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 COMMITTEEThe 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 PROCESSNo matter what you are designing, the design process is the same and can be divided into seven phases:
Taken from "Design Process: Established Need to Final Form" |
MEDICAL DEVICE PROCESS VALIDATION |
BROCHURE RELEASEThe Validation Week Puerto Rico Brochure is now available! Download it here. |
A TEN-STEP RISK MANAGEMENT PROCESS
Adapted from a paper written by Anne Greene and Kevin O'Donnell. Read it here. |
PROCESS VALIDATION QUIZZES |
SURVEY ON CONTINUED PROCESS VERIFICATIONA 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. |
EVOLUTION OF PROCESS VALIDATION |
BENCHMARKING86% 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 |
20TH ANNUAL VALIDATION WEEK |
PROCESS VALIDATION VIDEO SERIES
PAST BROCHURES |
VALIDATION WEEK COMPENDIUMS
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