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Dissolution Testing in Pharma - From Development to Regulatory Approval

This course strengthens the ability to design, validate, and maintain dissolution methods that support reliable bioavailability assessment, batch consistency, and regulatory compliance. It helps teams reduce analytical variability, inspection exposure, and avoidable formulation setbacks. This Course is designed for professionals responsible for pharmaceutical formulation, analytical testing, quality oversight, and regulatory compliance activities.

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US $190 per learner

30-Days Unlimited Streaming Access

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REGISTER FOR THE COURSE

To Get 30-Day Access to ONLY this Course 

US $190 per learner
  • This course is Included in Subscription Pack
Subscription include access to entire Learning Library
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  • Instructor : Scott R. Thatcher ‎ 
  • Study time : 60 Minutes
  • Skill Level: Intermediate
  • Course ID: TF2179
  • Assessment & Certification Included
  • Ask the Expert

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About the Course

Dissolution testing plays a central role in demonstrating pharmaceutical product performance, supporting bioavailability assessment, formulation development, and ongoing quality control. Weak or inconsistent dissolution practices can create significant compliance and manufacturing concerns, including batch failures, regulatory observations, and product recalls. Regulatory expectations from FDA, USP, and ICH place increased emphasis on scientifically justified methods, reliable apparatus qualification, and consistent execution throughout the product life cycle.


The course addresses the scientific and operational factors that influence dissolution behavior, including particle size, solubility, pKa, diffusion models, excipient selection, and manufacturing conditions. Attention is also given to apparatus selection, calibration practices, discriminating method development, IVIVC evaluation, validation activities, and troubleshooting approaches linked to FDA 483 findings. These areas directly affect data reliability, submission quality, and confidence in batch-to-batch consistency during development and commercial production. The material supports phase-appropriate decision making across formulation, analytical, quality, and regulatory functions.

  • Strengthen Dissolution Method Reliability:

    Poorly designed dissolution methods can obscure formulation differences, create inconsistent analytical outcomes, and increase regulatory scrutiny. The course develops practical understanding of apparatus selection, calibration practices, diffusion principles, and discriminating method design so teams can generate reproducible data, support batch consistency, and respond more effectively to inspection or validation concerns.

  • Improve Regulatory and Development Decisions:

    Dissolution results directly influence bioavailability assessment, formulation changes, and regulatory submissions. This course clarifies expectations connected to FDA, USP <711>, ICH Q2(R2), and 21 CFR Part 211 while addressing IVIVC, validation activities, and common failure patterns. Better interpretation of dissolution data can reduce avoidable observations, rework, and delays during product development and commercial manufacturing.

Key Areas Covered

  • Scientific principles of dissolution testing and its role in pharmaceutical product performance and quality control
  • Regulatory expectations associated with FDA, USP - 711, ICH Q2(R2), ICH Q6A, and 21 CFR Part 211
  • USP Apparatus 1-7, mechanical calibration practices, and Performance Verification Testing requirements
  • Factors influencing dissolution behavior, including particle size, solubility, pKa, and diffusion layer models
  • Development of discriminating dissolution methods and establishment of reliable quality attributes
  • IVIVC evaluation and interpretation for predicting bioavailability and drug absorption behavior
  • Impact of formulation variables, excipients, polymorphism, and manufacturing processes on dissolution outcomes
  • Validation activities, life cycle management approaches, troubleshooting methods, and FDA 483 avoidance strategies

Who Must Attend

  • QA/QC Departments
  • Research & Development Teams
  • Analytical & Formulation Development Professionals
  • Regulatory Affairs & Compliance Departments
  • Manufacturing Teams
  • CMC & Process Development Professionals
  • GMP Auditors & Laboratory Scientists

Quality training, expert insights, and answers that matter. Know your Expert

SCOTT R. THATCHER

Scott Thatcher is a 20+ year veteran of the pharma and biopharma industry with experience supporting analytical method development, validation, and regulatory submissions across multiple drug programs and delivery systems. His background includes published work in analytical chemistry and photostability studies, execution of stress studies supporting hundreds of analytical methods, and direct application of ICH guidance within CMC development activities reviewed through regulatory approval processes.

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