When & How?
- Schedule: Every Monday to Saturday, from 7:30 PM to 9:30 PM
- Each Session duration: 60 to 90 minutes
- Sessions (total):
- Most Popular course: 7 to 8
- Advanced Course: 11 to 12
- Mode of Delivery: Live sessions conducted via Google Meet, featuring expert-led instruction and professional presentations.
Note:
- Each course in the Most Popular course categories will be completed over 7 to 8 sessions, with each session lasting between 60 to 90 minutes.
- Each course in the Advanced Course category will span 11 to 12 sessions, with each session lasting between 60 to 90 minutes.
Training Fees:
- Most Popular course: ₹8100 or $100
- Advance Course: ₹16200 or $200
Who Should Attend?
- Industry Professionals: Individuals seeking to upskill and stay current with the latest pharmaceutical practices.
- Career Changers: Professionals looking to transition into the pharmaceutical sector.
- Job Seekers & Fresh Pharmacy Graduates/Post Graduates/Post Doctorates: Recent Fresh Pharmacy Graduates/Post Graduates/Post Doctorates and aspiring candidates aiming to launch a career in the pharmaceutical industry.
- Team Leaders & Managers: Supervisors responsible for developing team capabilities and enhancing operational performance.
- Knowledge Enthusiasts: Anyone with a keen interest in gaining in-depth insights into pharmaceutical processes and industry standards.
- Academicians: Lecturers and professors looking to enhance their industry-relevant knowledge to better guide students.
- Students: Pharmacy, chemistry, and life science students aiming to strengthen their academic
PharmaGuru Course Syllabus
Below are the syllabus highlights for our pharmaceutical training programs. Detailed syllabi for additional courses are available upon request.
1. Method Validation Online Training Course
Key Learnings: Method Validation Online Training Course
Gain comprehensive, practical knowledge to confidently design, execute, and document analytical method validation in compliance with regulatory expectations. This course covers:
Foundational Concepts
- In-depth understanding of method validation and verification in pharmaceutical analysis.
- Importance and regulatory need for Analytical Method Validation (AMV).
- Classification of analytical methods and their corresponding validation requirements.
- Overview of international guidelines (ICH, USP, etc.) relevant to method validation.
Validation Strategy and Planning
- Designing an effective validation strategy tailored to method classification.
- Essential components and pre-validation activities.
- Selection and justification of validation parameters.
- Structuring and drafting a method validation protocol.
Execution of Validation Studies
- Specificity: How to evaluate and document method specificity.
- Detection Limit (DL) and Quantitation Limit (QL): Methods for determination.
- Precision studies:
- System repeatability
- Method repeatability
- Intermediate precision
- Method reproducibility
- Linearity and range: How to conduct and interpret results.
- Relative Response Factor (RRF): Calculation and significance.
- Accuracy and recovery: Experimental design and calculations.
- Solution stability: How to evaluate and document stability over time.
- Robustness: Identifying and assessing method robustness.
Documentation and Reporting
- Preparation of a comprehensive validation report.
- Report approval workflow and documentation standards.
- Validation of compendial/pharmacopoeial methods: Best practices and considerations.
Advanced Topics and Case Studies
- Cross-validation and re-validation: When and how to perform.
- Real-world case studies for practical understanding.
- Frequently Asked Questions (FAQs) and interview preparation.
Bonus Topics
- Troubleshooting validation parameter failures.
- Risk assessment and mitigation in method validation.
- Common pitfalls and how to avoid them during validation.
- Strategies to minimize regulatory deficiencies and avoid queries.
2. Online HPLC Method Development Training Course
Overview: Learn the foundational principles of High-Performance Liquid Chromatography (HPLC) Method Development and apply them to pharmaceutical testing.
Key Topics:
- Analytical method development?
- Why are chromatographic techniques needed?
- A Bird’s Eye View on Commonly Used Chromatographic Techniques
- HPLC and its components
- How to read a chromatogram?
- RT, RRT, area response and peak height
- Types of chromatography
- HPLC operating parameters
- Basic separation mechanism
- Detectors
- Chromatographic terms and System suitability test parameters (K, N, R, T, As, HETP, RSD, DL, QL. As)
- Mobile Phase Chemistry
- Type of Elution mode
- Column chemistry
- A bird’s Eye view on different Analytical tests
- Advantages and disadvantages of HPLC
- Role of NPC, RPC and IP-RPC in HPLC method development
- pH and its role in HPLC method development
- pKa and its role in HPLC method development
- Role of polarity in HPLC method development
- How to equilibrate the column faster?
- Elution mode selection: Isocratic vs Gradient: advantages and disadvantages
- Modes of calculation
- How to prepare solutions of different concentrations (mcg, ppm etc)
- Different components of the HPLC method
- Precautions required during HPLC analysis
- Compounds classification based on polarity
- HPLC Separation Principle
- A Bird’s Eye view on HPLC separation mechanism
- How to predict elution order?
- RFT approach in HPLC method development
- Method development steps
- Sample preparation procedures
- Chromatographic mode selection
- Column selection procedure
- Mobile phase selection procedure
- Selection of buffer (type and concentration)
- Selection of a modifier
- Solvent selection and optimisation
- Detector Selection and role of PDA detector in HPLC method development
- Calculation mode selection
- How to optimise retention time?
- Method Optimisation in gradient and isocratic mode(Temperature, sample concentration, injection volume, flow rate, wavelength and separation)
- Characteristics of a newly developed HPLC method
- HPLC Method verification
- Common HPLC troubleshooting
- How to reduce noise?
- How to deal with overpressure in the column?
- How to deal with column equilibration issue?
- How to deal with SST failure issue?
- How to deal with mobile phase precipitation?
- How to increase the HPLC column life?
- Brief discussion on column care
- Separation of a mixture of nonpolar, polar acidic, polar basic, strongly acidic and strongly basic compounds
- How to develop a cost-effective method
- How to develop HPLC-MS compatible method?
- How to peak integration?
- How to check peak purity?
- Case Studies (7 to 11)
- Exercise
- FAQs and Interview questions
3. GC Method Development Training Course
Overview: Master Gas Chromatography (GC) technique and learn how to develop methods for pharmaceutical applications.
Key Topics:
- Principle of Gas Chromatography
- Components of Gas chromatography and their function
- Types of Gas Chromatography
- Detectors used in GC
- GC column chemistry
- GC column selection
- GC method development steps
- How to choose split and splitless liners?
- How to develop a cost-effective GC system?
- How to decide GC method system suitability?
- Modes of calculation
- Factors affecting GC analysis
- How to prepare a sample and standard solution?
- Test performed by GC
- How to decide system suitability?
- Factors affecting GC separation
- Applications of Gas Chromatography
- Case studies (at least 5)
- Allowable adjustment in the GC method
- How to prepare GC method
- How to verify GCHS method
- Principle of GC-HS
- Components of GCHS
- GCHS analysis procedure
- GC-HS method development steps
- How to decide GCHS diluent?
- Case studies (at least 5)
- How to prepare the GC-HS method
- How to verify GCHS method?
- FAQs and Interview Questions on GC and GCHS
4. Online Chiral Method Development Training Course
Overview: Understand how to develop chiral methods using Quality by Design (QBD) principles, optimizing quality and performance throughout the process.
Key Topics:
Introduction to chiral separation and analysis, QBD principles and their application to chiral methods. Chiral and Achiral molecules, Enantiomers, Diastereomers, Racemate and Meso-form, RS Nomenclature, Importance of Chiral separation, Thalidomide tragedy, analytical techniques for Chiral separation, Chiral Stationary Phases (CSPs) Chemistry, HPLC chiral column selection, GC chiral column selection, Chiral separation method development steps, QBD approach in Chiral method development, Chiral method development of molecule containing 1 or 2 chiral centers, How to optimize Chiral method, Case studies (at least 5 to 7), Advancements in Chiral GC, Can Achiral impurities be separated along with Chiral isomers?, and Common troubleshooting during chiral method development….
Control of Pharmaceutical Impurities Training Course
Overview: Learn how to implement the QBD framework for controlling pharmaceutical impurities, ensuring drug safety and efficacy.
Key Topics:
What is the Impurities Control Strategies? QBD in risk-based control strategies. Impurities classification. Sources and control of Impurities in pharmaceuticals such as Achiral impurities, Chiral impurities, Isomeric impurities, Elemental Impurities, and Degradation Impurities. How, where and at what level should Impurities be controlled? Detail discussion of the formation of Impurities. Genotoxic impurities and their control strategies. Genotoxic chemicals and their chemical properties. Factors affecting Genotoxicity. Purge factor calculation. Impurities classification (Class-1, Class-2, Class-3, Class-4 and Class-5). TTC (threshold of toxicological concern) concept. Structure Alerts (SAs) concept/In silico system for Identification of Genotoxins. Challenges with Insilco predictions. Genotoxicity and Mutagenicity. Nitrosamines in Pharmaceutical and their control strategy. Approaches to Identify and Control the Unknown Impurities. FAQs on Impurities Control Strategies. ​Real-world examples and best practices.
5. Courses As Per Requirement
The training details of the following courses are provided as per the Customer’s requirements: Contact Us
- Step-by-Step Analytical Method Validation
- Step-by-Step Guide to HPLC Method Development
- Step-by-Step Guide to GC Method Development
- Step by Step Chiral Method Development
- QBD approach in Control of Pharmaceutical Impurities
- Step-by-Step Guide to LCMS Method Development
- Step-by-Step Guide to GCMS Method Development
- Validation and Verification of Analytical Method
- Forced Degradation Study and Photo Stability
- RFT Approach in Technology Transfer of Analytical Method
- QBD approach in Pharmaceutical method development
- QBD approach in Control of Pharmaceutical Impurities
- Potency, Purity and Assay in Pharmaceutical Analysis
- Pharma Interview Preparation
- Guide to Effective CAPA Management
- Basic FDA GLP Training
- GMP (Good Manufacturing Practices in Pharmaceuticals
- Avoiding Pharmaceutical Data Integrity Problems
- Handling OOS, OOT and completing the investigation report
- Stability Testing
- Role of RRF in the im Related substances test
- SOP: How to Write and Implement
- IQ, OQ and PQ
- How to handle an FDA Audit?
- How to define pharmaceutical specifications
- Analytical Techniques used in Pharmaceutical Analysis