PharmaGuru Premium Course: Unlock Your Potential

Unlock Your Potential with PharmaGuru Premium Course

PharmaGuru offers premium pharmaceutical courses for beginners and professionals. Choose the right course from the options below to enhance your skills and accelerate your career growth with industry-relevant training:

1. PharmaGuru Most Popular Courses
2. PharmaGuru Advanced Courses

Most Popular Vs Advanced Pharma Courses: Key Differences

The 7 Most In-Demand Pharma Premium Courses | Most Popular and Advanced Categories:

Choose the course that fits your career goals and click “Buy Now” to Enroll today:

1. Ultimate Chiral Separation Training by HPLC & GC: From Basics to Advanced
2. The High-Demand HPLC Method Development Training: Basics to Advanced
3. Mastering Analytical Method Validation: Complete Training from Basics to Advanced
4. QbD-Based Pharmaceutical Impurity Control Training: From Basics to Advanced
5. Mastering Pharmaceutical Stability & Shelf Life Evaluation
6. QbD-Based Analytical Control Preparation Training For Pharma Professionals
7. Step-by-Step GC Method Development Training

1. Ultimate Chiral Separation Training by HPLC & GC: From Basics to Advanced (PharmaGuru Training)

Module 1: Selecting the Right Chiral Separation Technique

• How to choose between Chiral HPLC and Chiral GC based on analyte properties, volatility, polarity, thermal stability, MW, and regulatory needs.
• Decision tree for technique selection with real-world examples.

Module 2: Principles of Chiral Method Development

• Fundamental concepts of enantioselectivity, chiral recognition, and asymmetric interactions.
• Key parameters: selectivity (α), resolution (Rs), efficiency (N), and retention (k’).
• Understanding three-point interaction models in chiral separations.

Module 3: Selecting Mobile Phase for Chiral HPLC

• How to choose normal-phase vs reversed-phase vs polar-organic modes.
• Rules for selecting heptane/alcohol ratios, aqueous buffers, and polar solvents.
• Mobile phase impact on selectivity, resolution, retention, and stability.

Module 4: Selecting Modifiers for Chiral HPLC

• Choosing the right alcohol, acid/base additives, and polar modifiers.
• How modifiers influence interaction mechanisms, peak shapes, and enantioselectivity.
• Troubleshooting issues caused by modifiers.

Module 5: Selecting the Right Chiral Column (CSP) for HPLC

• Overview of polysaccharide, Pirkle-type, cyclodextrin, protein, and macrocyclic antibiotic CSPs.
• How to select CSPs using structure-based screening and interaction mapping.
• How to design a column screening strategy to maximise success.

Module 6: Selecting CSPs for Chiral GC

• Choosing cyclodextrin-based, derivatised, and specialised GC chiral stationary phases.
• Selection based on volatility, functional groups, stability, and temperature limits.
• GC-specific chiral screening strategy.

Module 7: Structured Separation Strategies for Different Types of Chiral Molecules

a) Molecules with One Chiral Centre

• Predicting interactions and choosing the correct CSP and mobile phase.
• Simplified decision map for first-pass screening.

b) Molecules with Two Chiral Centres

• Understanding diastereomeric vs enantiomeric separation challenges.
• Strategy to handle multiple peaks and co-elution.

c) Molecules with Multiple Chiral Centres

• Handling complex stereochemical patterns.
• Advanced column pairing and multi-technique approaches.

Module 8: Reducing Analysis Cost in Chiral HPLC & GC

• Techniques to cut solvent usage, runtime, and column wear.
• How to select cost-efficient columns and mobile phases without sacrificing quality.
• Using common method strategies.

Module 9: Optimization & Finalization of Routine Chiral Methods

• Step-by-step optimisation workflow: screen → refine → optimise → validate.
• Robustness, intermediate precision, and system suitability criteria.
• Converting development methods into validated routine methods.

Module 10: Preparing a Chiral Method Development Report

• How to document:
  • Column screening results
  • Mobile phase rationale
  • Optimization experiments
  • System suitability justification
  • Final method summary
• Regulatory expectations for pharma-quality chiral methods.

Module 11: Case Studies, FAQs & Real-World Problem Solving

• 7+ detailed case studies covering:
  • One-centre and multi-centre chiral molecules
  • HPLC vs GC technique decisions
  • Troubleshooting poor selectivity, co-elution, and long runtime
  • Cost reduction examples
• Interactive FAQs with practical troubleshooting guidance.
• Bonus: Real industry challenges and expert solutions.

2. The High-Demand HPLC Method Development Training: Basics to Advanced (PharmaGuru)

Module 1: Getting Started with HPLC Method Development

• How to initiate HPLC method development for assay, related substances, and impurity profiling.
• Understanding regulatory expectations for method scope and target performance.

Module 2: Principles of HPLC Separation Mechanism

• Fundamentals of chromatographic interactions, retention, selectivity, and resolution.
• Role of partitioning, adsorption, ion-exchange, and size exclusion in separation efficiency.

Module 3: Selecting the Right HPLC Mode

• Choosing between reversed-phase, normal-phase, ion-pair, HILIC, and ion-exchange modes.
• Mode selection based on analyte polarity, pKa, functional groups, solubility, and complexity.

Module 4: Selecting HPLC Columns / Stationary Phases

• How to choose the best C18, C8, phenyl, polar-embedded, HILIC, and specialty phases.
• Column selection workflow using analyte structure and separation goals.
• Column screening strategies to increase first-pass success.

Module 5: Method Development for Simple Molecules (<5 Impurities)

• Designing a fast, efficient, and cost-effective method for low-complexity impurity profiles.
• Approach for early screening, mobile phase optimisation, and resolution mapping.

Module 6: Method Development for Complex Molecules (>5 Impurities)

• Structured strategy for multi-impurity separation, including co-elution challenges.
• Gradient design, selectivity tuning, peak tracking, and system suitability mapping.

Module 7: Separating Impurities Along with Isomers & Diastereomers

• Advanced separation approaches for positional isomers, stereoisomers, and diastereomers.
• Use of pH, organic modifiers, and column chemistry to enhance selectivity.
• Real-case strategies for resolving closely eluting or overlapping peaks.

Module 8: Deciding System Suitability Criteria (SST)

• How to define meaningful SST parameters: Rs, tailing, RSD, plate count, retention time.
• Linking SST requirements to method intent and risk assessment.

Module 9: Impurity Calculations

• How to calculate individual impurities, total impurities, unknowns, and % area calculations.
• Relative response factors (RRF): when and how to apply them accurately.
• Acceptance criteria: regulatory expectations.

Module 10: Optimizing and Finalizing the Routine Method

• Step-by-step workflow: screening → optimisation → robustness → finalisation.
• Setting final gradients, buffer strengths, pH, flow rate, and column temperature.
• Ensuring method ruggedness for QC environments.

Module 11: Method Verification & Development Report Writing

• How to perform method verification, transfer checks, and suitability confirmation.
• Preparing a complete method development report with scientific justification and data summaries.

Module 12: Reducing HPLC Analysis Costs

• Strategies to lower the cost per analysis using:
  • Shorter columns
  • Reduced solvent usage
  • High-efficiency columns
  • Smart gradient design
• Approaches to reduce re-runs, downtime, and column damage.

Module 13: 11+ Real-World Case Studies & Expert FAQs

• Case studies covering:
  • Simple and complex impurity profiles
  • Isomer and diastereomer resolution
  • SST troubleshooting
  • Cost optimisation examples
  • Real R&D and QC industry challenges
• Detailed FAQs with problem–solution formats.
• Bonus: pro tips for handling unexpected chromatographic behaviour

3. Mastering Analytical Method Validation: Complete Training from Basics to Advanced (PharmaGuru)

Method Validation Strategy

• Definition and regulatory importance of method validation
• Pre-validation checks and readiness assessments
• Method classification (assay, impurities, dissolution, content uniformity, etc.)
• How to design a scientifically justified validation protocol
• Protocol review, circulation, and approval process

Specificity

• Why is specificity required for reliable quantification
• How to demonstrate specificity using:
  • Blank
  • Placebo
  • Known impurities
  • Stress/degradation samples
• Assessing peak purity and interference

Precision

• How to perform system repeatability (system precision)
• How to evaluate method repeatability (intra-day precision)
• How to assess intermediate precision/reproducibility using different analysts, days, and instruments
• Acceptance criteria and interpretation

Detection Limit (DL)

• Different methods for determining DL:
  • Visual evaluation
  • Signal-to-noise method
  • Standard deviation approach
• Acceptance criteria for DL
• Importance of DL in trace-level impurity detection

Quantitation Limit (QL)

• Approaches for determining QL:
  • S/N method
  • Standard deviation method
  • Calibration curve method
• Acceptance criteria for QL
• Role of QL in routine impurity quantification and limit tests

Linearity, Range & Relative Response Factor (RRF)

• Why linearity and range are essential
• Designing linearity studies (levels, replicates, concentration span)
• Evaluating slope, intercept, correlation, residuals, and ANOVA
• When and how to establish RRF for impurities
• Acceptance criteria and troubleshooting

Accuracy & Recovery

• How to perform accuracy studies at different concentration levels
• Designing recovery studies for assay and impurity methods
• Acceptance criteria for accuracy data
• Managing nonlinearity or poor recovery behaviour

Robustness

• How to select robustness parameters (pH, flow, temperature, wavelength, column, mobile phase composition, etc.)
• One-factor-at-a-time vs multivariate approaches
• How to respond to robustness failures and redesign method parameters

Stability of Solutions

• Why is solution stability required
• Study design for sample, standard, and impurity solution stability
• Acceptance criteria and justification of solution hold times

Case Studies & Conclusion

• Multiple real-world case studies (assay, impurities, stability-indicating methods)
• Example of protocol creation, execution, and documentation
• How to prepare a complete validation report
• Approval and archival process

And Much More…

• Bonus tips, troubleshooting guides, common mistakes, regulatory insights, documentation tools, checklist templates, and additional expert recommendations

4. QbD-Based Pharmaceutical Impurity Control Training: From Basics to Advanced (PharmaGuru)

Control of Chiral Impurities

• Strategies for identification, quantification, and separation
• HPLC, GC, and other analytical techniques for chiral impurity monitoring
• Regulatory requirements and best practices

Control of Achiral Impurities

• Identification and monitoring of process-related and synthetic impurities
• Analytical approaches for assay and impurity profiling
• Acceptable limits and documentation

Control of Isomeric Impurities

• Understanding positional and stereoisomeric impurities
• Methods for separation and quantification
• Role of HPLC, LC-MS, and chiral columns in impurity control

Control of Degradation Impurities

• Forced degradation studies (acid/base, thermal, oxidative, hydrolytic)
• Photostability studies and light-sensitive degradation assessment
• Designing stability-indicating methods

Control of Genotoxic Impurities

• Identification and monitoring of mutagenic/genotoxic impurities
• Threshold of Toxicological Concern (TTC) and risk assessment strategies
• Analytical and computational approaches (SAS, in-silico)

Control of Nitrosamine Impurities

• Regulatory guidelines and risk assessment for nitrosamines
• Screening, quantification, and acceptable limits
• Mitigation strategies in manufacturing and formulation

Control of Elemental Impurities

• Understanding sources of elemental impurities (ICH Q3D)
• Techniques for detection (ICP-MS, ICP-OES)
• Setting limits, monitoring, and compliance

Impurity Control Strategy

• How, where, and at what levels impurities should be controlled
• Role of TTC, SAS, and in-silico systems in impurity risk assessment
• Purge factor studies to ensure process safety and regulatory compliance

Regulatory Guidelines

• ICH guidelines (Q3A, Q3B, Q3C, Q3D, M7)
• FDA, EMA, and other global regulatory requirements
• Documentation, reporting, and approval expectations

Case Studies & Practical Learning

• 11+ real-world case studies covering all impurity types
• Practical insights into analytical method design and risk mitigation
• Interview FAQs and expert tips for real-world scenarios
• And much more… bonus troubleshooting, regulatory tips, and best practices

5. Mastering Pharmaceutical Stability & Shelf Life Evaluation: Complete Training (PharmaGuru)

Initiating Stability Studies

• How to initiate stability studies for new products or APIs
• Selecting representative batches for study
• Designing a scientifically justified stability protocol
• Regulatory expectations and approval workflow

Understanding Stability vs Retest Period vs Shelf Life vs Holding Time

• Differences between stability studies, retest period, shelf life evaluation, and holding time studies
• How each impacts product release, shelf life labelling, and regulatory compliance
• Designing studies based on product type and regulatory guidelines

Principles of Stability Studies & Shelf Life Evaluation

• Fundamental concepts behind pharmaceutical stability
• Key factors affecting product degradation: chemical, physical, and microbiological
• Guidelines for establishing shelf life based on stability data

Real-Time and Accelerated Stability Correlation

• Designing and conducting real-time vs accelerated stability studies
• Extrapolating accelerated data to predict long-term stability
• Understanding ICH Q1A(R2) correlation requirements

Role of Photostability & Forced Degradation Studies

• Importance of photostability studies in regulatory compliance
• Conducting forced degradation studies to identify degradation pathways
• Integration of results into shelf life evaluation

Role of Stability-Indicating Methods (SIM)

• How SIM supports accurate stability and shelf life evaluation
• Selection and validation of analytical methods for stability testing
• Monitoring degradation products, impurities, and potency over time

Container Closure & Packaging Interaction Studies

• Assessing the impact of packaging and container closure systems on stability
• Understanding extractables, leachables, and interaction studies
• Regulatory expectations and documentation best practices

Data Analysis, Trending & Out-of-Spec/Out-of-Trend (OOS/OOT)

• Techniques for data trending and statistical evaluation
• Investigating OOS and OOT results during stability studies
• Generating actionable insights and final reports

And Much More…

• Practical tips, case studies, troubleshooting, and expert recommendations for regulatory-compliant stability and shelf life evaluation

6. QbD-Based Analytical Control Preparation Training For Pharma Professionals (PharmaGuru)

Specifications Design Across Process Stages

• Designing analytical specifications for raw materials, reaction mixtures, intermediates, and final API
• Linking specifications to process understanding and product quality
• Regulatory expectations for stage-wise control

Trend Analysis & Purification Assessment

• Techniques to monitor trends in impurity levels across batches
• Evaluating purification efficiency at different stages
• Data-driven approaches for process optimisation

Control Strategies for Impurities

• Systematic strategies to control known and unknown impurities
• Setting critical limits and acceptance criteria
• Preventive measures and risk-based approaches

Identification & Characterisation of Unknown Impurities

• How to detect and isolate unknown impurities
• Structural characterisation using HPLC, GC, LC-MS, NMR, and other techniques
• Linking impurity identification to analytical and regulatory strategies

Impurity Control: Where, How, and at What Level

• Determining critical control points in the manufacturing process
• Establishing acceptable impurity levels based on risk assessment and regulatory guidelines
• Implementing stage-wise monitoring plans

Role of Cross-Functional Teams

• Collaborating across Analytical, QC, QA, RA, and R&D for robust control strategies
• Defining responsibilities and data ownership
• Leveraging team expertise for QbD-driven method and specification design

Applications of Analytical Control

• Applications in raw material testing, in-process monitoring, stability studies, and release testing
• Role in regulatory submissions and compliance
• Integration with PAT (Process Analytical Technology) and QbD approaches

And Much More…

• Practical case studies, troubleshooting strategies, regulatory tips, and expert insights
• Guidance on report preparation, documentation, and approval workflow
• Advanced techniques for impurity monitoring and control

7. Step-by-Step GC Method Development Training: From Fundamentals to Advanced Applications (PharmaGuru)

Comprehensive Step‑by‑Step GC Method Development Workflow

Learn the full systematic process — from defining analytical objectives to final documentation and STP preparation — for robust and reproducible GC methods.

Smart Selection of GC columns & Conditions

Master how to choose the right column, detector, carrier gas, diluent, and injection parameters tailored to your sample and target analytes.

Optimising Oven Temperature Programs

Understand how to develop and fine‑tune GC temperature programs that balance resolution, run time, and peak performance.

System Suitability & Method Validation Essentials

Learn how to set key SST criteria (resolution, plate count, tailing) and perform method verification/validation to ensure regulatory‑ready methods.

Practical Sample & Diluent Preparation Strategies

Discover best practices for sample prep — including dilution, filtration, and solvent choices — to avoid interferences and ensure reliable analysis.

11+ Real‑World Case Study Implementation

Apply your knowledge with practical GC case examples, such as separating solvents like methanol, ethanol, isopropyl alcohol, and toluene with optimised GC conditions.

Expert Tips on Troubleshooting & Optimisation

Get insider techniques to refine GC parameters (stationary phase polarity, film thickness, flow rates) for peak sharpening and improved separations.

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How?

• Mode of Delivery: Live sessions conducted via Google Meet, featuring expert-led instruction and professional presentations.
• Each Session duration: 60 to 90 minutes

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

“Enroll in More Courses — Save More with Exclusive Discounts!”

1. Titrimetric Method Development
2. Step-by-Step Guide to GC-MS Method Development
3. Step-by-Step Guide to LC-MS Method Development
4. Forced Degradation Study and Photo Stability
5. Nitrosamine Impurities: Challenges & Solutions
6. RFT Approach in Technology Transfer of Analytical Method
7. How to define pharmaceutical specifications?
8. Effective CAPA Management
9. Handling OOS, OOT and completing the investigation report

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