DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "Computer System Validation - 7 Courses to Boost your Knowledge" webinar to their offering.
The basic concepts of computerized system validation originated in the 1960s, with the Department of Defense and NASA. Validation of systems became a growing issue within the pharmaceutical industry during the late 1980s and early 1990s, as the use of computerized technologies became commonplace in the research and manufacturing of drug products.
The FDA issued a series of regulations and guidelines to define regulatory expectations for computerized system validation. In today's environment, virtually all aspects of research and manufacturing are conducted using computerized systems, yet the planning, conduct, and necessary controls for validation of these systems remains problematic for many companies and industry professionals.
- Computerized System Validation: Basic Concepts
- Computer System and Software Validation
- Best Practices for Documenting a Computer System Validation Process
- Applying Computer System Validation to Mobile Applications
- Validation and Use of Cloud Computing in FDA Regulated Environment
- Software Validation-Avoiding FDA Warning Letters and Consent Decree
- Systems Validation Made Easy
Who will benefit?
- Project/Strategic Management
- Quality Assurance Staff
- IT Staff
- Operations Staff
- Quality Assurance Managers/Personnel
- Regulatory Managers/Personnel
- Manufacturing Managers, Supervisors & Personnel
- Senior Management Executives (CEO, COO, CFO, etc.)
- Project Managers
- Information Technology Analysts
- Clinical Data Managers and Scientists
- Analytical Chemists
- Compliance Managers
- Automation Analysts
- Computer System Validation Specialists
- GMP Training Specialists
- Everybody responsible for FDA compliance of computer systems
- Managers from purchasing, documentation and operations
- GLP/GMP/GCP Auditors
- T/QA personnel
For more information visit http://www.researchandmarkets.com/research/xk5jmq/computer_system