
| May 8, 2012 |
Online Training
Overview: There are a wide variety of risk management tools cited in ISO 14971, the medical device risk management standard.
However, most manufacturers are only using one tool, FMEA. The other tools are being ignored with a result that often does not meet the requirements of ISO 14971. Read more »
| March 23, 2012 |
Online Event
This 90-minute webinar on medical device quality assurance practices will review robust quality assurance principles and teach you techniques and lean methods to help you implement FDA Quality System Requirements. Read more »
| February 16, 2012 |
Online Event
The webinar will discuss the do’s and don’ts for using social media in marketing FDA-regulated products. Common issues, misconceptions, perceptions, and possible solutions will be discussed. The presentation will to familiarize you with the current FDA rules and help you plan for developments expected in the near future. Read more »
| February 8, 2012 |
Online Training
Expectations for meaningful hazard analysis, hazardous conditions, and documentation have always existed by regulatory agencies.
There is an increased awareness of the importance of design activities to support the production of safe and effective product. Product risk management is a required tool to drive and direct resource constrained product design, manufacture and validation activities in the company. Read more »
| January 18, 2012 |
Online Event
If you use software as part of your Production or Quality Management System (QMS) you must validate the software. This requirement is not the same as for software built into a medical device. Production and QMS software requirements are in 21 CFR§820.70(i). The most common occurrence of this kind of software involves an Excel spreadsheet. This webinar gives you practical advice on recognizing when this happens. Read more »
Online Event
Why Should You Attend:
Although the term, Quality Manual, is mentioned quite frequently in the pharmaceutical and medical device industries, are you aware that the quality manual has not always been included as a requirement in these regulations? Only in recent years has its valuable role been recognized as a tool that holds the quality system together. Read more »
| December 8, 2011 |
Online Event
Why Should You Attend:
Postmarket surveillance under section 522 of the Federal Food, Drug, and Cosmetic Act (the act) is one means by which the Food and Drug Administration (FDA) can obtain additional safety and/or effectiveness data for a device after it has been cleared through the 510(K), PMA, HDE or PDP process. Read more »