This two day interactive in-person seminar will provide participants the regulatory background and guidelines through all critical areas of GMP compliance. This course helps attendees understand the latest requirements and also provides them templates and examples to develop inspection ready documentation.
Deadline for abstracts/proposals: 17th January 2017
Organized By: Netzealous LLC
Keynote Speakers: Dr. Ludwig Huber
Chief Advisor - Global FDA compliance, Labcompliance
Chairman, presenter and panel discussion member at US-FDA Industry Training sessions and conferences
Served as team member of PDA's task forces "21 CFR Part 11", of US-FDA internal documents, and of the GAMP® special interest group on Laboratory Systems.
Presenter of the Year of the Institute for Validation and Technology
Director and chief editor of www.labcompliance.com, the global on-line resource fo
Conference Highlights: Day 1 Schedule
FDA Regulations and Requirements Overview
FDA 21 CFR Part 211 and 21 CFR Part 11
Most frequently cited FDA 483s and warning letters
Requirements overview from sampling to archiving
Quality system requirements, e.g., ICH Q10
The concept and practice of risk based compliance
Planning for quality and cGMP compliance
Developing and using a validation master plan
Scope, objectives and key elements of the master plan
Developing and using FDA compl
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