Validation Week

VALIDATION APPROVAL COMMITTEE

The validation approval committee is the internal group that approves all validation documents. However, across different companies, what constitutes a validation approval committee often differs. The validation approval committee is the partner of validation in the sense that they must review validation documents with the perspective of a regulatory auditor.

Read "3 Foundations of a Successful Validation Approval Committee"

THE LIFECYCLE APPROACH

SEVEN-PHASE DESIGN PROCESS

No matter what you are designing, the design process is the same and can be divided into seven phases:

1. Defining the Design Problem
2. Conceptual Design
3. Conceptual Evaluation
4. Detail Design
5. Design Generation
6. Evaluation for Function and Performance
7. Turn Over to Customers

Taken from "Design Process: Established Need to Final Form"

MEDICAL DEVICE PROCESS VALIDATION

BROCHURE RELEASE

The Validation Week Puerto Rico Brochure is now available! Download it here.

A TEN-STEP RISK MANAGEMENT PROCESS

1. Document Specific Information on the Risk Management Exercise Being Undertaken
2. Define the Risk Management Team
3. Review the Default Definitions Provided for Negative Event Probability, Severity, and Detection
4. Identify Potential Negative Events
5. Risk Evaluation - Is the Risk Acceptable, Unacceptable, or Intolerable?
6. Risk Evaluation - Is the Risk Adequately Controlled
7. Risk Control
8. Qualification and Validation
9. Document Action Items
10. Risk Communication and Continuous Improvement (Periodic Review) Activities

Adapted from a paper written by Anne Greene and Kevin O'Donnell. Read it here.

PROCESS VALIDATION QUIZZES

SURVEY ON CONTINUED PROCESS VERIFICATION

A research team based at the Dublin Institute of Technology (DIT), conducted a recent industry survey to assess industry's current range of process monitoring activities and level of implementation of continued process verification programs.

Read the Survey Results | Register | Download Brochure

EVOLUTION OF PROCESS VALIDATION

(click to enlarge)

BENCHMARKING

Taken from a survey published in JVT. Read it here.

VALIDATION WEEK PUERTO RICO

20TH ANNUAL VALIDATION WEEK

PAST BROCHURES

VALIDATION WEEK COMPENDIUMS

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