Computerized System Validation (CSV)

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Event Date/Time: Feb 23, 2011 End Date/Time: Feb 24, 2011
Registration Date: Feb 23, 2011
Early Registration Date: Jan 17, 2011
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Description

Strategies for Achieving and Maintaining Part 11 Compliance in Today's Current Practices

About the Course

To echo modern computer technology and development techniques, computer validation practices need to be updated:

IPA is pleased to draw together recognized industry subject experts to address Today's current compliant practices on validation of computerized system and taking the attendees through effective processes on how to successfully managing, gathering, analyzing, specifying and documenting validation and for implementing the 21 CFR 11 regulation.

Practical examples, case studies and collaborative exercises will be dispersed into and between the presentations. In completion of this program, the delegates will gain valuable validation knowledge and tools to optimize the entire process and excel in their job.

During this two-day interactive training you learn about:

During this two-day interactive training you learn about:

Functional Requirements and Specifications
Detailed Design Specifications
Validation Plans, SOPs, Protocols and Reports
Installation, Operation, and Performance Qualifications (I/O/PQs)
Traceability Matrix
Testing Execution
Validation Summary Report
Risk Assessment Tools
Program Outline

Computer System Validation Regulatory Requirements
Computer Validation Process and Deliverables
Validation Plans and Master Validation Plans
Functional Testing (How much is enough?)
System Development Life Cycle (SDLC)
Risk-Based Validation of Computer Systems Used In FDA-Regulated Activities
Computer System Vendor Qualification, and Vendor Audit Checklist
Computer Infrastructure Security
Maintaining the State of Qualification
Workshops

Validating a Laboratory Instrument
Validating and Use of Excel Applications
Validation Program Design & Management

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