Training

As a Membership-based organization, ISPE draws from the expertise of its Members to develop training courses that address your current needs to meet industry demands. Our instructors work in the industry and face the same daily challenges you do. Gain solutions to your company’s immediate goals to lower production costs, improve process efficiency, increase production quality, and meet regulatory requirements.

See the Global Calendar for Upcoming Training Course locations.

On-site Training

ISPE will customize an on-site training program to help you meet specific employee productivity and knowledge requirements. The program will cost less than sending groups to off-site training and can work to fit employee work schedules. Most of courses are two days and can accommodate up to 30 participants.

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Curriculum for ISPE Training Courses

Biotechnology
Fundamental - Application	Biotechnology Basics
Fundamental	GMP Fundamentals for the Biotechnology Industry
Fundamental	Microbiology for Technical Professionals
Intermediate	Biopharmaceutical Manufacturing Processes: A Comprehensive Overview
Advanced - Application	Biopharmaceutical Manufacturing Facilities: : Applying the Biopharmaceutical Manufacturing Facilities Baseline® Guide Principles
Advanced	Downstream Bioprocessing Calculations and Strategies
Advanced	Process Validation in Biotechnology Manufacturing
Advanced	Upstream Bioprocessing Calculations and Strategies

Cleaning
Fundamental	Clean in Place Fundamentals
Intermediate	Cleaning Validation Principles

Commissioning and Qualification
Fundamental	Basic Principles of Commissioning and Qualification: Applying the Commissioning and Qualification Baseline® Guide Principles
Advanced - Application	Application of Commissioning and Qualification: Applying the Commissioning and Qualification Baseline® Guide Principles

Facilities
Fundamental	Basic Principles of Commissioning and Qualification: Applying the Commissioning and Qualification Baseline® Guide Principles
Fundamental	Clean in Place Fundamentals
Fundamental	Drug Manufacturing Facility Design and Development
Intermediate - Application	Facility Project Management in the Regulated Pharmaceutical Industry
Intermediate	Sterile Drug Manufacturing Facilities: Applying ISPE Baseline® Guide and FDA Guidance Principles to Design and Operation
Advanced - Application	Application of Commissioning and Qualification: Applying the Commissioning and Qualification Baseline® Guide Principles
Advanced	HVAC for Pharmaceutical Facilities
Advanced	Pharmaceutical Water Generation
Advanced	Pharmaceutical Water Operation: Storage, Distribution, System Operation and Validation
Advanced	Pharmaceutical Water Systems (EU Only): Regulation, Purification, Distribution and Validation

GAMP
Fundamental	Basic Principles of Computerized Systems Compliance: Applying the GAMP5® Guide: A Risk-based Approach to Compliant GxP Computerized Systems
Advanced - Application	Practical Application of Computerized Systems Compliance: Applying the GAMP5® Guide: A Risk-based Approach to Compliant GxP Computerized Systems
Intermediate	Complying with Part 11 - Risk Management: Applying the GAMP® Good Practice Guide Electronic Records and Signatures Principles
Advanced	Validation of Automated Equipment: Applying the GAMP® VPCD Guide Principles

GMPs
Fundamental	GMP Fundamentals for the Biotechnology Industry
Fundamental	GMP Fundamentals for the Pharmaceutical Industry
Fundamental	Understanding International GMPs Regulations
Fundamental	Auditing for GMP
Advanced - Application	Applying the GMPs
Advanced	Q7A – Implementing Good Manufacturing Practices for Active Pharmaceutical Ingredients

HVAC
Advanced	HVAC for Pharmaceutical Facilities

Manufacturing
Fundamental	Containment Fundamentals
Intermediate	Q7A – Implementing Good Manufacturing Practices for Active Pharmaceutical Ingredients
Intermediate - Application	Clinical Trial Materials: Applying Production, Quality Assurance and Packaging Processes
Intermediate	Technology Transfer for Finished Dosage Forms, Oral Solids and Sterile Liquids
Intermediate	Technology Transfer for API
Advanced	Implementing Process Analytical Technology
Advanced	Oral Solid Dosage Forms: Process Monitoring Techniques and Challenges in Scale-Up and Technology Transfer
Advanced	Practical Approach to Calibration: Applying the GAMP® Good Practice Guide: Calibration Management Principles

Validation
Fundamental	Basic Concepts of Validation
Fundamental	Validation Documentation
Advanced	Cleaning Validation Principles
Advanced	Process Validation in Biotechnology Manufacturing
Advanced - Application	Validation of Automated Equipment: Applying the GAMP® VPCD Guide Principles

Water
Intermediate	Pharmaceutical Water Generation
Intermediate	Pharmaceutical Water Operation: Storage, Distribution, System Operation and Validation
Intermediate	Pharmaceutical Water Systems (EU Only): Regulation, Purification, Distribution and Validation