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ANALYTICAL METHODS:
TYPES OF ANALYTICAL PROCEDURES
ANALYTICAL METHOD DEVELOPMENT
ANALYSIS OF DRUGS AND METABOLITES FROM BIOLOGICAL FLUIDS
A CRITICAL REVIEW OF PHARMACOPOEIAL AND OTHER ADVANCED METHODS FOR
ESTIMATION OF DRUGS
DEVELOPMENT OF TECHNIQUES FOR QUANTITATIVE ANALYSIS OF ENDOGENOUS SUBSTANCES
OF MICRO-COLUMN LC-MS

WATER DETERMINATION BY KARL - FISHER METHOD
ANALYSIS OF FOOD ADDITIVES IN ETHICAL AND NON-ETHICAL FOODS

IR SPECTROSCOPY - A MODERN ANALYTICAL METHOD
CONJUGATED DIENES AND UV SPECTROSCOPY
(Pending...)
AUGER ELECTRON SPECTROSCOPY

MOLECULAR FLUORESCENCE AND PHOSPHORESCENCE

ISOLATION, IDENTIFICATION AND ESTIMATION OF ACTIVE PRINCIPLES AND EXCIPIENTS
FROM HERBAL PRODUCTS
(SEMINAR)
GENERAL THEORY OF pH, BUFFERS, ELECTRODES
AND CALIBRATION

MOBILE PHASE SELECTION DURING ANALYTICAL METHOD DEVELOPMENT

METHOD DEVELOPMENT AND VALIDATION BY USING HPTLC

THEORY AND PRINCIPLES OF CAPILLARY ELECTROPHORESIS
(Pending...)
PERFORMANCE VERIFICATION OF HPLC SYSTEM

QUANTITATIVE ANALYSIS BY HPLC

AFFINITY CHROMATOGRAPHY
CHIRAL SEPARATION METHODS

A REVIEW OF STEREOCHEMISTRY

TERMINOLOGIES FOR ANALYTICAL CAPILLARY ELECTROPHORESIS

CAPILLARY ELECTROPHORESIS

SOLID PHASE EXTRACTION (SPE)

LIQUID CHROMATOGRAPHY
(SEMINAR)
PROCEDURE FOR STANDARD SOLUTION PREPARATION

INTRODUCTION TO
IR, MASS AND NMR SPECTROSCOPY

GAS CHROMATOGRAPHY - MASS SPECTROMETRY

GENERAL PROCEDURES FOR HPLC COLUMN CARE

INTRODUCTION TO MASS SPECTROMETRY
PRINCIPLE AND THEORY OF MASS SPECTROMETRY

TANDEM MASS SPECTROMETRY (MS/MS)

MASS SPECTROMETRY
(SEMINAR)
RAMAN SPECTROSCOPY

CONTROL OF THE QUALITY OF ANALYTICAL METHODS

SYSTEM SUITABILITY TESTS FOR QUANTITATIVE CHROMATOGRAPHIC METHODS

FLOW INJECTION ANALYSIS

VALIDATION:
ANALYTICAL PROCEDURES AND METHOD VALIDATION
VALIDATION OF ANALYTICAL METHODS
VALIDATION OF ANALYTICAL PROCEDURES: METHODOLOGY
VALIDATION OF CHROMATOGRAPHIC METHODS

STARTING MATERIAL ANALYTICAL PROCEDURE VALIDATION
FINISHED PRODUCT ANALYTICAL PROCEDURE VALIDATION
BIOANALYTICAL METHOD VALIDATION

WHO GUIDE TO GMP REQUIREMENTS - VALIDATION
AIM OF QUALIFICATION AND VALIDATION (I.Q., O.Q.)
VALIDATION MASTER PLAN (VMP), DESIGN QUALIFICATION (D.Q.), INSTALLATION
QUALIFICATION (I.Q.) AND OPERATIONAL QUALIFICATION (O.Q.), NON-STERILE
PROCESS VALIDATION, CLEANING VALIDATION
PROCESS VALIDATION
CLEANING VALIDATION IN API MANUFACTURING PLANT

VALIDATION OF ASEPTIC PROCESSES
QUALIFICATION AND VALIDATION OF SOFTWARE AND COMPUTER SYSTEMS
GUIDELINES FOR THE VALIDATION OF COMPUTERISED SYSTEMS IN THE LABORATORY
STABILITY:
STABILITY STUDY – A REVIEW
STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS (ICH - Q1A)
PHOTO-STABILITY TESTING OF THE NEW DRUG SUBSTANCES AND PRODUCTS (ICH-Q1B)
BRACKETING & METRIXING DESIGNS FOR STABILITY TESTING OF DRUG SUBSTANCES AND
PRODUCTS (ICH - Q1D)
EVALUATION OF STABILITY DATA (ICH - Q1E)
GUIDELINE FOR RESIDUAL SOLVENTS (ICH - Q3C)
STABILITY TESTING OF BIOLOGICAL PRODUCTS (ICH - Q5C)
TEST PROCEDURES FOR ACCEPTANCE CRITERIA FOR NEW DRUG SUBSTANCE AND NEW DRUG
PRODUCTS (ICH - Q6A)
STABILITY DATA PACKAGE FOR THE REGISTRATION APPLICATIONS IN CLIMATIC ZONES - III
& IV
ASEAN GUIDELINE ON STABILITY STUDY OF DRUG PRODUCT

GUIDELINES:
ANDAs: IMPURITIES IN DRUG SUBSTANCES
BIO EQUIVALENCE STUDY OF GENERIC PRODUCTS
GOOD CLINICAL PRACTICE (GCP)
DOCUMENTS REQUIRED FOR GCP
GUIDELINES FOR SUBMITTING SUPPORTING DOCUMENTATION IN DRUG APPLICATION
WHO GUIDELINE ON PRE-APPROVAL INSPECTION
GOOD LABORATORY PRACTICES
(GLP)
GUIDELINE FOR AUDITING CLINICAL LABORATORY

GMP GUIDELINES FOR ACTIVE PHARMACEUTICAL INGREDIENTS (API)
cGMP FOR COMBINATION PRODUCTS
cGMP GUIDELINES FOR STERILE DRUG PRODUCTS MANUFACTURING
OUT OF SPECIFICATION (OOS) TEST RESULTS FOR THE PHARMACEUTICALS
WHO GUIDELINES OF STANDARDIZATION OF HERBAL RAW MATERIALS AND FINISHED
PRODUCTS
IND FOR PHASE - 1 STUDY OF DRUGS AND BIOTECHNOLOGICALLY DERIVED PRODUCTS

INDs - APPROACHES TO COMPLYING WITH cGMP DURING PHASE-1

ANDA GUIDE
FORENSIC TOXICOLOGY LABORATORY GUIDELINES

MISCELLANEOUS:
IMPORTANT TERMINOLOGY SPECIALLY FOR Q.A.
PHARMACEUTICAL CALCULATIONS OF DIFFERENT UNITS AND FACTORS

STATISTICAL DETAILS - DESIGN SELECTION

STATISTICS, PROBABILITY AND NOISE

CONCEPT OF COMBINATORIAL CHEMISTRY AND COMBINATORIAL TECHNIQUES
SOPs FOR CLINICAL INVESTIGATORS

CLINICAL PHARMACOKINETIC
DESIGN AND CONDUCT OF CLINICAL TRIALS
CURRENT CLINICAL STRATEGIES OF MEDICINES - 2001 EDITION

THE PATENT ACT - 2005 - AN AMENDMENT TO THE PATENT ACT - 1970

COMPLAINTS AND RECALLS
SELF INSPECTION
DOCUMENTATION
SCHEDULE M
DRUG AND COSMETIC ACT – SCHEDULE LIST AND CONTENTS
(
1,
2,
3 )
GMP TRAINING
QUALITY SYSTEM APPROACH TO PHARMACEUTICAL CURRENT GOOD MANUFACTURING
PRACTICE
STANDARD OPERATING PROCEDURES (SOPs) AND PROTOCOL
DISSOLUTION PROTOCOL
BIOBURDEN

GUIDE TO HIGH PURITY WATER SYSTEM
GENE TRANSFER VECTORS
CLONING VECTORS FOR EUKARYOTES

STANDARDIZATION OF SOME COSMETIC PRODUCTS
PARKINSON'S DISEASE HANDBOOK

GUIDE TO MOLECULAR WEIGHT DETERMINATION

PQA (SEM-I) PRACTICALS
MAT (SEM-I) PRACTICALS
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