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Study Materials ...

 

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