COMBINATION PRODUCTS


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


Statistics

  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


Validations

  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


Compliance

  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


Contact Us to Receive a Quote