PHARMA CONCEPTS

CLEANING HOLD TIME STUDIES

THE STORY OF NITROSAMINE IMPURITIES & VALSARTAN RECALLS

ANALYTICAL METHOD & ITS SUITABILITY

PROCESS VALIDATION

AUDIT TRAIL AND ITS IMPORTANCE

OUT OF SPECIFICATION RESULTS

DEVIATION MANAGEMENT

CHANGE MANAGEMENT SYSTEM

pH

STABILITY STUDY

8D– PROBLEM SOLVING APPROACH

CLEANING VALIDATION

a) CLEANING VALIDATION – ORIGIN

b) CLEANING VALIDATION – ACCEPTANCE LIMITS

c) CLEANING VALIDATION – BRACKETING – WORST CASE RATING

DATA INTEGRITY – ALCOA+

ROOT CAUSE ANALYSIS - SYSTEMATIC APPROACH

COMPUTERIZED SYSTEMS – LIFE CYCLE MANAGEMENT