Change Control

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Location: -

Event Date/Time: Dec 07, 2010 End Date/Time: Dec 09, 2010
Early Registration Date: Nov 15, 2010
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FDA-regulated industries are required to establish a Change Control procedure that improves and maintains product quality, efficacy and safety. As part of the cGMPs under 21 CFR Parts 210-211, pharmaceutical companies are required to control any change to established processes – meaning the change has to be recorded, reviewed and approved by the QA/QC unit

IPA is pleased to invite you to you this well designed and developed seminar that provides a dsolid road map for establishing a robust Change Control program. This a two-day event that brings together industry experts and regulatory representatives who will share their experiences in Change Control processes from the manufacturing to laboratory through as well as suppliers with our audience. Participants are encouraged to take advantage of this well orchestrated seminar, workshops, and case studies program, This event is directed towards the pharmaceutical, biotech and medical device, and allied industries' professionals.

Program Outline:
Understanding and Meeting Regulatory Requirements and Expectations for Change Control
Optimizing Change Control Program
Planning and the Initiation of a Change Proposal
Evaluation of the Change Proposal - Change Control organizations
Change Control Implementation
Change Control Documentation Requirements
Essential Tools for Establishing a Robust Change Control Program
Developing a Harmonized Change Control Process
Implementation and Verification of the Global Change Control Process
Scope for Your Change Control System
Post Implementation — Monitoring and Maintaining a Change Control Program
Case Study

Implementing Change Control During and After Validation


Measuring the Efficacy of Change Control
How to Manage Changes in the Laboratory
Change Control — A Key Element of a Quality System
Risk Management