Date: Mon, 19 Oct 1998 13:47:30 -0400
Reply-To: Joshua Sharlin <jsharlin@PIPELINE.COM>
Sender: "SAS(r) Discussion" <SAS-L@UGA.CC.UGA.EDU>
From: Joshua Sharlin <jsharlin@PIPELINE.COM>
Subject: Class on FDA Required SAS Validation
Content-Type: text/plain; charset="us-ascii"
This is an update to the notice I posted about 5 weeks ago.
1) The London SAS Validation class dates are Dec 8 and 9, 1998.
The dates in the Sept posting were wrong.
2) The Nov 12 and 13 class in San Diego will be held at the
Holiday Inn on the Bay at 1355 N Harbor Drive.
This 2-day how-to class explains each step in validating a SAS program and is
intended for technical managers responsible for creating SAS code and QA
professionals responsible for auditing SAS development. The class covers;
1. How to audit SAS programs
2. Ways to design and document testing
3. Methods of designing and implementing SAS programs
4. The integration of SAS validation into daily programming
5. What the FDA teaches their inspectors
6. How validation can reduce FDA approval time
The class is based on the instructors' every day experience in
performing validation in the pharmaceutical industry. Course notes
include SAS programs that help perform validation and model
SOPs for each step in validation process.
Upcoming course dates are
Nov 12 and 13, 1998, in San Diego, CA, at the Holiday Inn on the Bay
Dec 8 and 9, 1998, in London, England. Univ of London Computing Center
The class will be taught by R. L. Chamberlain, Ph.D. (an industry validation
expert) and Joshua Sharlin, Ph.D. (a former FDA reviewer and SAS Quality
Previous attendees have been from Pfizer, Amgen, Genentech, Parke Davis,
Glaxo Wellcome, Searle, Baxter Healthcare, Covance, Quintiles and Novartis.
To register call 703-803-1080 (9 to 4:30 EST) or complete the form at
www.sasvalidation.com. For more information about course topics
Comments from attendees:
“Excellent insight into FDA reviewers’s requirements.”
“I can write SOPs based on the course notes. I would recommend
the course to many of my co-workers.”
"Having the perspective of a former FDA reviewer and someone who has
industry experience really improves the quality of the course. I think all
programmers, statisticians as well as managers of both should be
required to take this course.”