PHARMA BIOTECH – OTC


Below are courses oriented to Pharma, Biotech, and OTC . 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 (4-day)
  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. 21 CFR 210 and 211
  2. ICH Q7
  3. Excipients GMP
  4. Understanding Combination Products for Pharmaceutical Manufacturers
  5. MHRA/EMA Rules and Guidance
  6. Quality by Design-Pharmaceutical Development
  7. ISO 17025:2017

 

Auditing Techniques

  1. Internal Auditing Workshop
  2. FDA Inspection Readiness for Pharma/Biotech
  3. FDA Readiness Inspection for Combination Products
  4. Auditing Pharma/Biotech
  5. Auditing Excipients


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. Applied 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. Best practices on complaint handling for pharma/biotech
  3. How to Write Procedures and Work Instructions to Reduce Human Errors
  4. Supplier Certification Program
  5. Change Control Systems
  6. Overview of Stability Programs for Drug, Biotech, and Combination Products
  7. APR/PQR
  8. FDA’s Quality Metrics


Training Program

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


Organizational Behavior

  1. Decision Making
  2. Critical Thinking


Employee development

  1. Certification for Pharmaceutical Operators
  2. Certification for Pharmaceutical Managers and Supervisors


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