Below are our courses oriented to API. To see a complete listing of all training and educational courses we offer, please download our Education Catalog. 

ASQ Certification Academies

  1. ASQ Certified Quality Auditor
  2. ASQ Certified GMP Professional
  3. ASQ Certified Quality Engineer

Investigations and Effective CAPA Systems

  1. Investigation and Effective CAPA Systems Certification
  2. CAPA Effectiveness
  3. Root Cause Analysis, CAPA, and Compliance Writing
  4. Effective CAPA Systems Management Overview
  5. Effective OOS Investigations and CAPA for QC Analytical Laboratory


Human Error Investigation and Prevention

  1. Human ERROR Certification
  2. Overview of Human Error


Regulations and Standards

  1. Q7
  2. Excipients GMP
  3. MHRA/EMA Rules and Guidance

Auditing Techniques

  1. Internal Auditing Workshop
  2. FDA Inspection Readiness for API
  3. Auditing APIs
  4. Auditing Excipients

Technical and Compliance Writing

  1. How to Write Effective CAPA Investigation Reports
  2. How to Write Effective Regulatory Documents
  3. Effective Compliance Writing

Risk Management

  1. Quality Risk Management Certification
  2. Practical FMEA for the FDA-Regulated Industry


  1. Analyzing and Trending Data
  2. Basic Applied Statistics with Minitab
  3. Sampling Best Practices for the FDA-Regulated Industry
  4. Design of Experiments

Lean and Six Sigma

  1. Poka-Yoke
  2. 5S
  3. Six Sigma Green Belt certification


  1. Computer System Validation for the FDA-Regulated Industry
  2. Validation Overview
  3. Cleaning Validation Lifecycle
  4. Facilities and Critical Utilities Systems Qualification
  5. Laboratory Equipment Qualification
  6. General Concepts of Thermal, Radiation, Chemical and Filtration Sterilization Validation
  7. Test Method Validation


  1. Data Integrity Certification
  2. How to Write Procedures and Work Instructions to Reduce Human Errors
  3. Supplier Certification Program
  4. Change Control Systems
  5. Stability Programs for APIs
  6. Best practices on complaint handling for APIs

Training Program

  1. Train the Trainer
  2. How to Measure Training Effectiveness

Organizational Behavior

  1. Decision Making
  2. Critical Thinking

Employee development

  1. Certification API Plant Operators
  2. Certification API Plant Managers and Supervisors

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