Analytical Chemistry Techniques in Pharmaceutical Manufacturing

Length: 2 days

Analytical Chemistry Techniques in Pharmaceutical Manufacturing

The “Analytical Chemistry Techniques in Pharmaceutical Manufacturing” training course by Tonex is a comprehensive program designed to equip professionals with advanced knowledge and skills in the application of analytical chemistry techniques within the pharmaceutical manufacturing industry.

This course covers essential methodologies, regulatory requirements, and modern technologies used in quality control and assurance. Participants will gain insights into the practical aspects of analytical methods, ensuring compliance, enhancing product quality, and improving manufacturing processes.

Learning Objectives

By the end of this training course, participants will be able to:

  • Understand and apply fundamental and advanced analytical chemistry techniques in pharmaceutical manufacturing.
  • Navigate regulatory standards and guidelines relevant to pharmaceutical analysis.
  • Implement quality control measures using analytical methods to ensure product safety and efficacy.
  • Analyze and interpret data from various analytical instruments used in pharmaceutical manufacturing.
  • Troubleshoot common analytical challenges and optimize manufacturing processes.
  • Enhance laboratory practices to align with industry best practices and technological advancements.

Audience

This course is ideal for:

  • Pharmaceutical Scientists
  • Quality Control and Quality Assurance Professionals
  • Laboratory Managers
  • Regulatory Affairs Specialists
  • Process Development Engineers
  • Researchers and Academics in Pharmaceutical Sciences
  • Manufacturing and Production Managers

Program Modules

Module 1: Introduction to Analytical Chemistry in Pharmaceuticals

  • Overview of Analytical Chemistry
  • Importance in Pharmaceutical Manufacturing
  • Regulatory Frameworks and Compliance
  • Key Analytical Techniques
  • Role of Analytical Chemistry in Quality Control
  • Case Studies and Industry Examples

Module 2: Chromatographic Techniques

  • High-Performance Liquid Chromatography (HPLC)
  • Gas Chromatography (GC)
  • Thin Layer Chromatography (TLC)
  • Applications in Pharmaceutical Analysis
  • Method Development and Validation
  • Troubleshooting Chromatographic Issues

Module 3: Spectroscopic Techniques

  • Ultraviolet-Visible Spectroscopy (UV-Vis)
  • Infrared Spectroscopy (IR)
  • Nuclear Magnetic Resonance (NMR)
  • Mass Spectrometry (MS)
  • Applications in Drug Development and Quality Control
  • Data Interpretation and Analysis

Module 4: Electrochemical and Thermal Analysis

  • Potentiometry and Voltammetry
  • Conductometry
  • Differential Scanning Calorimetry (DSC)
  • Thermogravimetric Analysis (TGA)
  • Applications in Stability Testing
  • Method Optimization and Troubleshooting

Module 5: Quality Control and Assurance

  • Good Manufacturing Practices (GMP)
  • Quality by Design (QbD)
  • Statistical Quality Control (SQC)
  • Analytical Method Validation and Verification
  • Documentation and Record-Keeping
  • Case Studies in Pharmaceutical Quality Control

Module 6: Advanced Analytical Techniques and Emerging Technologies

  • Capillary Electrophoresis (CE)
  • Hyphenated Techniques (e.g., LC-MS, GC-MS)
  • Raman Spectroscopy
  • Automation and Robotics in Analytical Labs
  • Big Data and AI in Analytical Chemistry
  • Future Trends in Pharmaceutical Analysis

This structured training course by Tonex provides a blend of theoretical knowledge and practical insights, ensuring that participants are well-prepared to tackle the complexities of analytical chemistry in pharmaceutical manufacturing.