WCQTI COURSE SCHEDULE -Fall 2010
Hood River, Oregon
-
GLPs 101
Oct 19
- GLPs for Study Directors and Monitors
Oct 20-21
- GLPs in the Real World
Oct 26-27
GLP TRIPLE PLAY* - A UNIQUE TRAINING OPPORTUNITY
Washington DC
probably late May early June in the Washington
DC area. - Watch for details
- Day 1 - Advanced GLP Issues - will be facilitated by Debi Garvin MS RQAP-GLP and will include the latest GLP issues such as managing multi-site studies, monitoring contractors, developing protocols that mitigate and minimize risks when conducting multi-site studies and the latest issues/findings of FDA investigators.
- Day 2 - Validation and Part 11 - Monica Cahilly MS RQAP-GLP, a leading expert in Part 11 and Computer Systems Validation will discuss latest standards, such as Red Apple II, as well as current regulatory trends, such as an increasing focus on electronic data integrity and presenting in-depth but understandable solutions to these issues.
- Day 3 - GLPs/GCP in Bioanalytical Lab - Chris Tudan Ph.D. , shares his in-depth knowledge in the field of bioanalytical chemistry. Dr. Tudan incorporates current guidance's, industrial standards and white papers in presenting a very technical overview of regulatory requirements in method validations and describes method development/validation considerations to ensure robust and GLP/GCP compliant sample analysis. (see course curriculum)
May register for 1-3 days.
Reasonably priced in-house customized seminars are also available. Please
contact De bi Garvin at debi@pacrimqa.com or 541-352-7120 for details. .