Computerized Systems Auditing and Software Validation

Venue: Toronto

Location: Toronto, Canada

Event Date/Time: Sep 22, 2008 End Date/Time: Sep 23, 2008
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Description

Quality Assurance, Risk Management, and Regulatory Compliance for Pharmaceutical and Healthcare Manufacturers

A TWO DAY COMPREHENSIVE & INTERACTIVE COURSE, WITH CASE STUDIES & WORKSHOPS ON:

- Regulatory Expectations for Computer System GxP Compliance
- Preparing for an FDA Inspection and Review of Common 483’s
- Requirements for a Successful Validation Project
- Software Validation Methods, Design, Development, Verification
- Performing IQ/PQ/OQ Requirements and Documentation
- Validation for Off the Shelf (OTS) Software and Custom Programs
- Achieving Traceability in the Validation Process
- Meeting User Requirement Specifications (URS)
- Applying Risk Management and Risk Based Approach
- Change and Configuration Management Procedures
- Prioritization of Systems and System Maintenance Procedus
- Managing Spreadsheets, Production and Lab Equipment
- System-Level Validation Testing
- System Maintenance for Security
- Traceability and Archiving
- Strategies for Vendor Auditing
- Documentation Management

Interactive Sessions:

- Performing a Self Audit of GxP Computer Systems
- User Requirement Specifications (USR) Evaluation
- Validation for Laboratory Information Management Systems (LIMS)

Venue

Types