Training and Coursework

Full Day Courses

These courses can be presented at your site, with up to 30 attendees.  They are designed to be interactive, and can be tailored to your needs or incorporate examples from your company.  Attendees will be invited to submit questions prior to or during the course.

  • Analytical Methods:  QbD for Method Development; Validation/Verification/Transfer
  • Dissolution:  Method Development, Troubleshooting, Instrument Qualification
  • Control of Impurities in Pharmaceutical Products:  Impurities, Degradants, Residual Solvents, Elemental Impurities
  • Analytical Instrument Qualification
  • Effective Investigation of Out of Specification, Out of Trend or Atypical Results
  • Getting the Most Out of the USP:  How to use it effectively; how to monitor and influence changes

Shorter Topics (1.5 – 2 Hours)

  • Lean Approaches To Development Of HPLC Methods For Drug Products
  • Validation of Analytical Procedures Using a Lifecycle Approach
  • Verification of Compendial Procedures
  • A Practical Approach to Dissolution Method Development
  • Troubleshooting Dissolution Methods or Aberrant Results
  • Qualification of the Dissolution Apparatus:  Mechanical Calibration vs Performance Verification
  • Analytical Instrument Qualification:  An Overview of USP <1058>
  • Understanding and Applying ICH Q3A and Q3B for Control of Impurities in Drug Substances and Drug Products
  • Elemental Impurities:  Current Status of Evolving Requirements
  • Residual Solvents: Understanding the Requirements and Strategies for Compliance
  • An Introduction to the FDA Quality Control Requirements for Dietary Supplements (21 CFR Part 211)
  • Setting up Quality Systems for the Pharmaceutical Laboratory
  • Writing Effective SOPs for the Pharmaceutical Laboratory
  • Preparing for a Laboratory Inspection
  • Getting the Most Out of the USP
  • Conducting Effective OOS Investigations Using Root Cause Analysis
  • Laboratory Weighing:  Recent Revisions to USP General Chapters <41> and <1251>

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