Validation Week

ARTICLES FROM REGULATORY AGENCIES

US Food and Drug Administration
United States Pharmacopeia
 American Society for Quality Irish Medicines Board
Canadian Food Inspection Agency AAHRPP

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.

Validation Week Puerto Rico

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

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Evolution of Process Validation Thumbnail

BENCHMARKING

86% of solid dosage manufacturers statistically trend their data.
29% of solid dosage manufacturers have procedures to show how trending and calculations are to be performed.
53% of Pharma use risk analysis to determine the monitoring and sampling requirements of process parameters and quality attributes.

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

VALIDATION WEEK PUERTO RICO

Validation Week Puerto Rico

20TH ANNUAL VALIDATION WEEK

20th Annual Validation Week

PROCESS VALIDATION VIDEO SERIES

PAST BROCHURES

VALIDATION WEEK COMPENDIUMS

 

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