top of page

Choose the Plan for You

I offer coaching, consulting, and support for your personal and professional development.

  • Hands On eCTD Program 1st Inst: BATCH 6

    3,000₹
    Valid for 12 months

    • US UK EU JAPAN (4 COURSES)

      1,999₹
       

      • US UK RUSSIA LATAM CERTIFICATION

        1,499₹
         

        • US, EU, UK, LATAM DRA (4 COURSES)

          1,999₹
           

          • PHARMA LEADERSHIP LAUNCHPAD

            7,999₹
             

            • US, UK, CHINA, RUSSIA, LATAM

              1,999₹
               

              • CV, STABILITY, QMS, E&L, STAT, IMPURITY

                1,999₹
                🔥Grab 6 Courses Worth ₹25,994 for Just ₹1,999🔥 📍 1. Cleaning Validation 📍 2. Stability Study 📍 3. QMS Mastery 📍 4. Extractables & Leachables 📍 5. Statistics in Analytical Chemistry
                 
                • 📍 1. CLEANING VALIDATION
                • ✔️Cleaning Validation History
                • ✔️Cleaning Validation Process
                • ✔️Cleaning Levels
                • ✔️Bracketing Approach
                • ✔️Worst Case Rating
                • ✔️How to Calculate MACO
                • ✔️How to Finalize MACO
                • ✔️MACO as per HBEL
                • ✔️Decoding the Calculation of MACO by HBEL
                • ✔️Sampling Techniques (Swab, Rinse)
                • ✔️Defining Swab Limit & Rinse Limit
                • ✔️Defining Concentration of Residue Standard & Sample
                • ✔️Most Difficult to Clean – Lowest Limit Approach
                • ✔️Direct Testing Vs. Indirect testing for Cleaning Verificat
                • ✔️FDA 483 Related to Cleaning Validation
                • ✔️Swab Method Validation
                • ✔️Glassware Cleaning Validation
                • ✔️Important Interview Questions
                • ............................................................
                • 📍 2 STABILITY STUDY MMASTERY
                • ✔️Basic terms in stability study
                • ✔️Stability Storage Conditions
                • ✔️Selection of batches & batch size
                • ✔️Bracketing & Matrixing
                • ✔️Evaluation of shelf life/retest date
                • ✔️Preparation of annual stability plan
                • ✔️Charging of stability sample
                • ✔️Withdrawal of stability samples
                • ✔️Testing of stability samples
                • ✔️Significant change
                • ✔️Photostability Study
                • ✔️MKT
                • ✔️Freeze-Thaw Study
                • ✔️Excursions of Stability Storage Conditions
                • ✔️Preparation of stability protocol
                • ✔️Preparation of stability schedule
                • ✔️Preparation of stability summary report
                • ✔️Preparation of stability sample withdrawal schedule
                • ✔️IQ of stability chamber
                • ✔️OQ of stability chamber
                • ✔️PQ of stability chamber
                • ............................................................
                • 📍 3 QMS MASTERY
                • ✔️Deviation
                • ✔️Change Control
                • ✔️OOS
                • ✔️OOT
                • ✔️OOE
                • ✔️CAPA
                • ✔️Investigation Tools
                • ✔️FMEA
                • ✔️Fishbone Diagram
                • ✔️5 Whys
                • ✔️QMS examples
                • ✔️Recordings of Live Workshop
                • ............................................................
                • 📍 4 EXTRACTABLES & LEACHABLES
                • ✔️What is the Objective of E&L
                • ✔️What is the source of E&L
                • ✔️Who Needs E&L
                • ✔️How to use Risk-based approach for safety assessment
                • ✔️What are Thresholds for E&L
                • ✔️How to design E&L Study
                • ✔️Extraction techniques
                • ✔️Plastic Immediate Packaging Material
                • ............................................................
                • 📍 5 STATISTICS IN ANALYTICAL CHEMISTRY
                • ✔️Types of Errors
                • ✔️Population Vs. Sample
                • ✔️Common Terms in Statistics
                • Normal distribution
                • ✔️Confidence Limit & Confidence Interval
                • ✔️Central Limit Theorem
                • ✔️Law of Large Numbers
                • ✔️Z-Score
                • ✔️Significance Test
                • ✔️t-Test
                • ✔️F-Test
                • ✔️How to Decide Outlier Results
                • ✔️Residual plots
                • ✔️Grubb’s test
                • ✔️Dixon’s test
                • ............................................................
                • 📍 6 IMPURITY MANAGEMENT BLUEPRINT
                • ✔️Define Impurity Conc in % and ppm wrt Sample
                • ✔️Limit for known, unknown, total impurity
                • ✔️Limit for residual solvents
                • ✔️Release & Stability specification for Impurity
                • ✔️Management of Working & Reference Standard
                • ✔️Impurity limit based on Innovator, Metabolites
                • ✔️Recordings of Live Workshop

              • 4 AMD+AQbD+AMV (6 COURSES)

                1,999₹
                🔥 6 Courses Worth ₹27,985 for ₹1,999 . 📍 1. ANALYTICAL METHOD VAL . 📍 2. ANALYTICAL QbD . 📍 3. HPLC METHOD DEV . 📍 4. GC METHOD DEV . 📍 5. DISSOLUTION METHOD DEV . 📍 6. UV & FTIR METHOD DEV
                 
                • COURSE DETAILS:
                • 📍 1. ANALYTICAL METHOD VALIDATION:
                • ✔Protocol Review Tips
                • ✔Accuracy Vs. Trueness Vs. Bias Vs. Recovery
                • ✔How to Define RSD for Precision
                • ✔Specificity Vs. Selectivity
                • ✔S/N: History and Calculation
                • ✔Challenges During HPLC Method Validation
                • ✔Definition, Use & Calculation of Residual Sum of Squares
                • ✔Accuracy: Dose Proportionate Formulation Vs. Pseudo Dose Pr
                • ✔Working Principles: UV & PDA Fundamentals of each Parameter
                • ✔Peak Purity: Fundamentals, Assessment & Critical Parameters
                • ✔Purity Angle & Purity Threshold
                • ✔Forced Degradation: Need and Design
                • ✔Validation, Revalidation, Co-Validation, and Cross-Validati
                • ✔Cosolvent Selection During Hydrolytic Degradation
                • ✔Reportable Range as per Q2(R2)
                • ✔Sources & Effects of Interference Due to Sample Matrix
                • ✔ICH Vs ANVISA
                • ✔ANVISA: Linearity
                • ✔ANVISA: Forced Degradation
                • ✔ANVISA: Metal Ion Oxidation
                • ............................................................
                • 📍. 2. ANALYTICAL QbD
                • ✔️What is QbD, AQbD, History of QbD
                • ✔️AQbD Common Terms
                • ✔️AQbD Strategic Principles
                • ✔️ICH Q14
                • ✔️Knowledge Space
                • ✔️Design Space
                • ✔️Control Space
                • ✔️Method Development by DoE
                • ............................................................
                • 📍 3. HPLC METHOD DEVELOPMENT
                • ✔Working Principles in Various LC Techniques
                • ✔Selection of an HPLC Column Based in Interaction
                • ✔Selection of HPLC Column Dimension
                • ✔Selection of Pore Size and Ligand for Proteins & Peptides
                • ✔Selection of Mobile Phase Solvent
                • ✔Selection of Mobile Phase Buffer
                • ✔Selection of Mobile Phase pH
                • ✔Role of pH & pKa
                • ✔Determination of pKa by UV Spectroscopy
                • ✔Determination of pKa by UV Potentiometry
                • ✔Case Study: Retention Time
                • ✔Mobile Preparation and Issues
                • ✔Impact of Water Quality on HPLC Analysis
                • ✔Sample Cooler temperature
                • ✔Related Substances Method Development by HPLC
                • ✔Challenges in Relates Substances Method Development
                • ✔Gradient Elution
                • ✔Causes of Peak Splitting & Way to Fix it
                • ✔Why Your LC Column Die
                • ✔Role of Poor Solubility in Method Development
                • ✔How to Remove Carryover
                • ✔Like-Attracts-Like
                • ✔Root Cause Behind Negative Peaks
                • ✔Peak Tailing Reasons & Way Outs
                • ✔Key Differences in the Use of Methanol & Acetonitrile
                • ✔Effect of Diluent on Peak Shape
                • ✔Baseline Noise Reasons & Way outs
                • ✔Retention of Acidic & Basic Compounds in RPLC & Ion Exchang
                • ✔Simple Hacks to Get Smooth Baseline During Gradient Run
                • ✔Chiral Separation: principles
                • ✔Chiral Separation: Protein Based Columns
                • ✔Mobile Phase Handling Precautions
                • ✔Effect of Triethylamine in Mobile Phase
                • ✔Silanol Effect
                • ✔Live Session Recording: 17th Jul 2022
                • ✔Live Session Recording: QbD & AQbD
                • ✔Live Session Recording: 27th Feb 2022
                • ............................................................
                • 📍 4. GC METHOD DEVELOPMENT:
                • ✔Retention Mechanism in GC
                • ✔Stationary Phases in GC
                • ✔Column Selection Based on Nature of Compound
                • ✔Column Selection: Case Studies
                • ✔Column Dimension Vs. Performance
                • ✔Injection Techniques
                • ✔Liquid Vs. Head Space
                • ✔Role of Temperature & Its Selection
                • ✔Role of Carrier Gases & Its Selection
                • ✔Role of Diluent & its Selection
                • ✔Purification of Gases
                • ✔Sample Preparation
                • ✔GC Response Hacks
                • ✔Back-Flash
                • ✔Salting-Out & Its Applications
                • ✔Zero Air
                • ✔Best Carrier Gas for GC
                • ✔Solvent Effect & Peak Tailing
                • ✔Live Session Recording: 13 Mar
                • ............................................................
                • 📍 5. DISSOLUTION METHOD DEVELOPMENT
                • ✔Dissolution: Definition, Guidelines
                • ✔Rotating Apparatuses History & Adaptation by USP
                • ✔Discriminatory Dissolution Method
                • ✔Biorelevant Dissolution Method
                • ✔QC Release Dissolution method
                • ✔Sink Condition & Its Application
                • ✔Intrinsic Dissolution
                • ✔Role of Amorphism in Intrinsic Dissolution
                • ✔Role of Polymorphism in Intrinsic Dissolution
                • ✔Role of Solvates & Hydrates in Intrinsic Dissolution
                • ✔Salt Formation & Intrinsic Dissolution
                • ✔Extrinsic Factors & Their Influence on Dissolution
                • ✔Biorelevant Dissolution Method Development
                • ✔Role of pH and pKa in Solubility and Absorption across GIT
                • ✔Dissolution Method Development (selection of Apparatus, Med
                • ✔BCS
                • ✔Use of Surfactant
                • ✔F2 Calculation
                • ✔Cross Linking
                • ✔Drug’s pKa and its Absorption
                • ✔Selection of Sinkers
                • ✔Selection of Medium for BCS-I Product
                • ............................................................
                • 📍 6. SPECTROSCOPY (UV & FTIR) METHOD DEVELOPMENT
                • ✔Working principles of UV
                • ✔Working principles of FTIR
                • ✔Method development by UV
                • ✔Method development by FTIR

              • INCREDIBLE PHARMA CAREER

                999₹
                How to get a job in Pharma industry within 30-90 days
                 
                • Job Search Strategy
                • Job Search Planner
                • Create World Class Resume
                • Create Incredible LinkedIn profile
                • Prepare For Job Interviews
                • Interview Checklist, Do's and Don'ts
                • Incredible Salary Negotiation
                • Attract Opportunities Like a Magnet
                • Interview Question Model
                • Deep Self Knowledge
                • Job Communication Toolbox
                • Incredible Interview Questions
                • Recruiter Outreach Strategy
                • Resume Architecture

              • CAREER ACCELERATOR PROGRAM PHARMA MFG

                4,999₹
                Perfect for freshers to experienced to achieve exponential career growth in pharma manufacturing
                 
                • 📍 MODULE-1:
                • LECTURE-1: Overview of Indian Pharmaceutical Market
                • LECTURE-2: Overview of Global Pharmaceutical Market
                • LECTURE-3: Pharmaceutical Legislations in India
                • LECTURE-4: Pharmaceutical Legislations in the USA
                • LECTURE-5: Soft Skills Required in the Pharmaceutical Indust
                • LECTURE-6: Good Industry Practices in the Pharmaceutical Ind
                • LECTURE-7: Career Options in the Pharmaceutical Industry
                • LECTURE-8: Different Departments/Functions in the Pharma
                • LECTURE-9: Skills, Qualifications to get a Job in Pharma MFG
                • ............................................................
                • 📍 MODULE-2:
                • LECTURE-10: GMP Facility Design
                • LECTURE-11: HVAC and its Role in Pharma Manufacturing
                • LECTURE-12: HVAC System for Oral Solid Dosage Manufacturing
                • LECTURE-13: HVAC System for Sterile Manufacturing
                • LECTURE-14: HEPA Filters
                • LECTURE-15: Monitoring of Clean room and Filter validation
                • LECTURE-16: Water Purification System in the Pharma Industry
                • LECTURE-17: Equipment Qualification
                • LECTURE-18: Equipment Design Qualification
                • LECTURE-19: Equipment Installation Qualification
                • LECTURE-20: Equipment Operational Qualification
                • LECTURE-21: Equipment Performance Qualification
                • LECTURE-22: Equipment Preventive Maintenance
                • LECTURE-23: Equipment Calibration
                • ............................................................
                • 📍 MODULE-3:
                • LECTURE-24: Common GMP terms Part 1
                • LECTURE-25: Common GMP terms Part 2
                • LECTURE-26: Common GMP terms Part 3
                • LECTURE-27: Common GMP terms Part 4
                • LECTURE-28: Drugs and Cosmetics Act 1940
                • LECTURE-29: GMP (Schedule M) Part 1
                • LECTURE-30: GMP (Schedule M) Part 2
                • LECTURE-31: GMP (Schedule M) Part 3
                • LECTURE-32: CFR
                • LECTURE-33: USFDA GMP Part 1
                • LECTURE-34: USFDA GMP part 2
                • LECTURE-35: USFDA GMP Part 3
                • LECTURE-36: USFDA GMP Part 4
                • LECTURE-37: WHO GMP Part 1
                • LECTURE-38: WHO GMP Part 2
                • LECTURE-39: WHO GMP Part 3
                • LECTURE-40: WHO GMP Part 4
                • LECTURE-41: WHO GMP Part 5
                • LECTURE-42: WHO GMP Part 6
                • LECTURE-43: WHO GMP Part 7
                • ............................................................
                • 📍 MODULE-4:
                • LECTURE-44: Personnel Training for GMP
                • LECTURE-45: Personnel Hygiene for OSD & Sterile Mfg.
                • LECTURE-46: Sanitization and Hygiene
                • LECTURE-47: Self-Inspection
                • LECTURE-48: Regulatory Audit
                • LECTURE-49: Complaints and Recalls
                • ............................................................
                • 📍 MODULE-5:
                • LECTURE-50: Deviation
                • LECTURE-51: Change Control
                • LECTURE-52: Investigation
                • LECTURE-53: 5Whys Investigation tool
                • LECTURE-54: Fishbone Investigation tool
                • LECTURE-55: FMEA
                • LECTURE-56: CAPA
                • LECTURE-57: OOS
                • LECTURE-58: QRM
                • ............................................................
                • 📍 MODULE-6:
                • LECTURE-59: Vendor Qualification
                • LECTURE-60: Receipt, Sampling, and Dispensing
                • LECTURE-61: Finished Product Warehouse
                • LECTURE-62: Manufacturing and Packaging of Tablets
                • LECTURE-63: Manufacturing and Packaging of Capsules
                • LECTURE-64: Manufacturing and Packaging of Oral Liquids
                • LECTURE-65: Manufacturing and Packaging of Injectables
                • LECTURE-66: Batch Manufacturing Record
                • LECTURE-67: Batch Packaging Record
                • LECTURE-68: Labelling of Pharmaceutical Product
                • LECTURE-69: In-process Test: Tab., Caps, Oral liq., Inj.
                • LECTURE-70: Unit Operations in API
                • LECTURE-71: Effluent Treatment Plant

              • CAREER ACCELERATOR PROGRAM PHARMA QC

                4,999₹
                Perfect for beginners and experienced one to start and grow a career in the Pharmaceutical quality control
                 
                • 📍 MODULE-1:
                • LECTURE-1: Overview of Indian Pharmaceutical Market
                • LECTURE-2: Overview of Global Pharmaceutical Market
                • LECTURE-3: Pharmaceutical Legislations in India
                • LECTURE-4: Pharmaceutical Legislations in the USA
                • LECTURE-5: Soft Skills Required in the Pharma Industry
                • LECTURE-6: Good Industry Practices in the Pharma Industry
                • LECTURE-7: Career Options in the Pharmaceutical Industry
                • LECTURE-8: Diff. Dept. in the Pharma Industry & their Roles
                • LECTURE-9: Skills & Qualifications to get a Job in QC
                • ............................................................
                • 📍 MODULE-2:
                • LECTURE-10: Impurity in New Drug Substances as per ICH
                • LECTURE-11: Impurity in New Drug Products as per ICH
                • LECTURE-12: Residual Solvents in Drug products as per ICH
                • LECTURE-13: Genotoxic Impurities as per ICH
                • LECTURE-14: Nitrosamine
                • LECTURE-15: Classification of res sol and elemental imp
                • ............................................................
                • 📍 MODULE-3:
                • LECTURE-16: Analyst Qualification
                • LECTURE-17: Operation and Use of DT Apparatus
                • LECTURE-18: Operation and Use of Friability Apparatus
                • LECTURE-19: Operation and Use of pH Meter
                • LECTURE-20: Operation and Use of Analytical Balance
                • LECTURE-21: Operation and Use of UV Spectrophotometer
                • LECTURE-22: Operation and Use of HPLC
                • LECTURE-23: Operation and Use of GC
                • LECTURE-24: Operation and Use of Dissolution Apparatus
                • LECTURE-25: Operation and Use of FTIR
                • LECTURE-26: Operation and Use of Sonicator
                • ............................................................
                • 📍 MODULE-4:
                • LECTURE-27: Instrument Calibration- Analytical balance
                • LECTURE-28: Instrument Calibration- pH Meter
                • LECTURE-29: Instrument Calibration- HPLC
                • LECTURE-30: Instrument Calibration- GC
                • LECTURE-31: Instrument Calibration- Dissolution Apparatus
                • LECTURE-32: Cal. template:Balance, pH, HPLC, GC, Dissolution
                • LECTURE-33: Instrument IQ OQ PQ
                • LECTURE-34: Instrument Qualification- Analytical balance
                • LECTURE-35: Instrument Qualification- pH Meter
                • LECTURE-36: Instrument Qualification- HPLC
                • LECTURE-37: Instrument Qualification- GC
                • LECTURE-38: Instrument Qualification- Dissolution Apparatus
                • ............................................................
                • 📍 MODULE-5:
                • LECTURE-39: Reporting and Rounding of Result Part 1
                • LECTURE-40: Reporting and Rounding of Result Part 2
                • LECTURE-41: Reporting and Rounding of Result Part 3
                • LECTURE-42: Basic Calculation Functions Part 1
                • LECTURE-43: Basic Calculation Functions Part 2
                • ............................................................
                • 📍 MODULE-6:
                • LECTURE-44 Deviation
                • LECTURE-45: Change Control
                • LECTURE-46: Investigation
                • LECTURE-47: 5Whys Investigation tool
                • LECTURE-48: Fishbone Investigation tool
                • LECTURE-49: FMEA
                • LECTURE-50: CAPA
                • LECTURE-51: OOS
                • LECTURE-52: QRM
                • LECTURE-53: DATA INTEGRITY
                • ............................................................
                • 📍 MODULE-7:
                • LECTURE-54: Analytical Method Validation
                • LECTURE-55: Cleaning Validation
                • LECTURE-56: Glassware Cleaning Validation
                • LECTURE-57: Method Transfer
                • LECTURE-58: Method Verification
                • LECTURE-59: Spec. for API, Tablets, Oral Liquids, Injectable
                • LECTURE-60: Stability Study

              • CAREER ACCELERATOR PROGRAM PHARMA QA

                4,999₹
                Perfect for beginners and experienced to start and grow a career in the Pharmaceutical quality assurance
                 
                • 📍 MODULE-1:
                • LECTURE-1: Overview of Indian Pharmaceutical Market
                • LECTURE-2: Overview of Global Pharmaceutical Market
                • LECTURE-3: Pharmaceutical Legislations in India
                • LECTURE-4: Pharmaceutical Legislations in the USA
                • LECTURE-5: Soft Skills Required in the Pharma Industry
                • LECTURE-6: Good Industry Practices in the Pharma Industry
                • LECTURE-7: Career Options in the Pharmaceutical Industry
                • LECTURE-8: Diff. Dept in the Pharma Industry & Roles
                • LECTURE-9: Skills & Qualifications to get a Job in QA
                • ............................................................
                • 📍 MODULE-2:
                • LECTURE-10: GMP Facility Design
                • LECTURE-11: HVAC and its Role in Pharma Manufacturing
                • LECTURE-12: HVAC System for Oral Solid Dosage Manufacturing
                • LECTURE-13: HVAC System for Sterile Manufacturing
                • LECTURE-14: HEPA Filters
                • LECTURE-15: Monitoring of Clean room and Filter validation
                • LECTURE-16: Water Purification System in the Pharma Industry
                • LECTURE-17: Equipment Qualification
                • LECTURE-18: Equipment Design Qualification
                • LECTURE-19: Equipment Installation Qualification
                • LECTURE-20: Equipment Operational Qualification
                • LECTURE-21: Equipment Performance Qualification
                • LECTURE-22: Equipment Preventive Maintenance
                • LECTURE-23: Equipment Calibration
                • ............................................................
                • 📍 MODULE-3:
                • LECTURE-24: Site Master File (SMF)
                • LECTURE-25: Site master File example
                • LECTURE-26: Quality Manual with example
                • LECTURE-27: Validation Master Plan (VMP) with its example
                • LECTURE-28: Product Quality Review (PQR)
                • LECTURE-29: Vendor Qualification
                • LECTURE-30: Area Qualification
                • LECTURE-31: Document Control
                • LECTURE-32: Types of Documents
                • LECTURE-33: SOP of SOP
                • LECTURE-34: Internal Audit
                • LECTURE-35: Line clearance
                • LECTURE-36: Trend analysis
                • LECTURE-37: Review of BMR
                • LECTURE-38: Market Complaints and Product Recalls
                • LECTURE-39: Personnel Training for GMP
                • LECTURE-40: Regulatory Audit
                • ............................................................
                • 📍 MODULE-4:
                • LECTURE-41: Impurity in New Drug Substances as per ICH
                • LECTURE-42: Impurity in New Drug Products as per ICH
                • LECTURE-43: Residual Solvents in Drug products as per ICH
                • LECTURE-44: Genotoxic Impurities as per ICH
                • LECTURE-45: Nitrosamine
                • LECTURE-46: Classification of res sol and elemental imp
                • ............................................................
                • 📍 MODULE-5:
                • LECTURE-47: Deviation
                • LECTURE-48: Change Control
                • LECTURE-49: Investigation
                • LECTURE-50: 5Whys Investigation tool
                • LECTURE-51: Fishbone Investigation tool
                • LECTURE-52: FMEA
                • LECTURE-53: CAPA
                • LECTURE-54: OOS
                • LECTURE-55: QRM
                • LECTURE-56: DATA INTEGRITY
                • ............................................................
                • 📍 MODULE-6:
                • LECTURE-57: Analytical Method Validation
                • LECTURE-58: Cleaning Validation
                • LECTURE-59: Method Transfer
                • LECTURE-60: Method Verification
                • LECTURE-61: Spec. for API, Tablets, Oral Liquids, Injectable
                • LECTURE-62: Stability Study

              • CAREER ACCELERATOR PROGRAM PHARMA AR&D

                4,999₹
                Perfect for freshers and experienced professionals to achieve exponential career growth in pharma AR&D
                 
                • 📍 *MODULE-1:*
                • LECTURE-1: Overview of Indian Pharmaceutical Market
                • LECTURE-2: Overview of Global Pharmaceutical Market
                • LECTURE-3: Pharmaceutical Legislations in India
                • LECTURE-4: Pharmaceutical Legislations in the USA
                • LECTURE-5: Soft Skills Required in the Pharma Industry
                • LECTURE-6: Good Industry Practices in the Pharma Industry
                • LECTURE-7: Career Options in the Pharmaceutical Industry
                • LECTURE-8: Diff. Depts in the Pharma & their Roles
                • LECTURE-9: Skills & Qualifications to get a Job in AR&D
                • ............................................................
                • 📍 MODULE-2:
                • LECTURE-10: Impurity in New Drug Substances as per ICH
                • LECTURE-11: Impurity in New Drug Products as per ICH
                • LECTURE-12: Residual Solvents in Drug products as per ICH
                • LECTURE-13: Genotoxic Impurities as per ICH
                • LECTURE-14: Nitrosamine
                • LECTURE-15: Classification of res sol and elemental impurity
                • ............................................................
                • 📍 MODULE 3:
                • LECTURE-16: Analyst Qualification
                • LECTURE-17: Operation and Use of DT Test Apparatus
                • LECTURE-18: Operation and Use of Friability Apparatus
                • LECTURE-19: Operation and Use of pH Meter
                • LECTURE-20: Operation and Use of Analytical Balance
                • LECTURE-21: Operation and Use of UV Spectrophotometer
                • LECTURE-22: Operation and Use of HPLC
                • LECTURE-23: Operation and Use of GC
                • LECTURE-24: Operation and Use of Dissolution Apparatus
                • LECTURE-25: Operation and Use of FTIR
                • LECTURE-26: Operation and Use of Sonicator
                • ............................................................
                • 📍 MODULE 4:
                • LECTURE-27: Instrument Calibration- Analytical balance
                • LECTURE-28: Instrument Calibration- pH Meter
                • LECTURE-29: Instrument Calibration- HPLC
                • LECTURE-30: Instrument Calibration- GC
                • LECTURE-31: Instrument Calibration- Dissolution Apparatus
                • LECTURE-32: Cal. template:Balance, pH meter, HPLC, GC, Disso
                • LECTURE-33: Instrument IQ OQ PQ
                • LECTURE-34: Instrument Qualification- Analytical balance
                • LECTURE-35: Instrument Qualification- pH Meter
                • LECTURE-36: Instrument Qualification- HPLC
                • LECTURE-37: Instrument Qualification- GC
                • LECTURE-38: Instrument Qualification- Dissolution Apparatus
                • ............................................................
                • 📍 MODULE 5:
                • LECTURE-38: Reporting and Rounding of Result Part 1
                • LECTURE-39: Reporting and Rounding of Result Part 2
                • LECTURE-40: Reporting and Rounding of Result Part 3
                • LECTURE-41: Basic Calculation Functions Part 1
                • LECTURE-42: Basic Calculation Functions Part 2
                • ............................................................
                • 📍 MODULE 6:
                • LECTURE-43 Deviation
                • LECTURE-44: Change Control
                • LECTURE-45: Investigation
                • LECTURE-46: 5Whys Investigation tool
                • LECTURE-47: Fishbone Investigation tool
                • LECTURE-48: FMEA
                • LECTURE-49: CAPA
                • LECTURE-50: OOS
                • LECTURE-51: QRM
                • LECTURE-52: DATA INTEGRITY
                • ............................................................
                • 📍 MODULE 7:
                • LECTURE-53: Analytical Method Validation
                • LECTURE-54: Cleaning Validation
                • LECTURE-55: Method Transfer
                • LECTURE-56: Method Verification
                • ............................................................
                • 📍 MODULE 8:
                • LECTURE-57: UV Spectroscopic and FTIR Method Development
                • LECTURE-58: HPLC Method Development
                • LECTURE-59: GC Method Development
                • LECTURE-60: Dissolution Method Development
                • LECTURE-61: Stability Study
                • LECTURE-62: IVIVC
                • LECTURE-63: Drug Substance Discovery and Development
                • LECTURE-64: New Drug Clinical Trials
                • LECTURE-65: Excipient Compatibility

              • UK RUSSIA USA CHINA DRA CRASH COURSE

                1,999₹
                 

                • INTERNATIONAL DRA

                  9,999₹
                   

                  • EU, JAPAN, GCC & MIDDLE EAST DRA

                    1,999₹
                    🔥 Grab 4 Courses Worth ₹23,996 for Just ₹1,999🔥 1. EU Drug Regulatory Affairs 2. JAPAN Drug Regulatory Affairs 3. GCC Drug Regulatory Affairs 4. MIDDLE EAST Drug Regulatory Affairs
                     
                    • 📍 1. EU DRUG REGULATORY AFFAIRS
                    • Introduction to EU Regulation
                    • European Countries & National Regulatory Bodies
                    • EU Drug Discovery to Commercialization
                    • EU Drug Regulatory Overview
                    • EMA & Authorization Process
                    • EU MA Application Types & Planning
                    • EU MA Procedures
                    • EU MA Strategic Planning
                    • Validity of the EU Marketing Authorization
                    • Data Exclusivity & Market Protection
                    • EU Regulation of Orphan Drug
                    • EU Conditional Marketing Authorisation
                    • Summary of Product Characteristics (SmPC)
                    • Compassionate Use Program in EU
                    • Investigational Medicinal Product Dossier
                    • Investigator’s Brochure
                    • Pediatric Use Marketing Authorisation
                    • EU Variation Management
                    • EU Prime Designation
                    • EU Accelerated Assessment
                    • EU Adaptive Pathway
                    • European Public Assessment Report
                    • SPOR Master Data
                    • PDE Value
                    • The Sunset Clause
                    • ************************************************************
                    • 📍 2. JAPAN DRUG REGULATORY AFFAIRS
                    • Introduction to Japan DRA
                    • Japan Drug Discovery to Commercialization
                    • Drug Approval System & Clinical Trials
                    • NDA Requirement & process
                    • Generic Drug Application Review & Approval Process
                    • MA Process in Japan
                    • API Registration in Japan
                    • Market Exclusivity
                    • Priority Review
                    • Orphan Drug Registration
                    • Drug Master File System
                    • Approval Review for Drug Product
                    • SAKIGAKE
                    • ************************************************************
                    • 📍 3. GCC DRUG REGULATORY AFFAIRS
                    • MENA & Middle East Geographical Location
                    • National Medicine Regulatory Agencies in MENA
                    • GCC Registration Procedure
                    • Drug Registration & Regulation in Saudi Arabia
                    • Product Classification by SFDA
                    • MA Application Strategic Pathways
                    • Variation of Marketing Authorisation
                    • Renewal of Marketing Authorisation
                    • Key Note Points Regarding MAA With SFDA
                    • Drug Registration & Regulation in UAE
                    • ************************************************************
                    • 📍 4. MIDDLE EAST DRUG REGULATORY AFFAIRS
                    • Drug Registration & Regulation in Iran
                    • Drug Registration & Regulation in Saudi Arabia
                    • Drug Registration & Regulation in Jordan
                    • Drug Registration & Regulation in Iraq

                  • METHOD VALIDATION PACKAGE

                    1,999₹
                     

                    • US, UK, EU, CTD&DMF

                      1,999₹
                       
                      bottom of page