Below are our courses oriented to Combination Products. 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 Biomedical Auditor
  4. ASQ Certified Quality Inspector Academia
  5. 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. Medical Device Quality System Expert Certification
  2. 21 CFR 820
  3. 21 CFR 211
  4. Understanding Combination Products for Pharmaceutical Manufacturers
  5. Understanding Combination Products for Medical Device Manufacturers
  6. ISO 13485-2016

Auditing Techniques

  1. Internal Auditing Workshop
  2. FDA Readiness Inspection for Combination Products
  3. Auditing Combination Products

Technical and Compliance Writing

  1. How to Write Effective CAPA Investigation Reports
  2. 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. Essential Elements for the Manufacture for Aseptically Produced Sterile Products
  5. Facilities and Critical Utilities Systems Qualification
  6. Laboratory Equipment Qualification
  7. General Concepts of Thermal, Radiation, Chemical and Filtration Sterilization Validation
  8. Test Method Validation


  1. Data Integrity Certification
  2. How to Write Procedures and Work Instructions to Reduce Human Errors
  3. Supplier Certification Program
  4. Medical Device Design Controls
  5. Change Control Systems
  6. Overview of Stability Programs for Drug, Biotech, and Combination Products
  7. FDA’s Quality Metrics
  8. Best practices on complaint handling for pharma/biotech
  9. Best practices on complaint handling for medical devices

Training Program

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


Organizational Behavior

  1. Decision Making
  2. Critical Thinking

Employee Development

  1. Certification Pharmaceutical Operators
  2. Certification Pharmaceutical Managers and Supervisors
  3. Certification Medical Devices Operators
  4. Certification Medical Devices Managers and Supervisors

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