Many
of our recently held briefings are available on audiocassette files.
Visit our Tapes Library for our highly regarded series
on:
|
 Tapes
Library
Computer
Validation: FDA's Emphasis on Risk Assessment in
Validation |
|
| Speaker: |
David
Dills, Director of Regulatory Compliance and Validation
Services, Focus Compliance and Validation Services |
| Date
of Briefing: |
November
9, 2004 |
| Approximate
length: |
One
hour |
|
Description: |
Worldwide
regulatory compliance and validation expert, David Dills,
presents a proven framework that will enable you to assure
that your validation program is covering all the key areas
to withstand the rigor of FDA's Risk Assessment approach
as well as a company's internal auditors. |
| Price: |
$225
Tape |
| ttttttttttttt
|
Go
to the
Order Form
Click
here to see briefings from 2002. |
Tapes
Library
Computer
Validation: Programmable Logic Controllers |
|
|
Speaker: |
Kevin
Martin, Vice President, CimQuest |
|
Date
of Briefing: |
April
20 , 2004 |
|
Approximate
length: |
One
hour |
|
Description: |
This
practical presentation by Kevin Martin, Vice President
at CimQuest, will explain how Programmable Logic
Controllers (PLCs) work, how they differ from traditional
computers, and how to best validate them. |
|
Price: |
$195
Tape |
|
ptovvvvv |
Go
to the
Order Form |
|
Tapes
Library
Computer
Validation: Change Control |
|
|
Speaker: |
Kenneth
Christie, VTS Consultants |
|
Date
of Briefing: |
April
13 , 2004 |
|
Approximate
length: |
One
hour |
|
Description: |
Change
Control (CC) is important because it helps
demonstrate that controlled validated systems
can be used to minimize or eliminate testing
associated with re-qualification and to
reduce time and costs of contractor services.
Learn this and much more about CC with Kenneth
Christie of VTS Consultants.
|
|
Price: |
$195
Tape |
|
rrrrrrrrrrr |
Go
to the
Order Form |
|
|
|
|
Archive
Library
Computer
Validation: Configuration Management |
|
| Speaker: |
J.
Scott Hodges, Ph.D., Project Manager, Stelex |
| Date
of Briefing: |
March
23, 2004 |
| Approximate
length: |
One
hour |
|
Description: |
Configuration
management (CM) is more critical than ever, particular for software,
says J. Scott Hodges, Ph.D., project manager at Stelex. Change
control should be viewed as part of a larger system of CM that
monitors systems and equipment. He notes that many QA/QC people
use CM and change control interchangeably but “CM actually
helps identify items that fall under the change control system.”
Dr. Hodges further notes that the Rx industry faces higher costs
for configuration changes than industries with less regulation,
citing security issues among other examples. Hodges warns that
“improperly managed change control can have disastrous
results from both regulatory and business perspectives.” |
| Price: |
$195
Tape |
| ttttttttttttt
|
Go
to the
Order Form |
Archive
Library
Computer
Validation: Software Testing to Reveal Errors |
|
| Speaker: |
Walter
McClenney, Validation Directory, SEC Associates |
| Date
of Briefing: |
March
17, 2004 |
| Approximate
length: |
One
hour |
|
Description: |
Computer
system and software validation should not rely on methods
that avoid errors but reveal them, according to Walter
“Neil” McClenney, Validation Director, SEC
Associates. “Errors are there and that is just a
rule of software development. It’s a question of
your company’s metrics for success and validation
priorities,” believes McClenney. Software testing
should stress the software’s functionalities by
going above and beyond execution within known boundaries
and limits. |
| Price: |
$195
Tape |
| ptovvvvv |
Go
to the
Order Form |
|
Archive
Library
Computer
Validation: Automated Compliance Systems |
|
| Speaker: |
Alberto
Correia, Vice President, VelQuest |
| Date
of Briefing: |
February
24, 2004 |
| Approximate
length: |
One
hour |
| Description: |
Manufacturers
planning to update their computer systems -- whether
to be compliant with Part 11 or GMPs -- should
consider systems that provide automated trending
reports as well as annotations, attestations,
and “reason codes.” These are among
the suggestions made by Alberto Correia, vice
president of VelQuest, who also says that automated
compliance software can maintain an audit trail
for individual steps and records, giving users
more flexibility for tracing and reviewing data.
|
| Price: |
$315
CD |
| rrrrrrrrrrr |
Go
to the
Order Form |
|
|
|
Page
last updated
October 16, 2006
Washington Information
Source © Copyright 2006
208 South King Street, Leesburg, VA 20175
Tel: (703) 779-8777 . Fax: (703) 779-2508
service@fdainfo.com .
www.fdainfo.com/expertbriefings/
This site has been accessed:
times.
|
