Upcoming GLP Training Workshops  Click here to register

March 18, 2008              GLP Training  (presented by Celeste Rose, RQAP-GLP) 

This one-day  workshop is designed to provide a thorough understanding of the FDA, EPA and OECD GLP requirements and responsibilities involved in the conduct of GLP studies.  The GLP Regulations (21CFR Part 58, 40 CFR Part 140 and 792) as well as OECD GLP Principles will be covered.  Participants will become familiar with the GLP regulations and principles to better understand why GLP requirements are so important and as well as to know “where it is written”.   “Real-life” examples and scenarios  will be used to convey key points.  The workshop will stress study compliance and the importance of record-keeping, good documentation practices, and study reconstructability.  This course would benefit persons new to the GLP environment as well as in in-depth refresher for those experienced in the conduct of GLP studies.      Click here for more details...

March 19, 2008              Study Director Training (presented by Celeste Rose, RQAP-GLP)

This one-day workshop is designed to provide the participant with a thorough understanding of the GLP requirements and responsibilities of the Study Director role, as well as soft skills and writing skills which are key for effective quality study conduct.  As the “single point of study control”, the Study Director role is a critical role in the conduct of GLP studies. The session will cover study compliance and the importance of good documentation, effective writing, and study reconstructability.  This workshop will benefit persons currently serving in the role as Study Director and those who may advance to role of Study Director. This course also in beneficial to Managers and QA professionals who would like to get a better understanding and appreciation of the role and responsibilities of the Study Director.  This session has been presented several times by Celeste Rose at the Society of Quality Assurance annual conference training workshops.  Attendees have found this workshop to be extremely beneficial.    Click here for more details...

April 21, 2008                 Study Director Training (presented by Celeste Rose, RQAP-GLP)

Workshop  to be presented  2008 - SQA Annual Pre-conference Training - Memphis, TN.
For more information visit www.sqa.org

Past GLP Training Workshops Presented by Celeste Rose

Study Director Training
2006 SQA Fall Ed Comm Training – Boston, MA
2007 SQA Annual Pre-conference Training – Austin, TX
2007 SQA Fall Ed Comm Training – Salt Lake City, UT

Basic GLP Training
2006 MWSQA Conference – Indianapolis, IN

Study Quality and Study Compliance.  Are They One in the Same?
Session presented at 2006 SQA Annual Meeting – Phoenix, AZ

Quality Study Direction  ½ Workshop
2005 MWSQA Fall Conference – Kansas City, MO

GLP Training for Study Directors ½ Workshop
2005 MWSQA Spring Conference – Toledo, OH

Design & Implementation of a Product Specification/Certificate of Analysis (C of A) Computerized System
Session presented at 2004 MWSQA Conference – St. Louis, MO

 

For more about our workshops email: Workshops@rosetechconsulting.com

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RoseTECH Consulting, Inc.

Professionals Who Understand the Science Behind the Quality Assurance

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