Pre-Recorded CD Webinar
Approximately 90 minutes in length, Self Examination and Answer Key Included
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
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
- Configuration Management
- When do I need to do all this?
- How do I “maintain the qualified state” and what does that mean, anyway?
Order On-Line to Own This CD Webinar: $195.00