Who Will Benefit:

This training solution will benefit professionals in the following industries:
Medical Device, Pharmaceutical, Human Tissue, Biotechnology.

In departments such as:
QA/QC/RA, Manufacturing/Operation, Information Systems, Research and Development, Legal

With job functions:
Department managers and supervisors, QA/QC/RA specialists and engineers, IT specialists, Manufacturing and R&D engineers, Chemists, Scientists, Formulators, Documentation specialists, Laboratory personnel,  Auditors, Technicians

Course Description 
Software Validation has come under intense scrutiny by the FDA in recent years. This course will examine the current industry/FDA environment and will give you tools for survival; it will provide an introductory guide to planning and preparing for software validation and includes a discussion of the control of the entire “software lifecycle.” Requirements for software specifications, Validation Master Plans, qualification protocols, test scripts, deviation handling, qualification reports, configuration management and “maintenance of the qualified state” are discussed. Further, this course provides “content understanding” so important for auditing software development and validation activities as required in today’s FDA regulated industry environment.

	Background-What is Software Validation and what are the regulatory requirements?
	Why do I need to validate software and what software must be validated?
	What is the software lifecycle and why a lifecycle approach?
	Guidance: US FDA, GAMP, ISO
	Can I “scale” validation activities to suit the complexity /novelty of the system?
	Software Specifications: requirements definition and design documentation
	Risk Management considerations
	Validation Planning
	Protocols, Test Scripts, recording results, handling deviations
	Traceability Analysis
	Reports
	Configuration Management
	When do I need to do all this?
	How do I “maintain the qualified state” and what does that mean, anyway?