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EU, UK, JAPAN, GCC, MIDDLE EST-5 COURSES
1,999₹🔥 Grab 5 Courses Worth ₹27,995 for Just ₹1,999 🔥 📍 1. EU DRA 📍 2. UK-MHRA DRA 📍 3. JAPAN DRA 📍 4. GCC DRA 📍 5. MIDDLE EAST DRA- 📍 1. EU DRUG REGULATORY AFFAIRS
- Introduction to EU Regulation
- European Countries & National Regulatory Bodies
- European Countries & National Regulatory Bodies
- EU Drug Regulatory Overview
- EMA & Authorization Process
- EU MA Application Types & Planning
- EU MA Procedures
- 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. UK-MHRA DRUG REGULATORY AFFAIRS
- UK MHRA Landscape Post BREXIT
- Establishment of MHRA
- Fast Tract Marketing Authorisation
- Full Application
- Generic, Hybrid, Biosimilar Application
- Fixed Combination Application
- Informed Consent Application
- Submission Format (eCTD)
- Active Substance Master Files (ASMFs)
- MHRA’s DMRC
- MA Expiry
- 📍 3. 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
- ************************************************************
- 📍 4. 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
- ************************************************************
- 📍 5. 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
PHARMA LEADERSHIP LAUNCHPAD
7,999₹US, UK, CHINA, RUSSIA, LATAM
1,999₹CV, STABILITY, QMS, E&L, STATISTICS
1,999₹🔥Grab 5 Courses Worth ₹21,995 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
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
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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
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- Interview Checklist, Do's and Don'ts
- Incredible Salary Negotiation
- Attract Opportunities Like a Magnet
- Interview Question Model
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- Incredible Interview Questions
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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
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- 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
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- ✔️ Overview of Common Technical Document (CTD)
- ✔️ CMC Dossier Preparation and Regulatory Compliance
- ✔️ eCTD Training
- ✔️ Practical Training on Dossier Preparation
- ✔️ Stability Testing for Pharmaceuticals
- ✔️ DMF Preparation and Submission
- ✔️ Practical Training on DMF Preparation
- ✔️ Site Master File (SMF)
- ✔️ DMF Completeness Assessment
- ✔️ DMF Fees
- ✔️ DMF in Global Perspective
- ✔️ Effective Management of Dossiers
- ✔️ Common Mistakes in Dossier Preparation
- ✔️ Certificate of Analysis
- ✔️ ANDA Submission Filing
- ✔️ Importance of PAS in ANDA Filing
- ✔️ Case-Based Learning: 505(b)(2) vs. ANDA Suitability Petit
- ✔️ Case-Based Learning: NCE vs. 505(b)(2) Application
- ✔️ Case-Based Learning: FTF vs. 505(b)(2)
- ✔️ Case-Based Learning: 505(b)(2) Filing
- ✔️ 505(b)(2): Mitigating 30-Month Stay in ANDA Filings
- ✔️ Climate Zone Considerations
- ✔️ Country-Specific Stability Zones
- ✔️ Case-Based Discussion: Stability Study
- ✔️ Stability Data for Zone IV Countries
- ✔️ Accelerated and Intermediate Testing Conditions
- ✔️ Long-Term Testing Conditions
- ✔️ Testing Frequency
- ✔️ Bracketing and Matrixing
- ✔️ PK/PD in Drug Discovery
- ✔️ Bioequivalence Study and Designs
- ✔️ Biopharmaceutics Classification System (BCS)
- ✔️ Bioequivalence and Stability Study Requirements
- ✔️ Bioequivalence and Dissolution Data Submission
- ✔️ Generic Drug Approval and Additives Labeling
- ✔️ Variation Management and Classification
- ✔️ Setting Dissolution Specifications
- ✔️ Regulatory Requirements for Biosimilars
- ✔️ CMC Writing Checklist
- ✔️Comparison of DMF Requirements of Various Countries
- ✔️Comparison of ICH, US & EU CTD Requirements
- ............................................................
- 📍 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. LATAM DRUG REGULATORY AFFAIRS
- ✔Introduction to LATAM
- ✔Drug Registration and Regulation in *Brazil*
- ✔Drug Registration and Regulation in *Chile*
- ✔Drug Registration and Regulation in *Argentina*
- ✔Drug Registration and Regulation in *Mexico*
- ✔Drug Registration and Regulation in *Colombia*
- ✔Drug Registration and Regulation in *Bolivia*
- ✔Drug Registration and Regulation in *El Salvador*
- ✔Drug Registration and Regulation in *Central America*
- ............................................................
- 📍 4. 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
- ............................................................
- 📍 5. 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
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