Engaged. Knowledge. Application
GLP Training Workshops Boston
Event Details
Time: June 8, 2010 to June 10, 2010
Location: Doubltree Hotel - Boston/Waltham, MA
Website or Map: http://www.enkap.com
Phone: 561-795-2785
Event Type: training, workshop
Organized By: Terri Melvin
Latest Activity: Mar 22, 2010
Event Description
Click Here To View Workshop Brochure and Registration Form
Early Registration Discount: Register by April 21, 2010 and save 5%. Register for all three days before April 21, 2010 and save 10%
June 8-10, 2010 - Doubletree Hotel - Boston/Waltham, MA
Workshop Content
June 8, 2010
THE BRASS TACKS OF GLP: Practical Understanding of the Fundamentals as Never Before Explained
➢Control & Accountability - GLP Roles and Responsibilities
➢Clear Study Design & Objectives
➢Prevention of Contamination, Mix up and Deterioration
***REAL-LIFE GLP Scenarios***
➢Data Quality/Study Integrity
***JEOPARDY-STUDY INTEGRITY ACTIVITY***
➢Accurate Results/Study Summary/Conclusions
***REPORTING RESULTS AND CONCLUSIONS ACTIVITIES**
➢Study Reconstructability and Q&A
June 9, 2010
AMENDMENTS, DEVIATIONS, and UNFORESEEN CIRCUMSTANCES: The Good, The Bad, and The Ugly
➢GLP Studies - Welcome to the Real World
➢Amendment, Deviation, or Unforeseen Circumstance - That is the Question?
***HOW DID THIS HAPPEN?***
***PLAN FOR THE BEST, PREPARE FOR THE WORST - THREE STEPS FORWARD; TWO STEPS BACK***
***NOW WHAT? WHEN ALL ELSE FAILS - DOCUMENT***
➢Avoiding GLP Study Pitfalls
➢Wrap-up and Q&A
June 10, 2010
IMPLEMENTING AN EFFECTIVE GLP QUALITY SYSTEM
➢Conducting an Effective GAP Analysis: It All Starts Here!
➢How Wide is the GAP?
***IMPLEMENTATION PLANNING PHASE EXECUTION***
***THE GAME OF "REAL GLP" LIFE***
➢Executing the Plan
BUILDING (or REMODELING) AN SOP SYSTEM***
➢Project tracking: Milestones and Timelines - (How) Did We Get There?
Comment Wall
Contact enKap
enKap Terms and Conditions
enKap Terms and Conditions
All sales are final
Legal Disclaimer
This product and any of its enclosures, attachments or appendices, references to online information, conferences or preparations of materials in a variety of formats are created to provide you with accurate and authorative information concerning the subject matter covered. However, this product and any other ancillary items disseminated in connec-
tion with same are not necessarily prepared by a person licensed to practice law in a particular jurisdiction.
enKap, Inc. is not engaged in rendering legal advice, and this product is not a substitute for the advice of an attorney. If you require legal or other expert advice, you should seek
the services of a competent attorney or other professional.
enKap, Inc. necessarily is not, cannot and will not be liable for any claims, damages, or regulatory legal proceedings initiated as a consequence of you, the customer, modifying,
altering, adding to or deleting portions of any product initially provided by enKap, Inc.
Once any original document provided by enKap, Inc. to you, whether in print or electronic format, has been manipulated or customized by you, then the responsibility for the
document’s accuracy, correctness, and compliance are solely yours.
If any action, claim for damages, or regulatory proceedings is commenced against enKap, Inc. as a consequence of your alteration or modification, etc. of the document templates
or other originally provided materials, then and in that event, you agree to indemnify enKap, Inc. for such claims, and for any attorney’s fees expended by enKap, Inc. in connec-
tion with defense of same.
© copyright 2012 enKap
© 2012 Created by enKap.
