Curriculum for ITBD Training Courses

 Pharmaceutical training we may arrange for your team

Pharmaceutical Marketing

• The Pharmaceutical Brand Planning Course
• The Pharmaceutical Business Development Course
• The Strategic Digital Pharmaceutical Marketing Course
• The Pharmaceutical Forecasting Course
• Licensing Marketed Pharmaceuticals
• Late Stage Pharmaceutical Lifecycle Management
• Essentials of Pharmaceutical Pricing

Pharmaceutical International Marketing

• Principles of Pharmaceutical Market Access in Europe / North America / South America
• The Pharmaceutical Licensing Negotiation Master Class
• The Pharmaceutical Out-licensing Course

Biotechnology

• An Overview of Biopharmaceutical Manufacturing Processes
• Applying the Biopharmaceutical Manufacturing Facilities Baseline Guide Principles
• Biotechnology Basics
• Process Validation in Biotechnology Manufacturing

Cleaning

• Clean in Place Fundamentals
• Cleaning Validation Principles

Commissioning and Qualification

• Application of Commissioning and Qualification: Applying the Commissioning and Qualification Baseline Guide Principles
• Basic Principles of Commissioning and Qualification: Applying the Commissioning and Qualification Baseline Guide Principles
• Science and Risk-based Commissioning and Qualification - Applying the Good Practice Guide: Applied Risk Management for Commissioning and Qualification

Facilities

• Application of Commissioning and Qualification: Applying the Commissioning and Qualification Baseline Guide Principles
• Basic Principles of Commissioning and Qualification: Applying the Commissioning and Qualification Baseline Guide Principles
• Clean in Place Fundamentals
• Control for Critical Environments: HVAC Design Concepts
• Drug Manufacturing Facility Design and Development
• Facility Project Management in the Regulated Pharmaceutical Industry
• Pharmaceutical Water Generation
• Pharmaceutical Water Systems
• Science and Risk-based Commissioning and Qualification - Applying the ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification
• Sterile Product Manufacturing Facilities: Applying the new GMP Baseline Guide and FDA Guidance Principles to Design and Operation
• Storage Delivery and Qualification of Pharmaceutical Waters

GAMP

• A Risk-Based Approach to GxP Process Control Systems: Applying the GAMP Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems
• Basic Principles of Computerized Systems Compliance using GAMP
• Basic Principles of Computerized Systems Compliance: Applying the GAMP5 Guide: A Risk-based Approach to Compliant GxP Computerized Systems
• Complying - Risk Management: Applying the GAMP Good Practice Guide Electronic Records and Signatures Principles
• Practical Application of Computerized Systems Compliance: Applying the GAMP Guide: A Risk-based Approach to Compliant GxP Computerized Systems

GMPs

• Applying the GMPs
• GMP Auditing for the Pharmaceutical Industry
• GMP Fundamentals for the Pharmaceutical Industry
• Q7A: Implementing Good Manufacturing Practices

HVAC

• Control for Critical Environments: HVAC Design Concepts

Manufacturing

• Applying Quality Risk Management (QRM)
• Clinical Trial Materials: Applying Production, Quality Assurance and Packaging Processes  Implementing Process Analytical Technology
• Managing the Risk of Cross Contamination: Applying the Risk-MaPP Baseline Guide
• Oral Solid Dosage Forms: Understanding the Unit Operations, Process, Equipment and Technology for OSD Manufacture
• Q7A: Implementing Good Manufacturing Practices
• Turning QbD into a Practical Reality

Quality by Design

• Implementing Process Analytical Technology
• Process Validation Lifecycle Principles and Integration to the Pharmaceutical Quality System - New Course!
• Turning QbD into a Practical Reality

Validation

• A Risk-Based Approach to GxP Process Control Systems: Applying the GAMP Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems
• Cleaning Validation Principles
• Process Validation in Biotechnology Manufacturing

Water

• Pharmaceutical Water Generation
• Pharmaceutical Water Systems
• Storage Delivery and Qualification of Pharmaceutical Waters