Training Course Syllabus:

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

Time: 11:30 AM PST | 02:30 PM EST

Duration: 90 Minutes

Instructor: James Carron

Description:


In the pharmaceutical industry and many other industries it is recognized that there is an increasing dependence upon automation. As a result, many companies are adopting different approaches to keeping their Enterprise systems compliant. A company must have a policy and or procedure(s) that define a code of conduct. The Quality Systems Regulation 21 CFR part 820, which was originally a regulatory requirement for the medical device industry, was instituted across all of FDA regulated industries.

Many companies fail to engage the quality system in day to day business practices. As a result, the validation of non-related business processes may result in regulatory liabilities. In addition, by not engaging the quality system, the validated system may not be governed by adequate change control. IT applications and Infrastructure when automating existing Predicate rules under FDA regulation, are required to undergo validation, utilizing a lifecycle approach.

Why Should you Attend:

The international marketing 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 professionals as well as quality and compliance executives should 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. Many companies are utilizing Enterprise platforms to ensure that they are compliant with localized Regulatory requirements when entering into new regions and markets.

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.

Objectives of the Presentation:

Objectives of the presentation are to discuss about:

• Incorporation of ICH Q8 and OCH Q10 into projects


• 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

Seminar Summary:

In the pharmaceutical industry and many other industries it is recognized that there is an increasing dependence upon automation. As a result, many companies are adopting different approaches to keeping their Enterprise systems compliant.  (see full course description)

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