Quality Systems Approach for Validation and Maintenance of a Global ERP System

Why Should You Attend:

The international growth of the pharmaceutical, biotechnology and medical device industries is becoming more common place. The international regulatory landscape is becoming more complex on a daily basis. As a result, it behooves IT professional as well as quality and compliance executives to have a common approach in rolling out their product line to new countries and regions that have their own requirements for importation, sales and distribution, and inventory control of regulated product as well as ensuring that a company is abiding by applicable government pricing practices. The utilization of the Global Enterprise Resource Planning (ERP) system under the appropriate quality system oversight can ensure that there is a compliant automated system that ensures governance controls regardless of where a company may choose to do business.

This webinar will focus on an SAP implementation utilizing a quality systems approach for the implementation phase and ongoing maintenance program to facilitate a system development lifecycle to maintain the application in an ongoing validated state. It will detail how to implement an enterprise solution by integrating a company’s existing quality system, thus saving time and money during an implementation project as well as on-going maintenance of the enterprise solution during change management.

Areas Covered in the Webinar:

• Selection Phase
• Analysis Phase
• Initiation Phase
• Design Phase (largest phase and most important phase)
• Validation Phase
• Test Phase
• Cutover(Go-live strategy)
• Change Control
• Functionality design fixes
• Upgrades
• Business expansions

Who Will Benefit:

• IT Project Managers
• IT Executives
• Supply Chain Executives
• Quality Assurance Executives
• Regulatory Compliance Associates and Managers

Instructor Profile:

James Carron, has a BS in Chemistry/ Mathematics from Missouri State University who has over 26 years of industry management experience including Validation, Quality Control, Quality Assurance, and Research and Development, and Supply Chain. His experience includes pharmaceuticals (aseptic and solid dose), medical devices, and biotech products.

Most recently spent the last six years doing the Quality oversight for Amgen SAP implementation. Currently is an independent consultant in the areas of compliance, validation, Quality assurance and Quality control as well as cost containment.

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