API
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
- ASQ Certified Quality Auditor
- ASQ Certified GMP Professional
- ASQ Certified Quality Engineer
Investigations and Effective CAPA Systems
- Investigation and Effective CAPA Systems Certification
- CAPA Effectiveness
- Root Cause Analysis, CAPA, and Compliance Writing
- Effective CAPA Systems Management Overview
- Effective OOS Investigations and CAPA for QC Analytical Laboratory
Human Error Investigation and Prevention
- Human ERROR Certification
- Overview of Human Error
Regulations and Standards
- Q7
- Excipients GMP
- MHRA/EMA Rules and Guidance
Auditing Techniques
- Internal Auditing Workshop
- FDA Inspection Readiness for API
- Auditing APIs
- Auditing Excipients
Technical and Compliance Writing
- How to Write Effective CAPA Investigation Reports
- How to Write Effective Regulatory Documents
- Effective Compliance Writing
Risk Management
- Quality Risk Management Certification
- Practical FMEA for the FDA-Regulated Industry
Statistics
- Analyzing and Trending Data
- Basic Applied Statistics with Minitab
- Sampling Best Practices for the FDA-Regulated Industry
- Design of Experiments
Lean and Six Sigma
- Poka-Yoke
- 5S
- Six Sigma Green Belt certification
Validations
- Computer System Validation for the FDA-Regulated Industry
- Validation Overview
- Cleaning Validation Lifecycle
- Facilities and Critical Utilities Systems Qualification
- Laboratory Equipment Qualification
- General Concepts of Thermal, Radiation, Chemical and Filtration Sterilization Validation
- Test Method Validation
Compliance
- Data Integrity Certification
- How to Write Procedures and Work Instructions to Reduce Human Errors
- Supplier Certification Program
- Change Control Systems
- Stability Programs for APIs
- Best practices on complaint handling for APIs
Training Program
- Train the Trainer
- How to Measure Training Effectiveness
Organizational Behavior
- Decision Making
- Critical Thinking
Employee development
- Certification API Plant Operators
- Certification API Plant Managers and Supervisors