Date :
Place : United States, St petersburg
Website :http://bit.ly/1PR53NH
Contact Person:Event Manager
Description:
Course "Equipment, Facility, and Process Qualification and Validation - A Simple Top to Bottom Sustainable Approach" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Companies face many common issues and confusion when creating or revamping their validation programs. Some of these common issues are: Company has expertise in its process validation program but can never quite get is arms around the facility and equipment changes that require never ending equipment qualification (IQ, OQ, PQ)Deadline for abstracts/proposals : 1st December 2015
Organized By :NetZealous - GlobalCompliancePanel
Keynote Speakers : Jonathan M. Lewis Principal, Advanced Biomedical Consulting (ABC), LLC Jonathan M. Lewis Founding Partner, Reliant FDA Experts��...a Division of Advanced Biomedical Consulting, LLC, has over twenty-three years' experience in the areas of quality control/quality assurance (QA/QC), regulatory affairs, manufacturing, validation, project management, and executive management in both industry and consulting roles. Mr. Lewis has experience in the medical device, diagnostic, biopharmaceuti
Conference Highlights :Agenda: Day 1 Schedule: Lecture 1: Understanding the Basics of Validation • Regulatory References • Validation Terminology Lecture 2: The Components of a Sustainable Validation Program • Design Qualification • FATs and SATs • Commissioning • The Validation Master Plan • The Validation Project Plan • Standard Operating Procedures (SOPs) • Protocols • Reports • Additional Software Validation Documents Lecture 3: Other Programs that Feed the Validation Program
Venue :Courtyard St. Petersburg Downtown, 300 4th St N, Saint Petersburg, FL, United States
Check the event website for more details.