Regulatory Focus for Computer System Validation

This computer system validation training will provide the basic building blocks you will need to develop & maintain your company’s validation and compliance program. It will cover the practical entry requirements and operations, principles of risk-based computer system validation.

Why Should You Attend:

The FDA’s General Principles of Software Validation (GPSV), emphasizing how crucial requirements are to successful validation, recognizes that the requirements for a successful validation project are difficult, if not impossible, to create accurately and to an adequate level of detail in one pass.

The recognition that requirements are “defined, refined, and updated as a development project progresses” indicates that the FDA clearly understands that it is unlikely that a project team will be able to adhere strictly to a traditional waterfall life cycle management model.

This webinar will explain the criteria for software-based applications established by the FDA and other regulatory agencies, developed for use within the pharmaceutical, biological, and medical device industries. The session will provide the basic building blocks you will need to develop & maintain your company’s validation and compliance program. It will cover the practical entry requirements and operations, principles of risk-based computer system validation.

For Registration:

http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702703?channel=worldconf