1,295.00 (Seminar for One Delegate)
Sale Date Ended
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.
Companies face many common issues and confusion when creating or revamping their validation programs. Some of these common issues are:
Well, the answers to these and many, many more typical questions are now available in this simple to understand, yet detailed training session designed to help manufacturers of FDA regulated products build (or rebuild) a sustainable validation program.
Why should you attend?
Attend this FDA validation seminar to get deep knowledge about:
Lecture 1: Understanding the Basics of Validation
Lecture 2: The Components of a Sustainable Validation Program
Lecture 3: Other Programs that Feed the Validation Program
Lecture 4: Equipment, Utility, and Facility Qualification
Lecture 5: Process Validation
Lecture 6: Software Validation
Lecture 7: Time and Costs Associated with Validation
Lecture 8: Responding to Audit Findings Associated with Validation
Lecture 9:Welcome and Day 1 Reinforcement
Lecture 10: Practical Application # 1 -Equipment Qualification
Lecture 11:Practical Application # 2 -483 Responses
Lecture 12:Closing Comments
Individual/Open Q&A Session
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, biopharmaceutical, pharmaceutical, cosmetic, nutritional supplement, food, and animal food industries.
Prior to founding Reliant FDA Experts, Mr. Lewis worked for KMI/PAREXEL, a regulatory compliance and validation consulting firm, in increasing roles of responsibility from an entry-level Validation Engineer to an Associate xDirector of Consulting. He has worked at RPScherer (Cardinal Health), a contract and proprietary solid oral dose pharmaceutical manufacturing facility, as the QC/Validation Manager. In addition, he has worked at Telectronics Pacing Systems, a medical device manufacturer, in Sterility Assurance.
Location: St. Petersburg, FLDate: December 3rd & 4th, 2015Time: 9 AM to 6 PM
Venue: Courtyard St. Petersburg Downtown
Address: 300 4th St N, St Petersburg, FL 33701, United States
Price: $1,295.00 (Seminar for One Delegate)
Until November 15, Early Bird Price: $1,295.00
From November 16 to December 01, Regular Price: $1,495.00
NetZealous LLC - DBA GlobalCompliancePanel
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA
USA Phone: 1-800-447-9407
Registration Link - http://bit.ly/1PR53NH