| August 8, 2012 |
Online Event
This Spreadsheet validation training explores strategies for recognizing when validation is required, how to achieve compliance and what documentation needs to be generated and maintained. Read more »
| September 5, 2012 |
Online Event
This FDA validation training will describe methods for planning and executing spreadsheet validations that satisfy FDA requirements. 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 »
| 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 »
| May 23, 2012 |
Online Event
This webinar on validating legacy computer systems will give a good understanding of FDA and EU regulatory requirements for validation (retrospective validation) and provide tools for effective implementation. Read more »
| May 23, 2012 |
Online Event
This FDA warning letter Webinar/training will discuss what to do to avoid additional software related compliance along with the response steps where the citations that directly or indirectly include automated system. 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 »
| May 30, 2012 |
Online Event
This 21 CFR Part 11 training will analyze the regulations and provides concrete guidance on compliance for Electronic Medical Records Read more »
| June 18, 2012 | to | June 20, 2012 |
Mumbai, India
Overview: Each lecture will be 90 min in length. There will be morning and afternoon breaks of 30 min each which will be reduced to 15 min, if needed to accommodate long lectures. Lunch will be at least 1 hr in length.
The instructor will be available for questions and discussions during all breaks and lunches and will also be available for a minimum of 30 min at the end of each day. 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 »