| September 5, 2012 |
Online Event
This FDA validation training will describe methods for planning and executing spreadsheet validations that satisfy FDA requirements. Read more »
| July 11, 2012 |
Online Event
This GAMP® 5 training/Webinar will discuss on the GAMP® software validation model and the defined process of GAMP® 5 as it applied to FDA software validation. Read more »
| August 22, 2012 |
Online Event
This FDA Software Validation and Verification training/webinar will review the validation planning process with particular emphasis on avoiding six common pitfalls. Read more »
| May 27, 2012 |
Online Event
This Software Validation training webinar will discuss how to approach Strategic software Validation planning so as to satisfy FDA by complying to new enforcement initiative by FDA. Read more »
| May 15, 2012 |
Online Event
This webinar will explain Design Control, what it means, and how to incorporate it into the design and construction of a new facility or a renovation. Read more »
| July 25, 2012 |
Online Event
This FDA Inspection training provides concrete strategies for planning remediation projects.
Why Should You Attend:
Today’s manufacturing and quality environments are highly automated and computerized. Manufacturers facing FDA pre-approval inspections (PAI) as well as those who will be re-inspected following inspectional observations (FDA-483), warning letters and other compliance issues can expect FDA to pay increasing attention to automated manufacturing systems and computerized quality systems. 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 »
| March 13, 2012 |
Online Training
This webinar will give a good understanding of FDA and international expectations for auditing computer systems and provide steps for cost-effective implementation.
Auditing of computer systems is important to verify compliance of the systems with regulations and internal standards. When done right, audits can help to improve quality of computer system operation and uptime. Read more »
| April 4, 2012 |
Online Event
This excel validation training/ webinar will demonstrate how to design spreadsheets for part 11/GxP /SOX/HIPAA, document planning, specifications, installation, testing and changes to meet FDA requirements. Read more »