ICH Guidelines for Product Life Cycle

• ICH Q7A – GMP Guidance for API
• ICH Q8 – Pharmaceutical Development – Quality by Design 
• ICH Q9 – Quality Risk Management
• ICH Q10 – Pharmaceutical Quality Systems

Risk Management Program

• Quality Risk Management Certification
• ICH Q9 – Quality Risk Management
• Risk Assessment Tools
• Risk Based Approach to Cleaning Validation
• Risk Based Approach & Quality by Design: Technology Transfer
• Risk Based Approach to Commissioning and Equipment Validation
• Risk Based Approach to Laboratory & Quality Systems
• Risk Based Approach to CSV

Validation Courses

• Achieving Validation Excellence-Validation Academy: 8 modules for certification
• Validation Concepts and Technical Writing Documentation
• Enhanced Commissioning & Risk Based C & Q
• Process Validation Today and Tomorrow: New FDA Guidance Draft
• Process Validation for Biotechnology Manufacturing
• Process Validation for Parenteral Manufacturing
• Process validation for Medical Device
• Process Validation for Solid Dosage Forms
• Cleaning Validation in Sterile Manufacturing
• Cleaning Validation in Non-Sterile Manufacturing
• CSV- Computer Software Validation Life Cycle
• Technology Transfer based on Design Space ICH Q8-Quality by Design and ICH Q9-Quality Risk Management
• Validation Documentation Requirements and Change Control System

Regulatory Guidance Documents

• Guidance for OTC Human Drug Products Manufacturing
• Quality Systems Inspection Techniques
• Effective Laboratory & OOS / OOT Investigations
• Introduction to PAT
• 21 CFR Part 11
• Sterile Drug Product Produced by Aseptic Processing
• Stability Testing Guidance
• SUPAC and CDER Guidelines applications on Technology Transfer
• Bar Code & Labeling Requirements
• Process Validation Guideline
• Cleaning: Regulatory Requirements & Inspection Approaches
• Impact of Non-Compliance in Biotechnology Industries

 Microbiology

• Microbiology Certification program
• Microorganism Identification
• Environmental Monitoring Program & Control
• Aseptic Techniques
• Microbiology Controls in Pharmaceutical Water Systems
• Sterility Test
• Microbiology Investigations

Regulatory Enforcement

• In-Depth Analysis of WLs and CDs in the industry
• FDA Inspection Readiness
• In-Depth Evaluation of Quality Failures in the Pharmaceutical Industry
• FDA Regulatory Actions Enforcement

Quality Systems

• ICH Q 10 Pharmaceutical Quality Systems
• Annual Plant cGMPs
• Technical Writing for Pharmaceutical Professionals
• How to Structure Effective SOPs & Train Personnel
• Good Documentation Practices
• Root Cause Analysis and Problem Solving Techniques for Investigations
• Conducting and Writing Investigations: Effective Investigation Techniques and Technical Writing
• Effective Technical Writing Report Preparation
• Developing Effective Corrective Actions and Preventive Actions (CAPA)
• Effective Change Control System
• Regulatory Requirements and Compliance Processes for Medical Devices.
• How to Implement Effective Quality Systems
• How to Improve the Batch Record Auditing Process
• Compliance Auditing: How to Conduct Effective Audits

Lean Six Sigma / Process Excellence and Continuous Improvement Series

• Introduction to 6 Sigma and Process Excellence
• Six Sigma for World Class Manufacturing 
• Six Sigma Green Belt Certification
• Six Sigma Black Belt Certification 
• Application of Six Sigma in Validation Life Cycle
• Building a Lean Thinking Culture
• Introduction to Statistics
• Introduction to Process Capability
• Introduction to Design of Experiments
• Introduction to SPC & Process Capability for Continued Process Verification

cGMPs

• ICH Q 7A – GMP Guidance for API
• cGMPs Applied to Processing Areas
• cGLPs Applied to Laboratory Areas
• cGMPs Applied to Engineering Areas
• cGMPs Applied to Material Control Areas
• Personnel & Quality Management Responsibilities
• Building a Quality Compliance Culture
• Good Documentation Practices for Drug and Food Industries
• Good Laboratory Practices (GLP’s)

Computer Systems

• Microsoft Network Administration
• Microsoft Programming
• Microsoft Office (Word, Excel, PowerPoint, Outlook, Visio, Project and others)
• Other technology software courses (Macromedia, Adobe, Lotus Notes, and others)

Safety

• OSHA Recordkeeping
• Accident Investigation Safety
• Safety Audits
• Hazwoper
• Emergency Response
• Hazard Communication Safety
• Department of Transportation
• Forklift Operator Safety Certification
• Lockout/Tagout
• OSHA Construction
• OSHA General Industry
• Hazcom

Project Management

• Project Management Certification; Preparation Course
• Developing a Project applying the Project Management Methodology (PMIR)
• Enterprise Program Management Office: The Center of Excellence (EPMO)
• Facilitating Project Management with MS Project

Other Seminars

• Engineering for Non-Engineers
• Labor Law Series
• Conversational English
• Business Writing
• Ergonomics
• Workplace Violence
• CPR
• Food Safety Certification