ISPE Training Courses offer:

• Smaller class sizes with enhanced one-on-one interaction with faculty
• Courses delivered in a planned, consistent format by globally recognized professional faculty
• Continuing Education Units (CEUs) (available only in North America at this time)
• Certain courses are taught by ISPE GMPI instructors

Instructional Staff and Format
Taught and developed by globally recognized faculty, ISPE's Training Courses offer individuals smaller class sizes that provide one-on-one interaction with instructors. The professionals teaching the courses are experts in their fields bringing valuable, practical industry experience to each session. Training is offered publicly at ISPE Training events worldwide. Select training courses are available as a blended learning experience - a combination of Web-based and classroom learning.

 Consult the Global Calendar for Upcoming Training Course locations.

Training Courses

Auditing

• Auditing for GMP

21 CFR

• Complying with Part 11 - Risk Management 

Biotechnology

• Biopharmaceutical Manufacturing Facilities
• Biopharmaceutical Manufacturing Processes: A Comprehensive Overview
• Biotechnology Basics
• Downstream Bioprocessing Calculations and Strategies
• GMP Fundamentals for the Biotechnology Industry
• Microbiology for Technical Professionals
• Process Validation for Biotechnology Manufacturing
• Upstream Bioprocessing Calculations and Strategies

Business Operations

• Introduction to the US Pharmaceutical Industry
• Facility Project Management in the Regulated Pharmaceutical Industry

Commissioning and Qualification

• Basic Principles of Commissioning and Qualification 
• Application of Commissioning and Qualification

Facilities

• Facility Project Management in the Regulated Pharmaceutical Industry
• HVAC for Pharmaceutical Facilities
• Drug Manufacturing Facility Design  

GAMP

• Basic Principles of Computerized Systems Compliance
• Complying with Part 11 - Risk Management
• Practical Approach to Calibration
• Validation of Automated Equipment

GMP

• GMPs - Beyond the Fundamentals
• GMP Fundamentals for the Pharmaceutical Industry
• Understanding International GMPs

Manufacturing

• Clean in Place Fundamentals
• Cleaning Validation Principles
• Clinical Trial Materials
• Containment Fundamentals
• Implementing Process Analytical Technology
• Practical Approach to Calibration
• Q7A - Implementing Good Manufacturing Practices for Active Pharmaceutical Ingredients
• Sterile Drug Manufacturing Facilities:  Applying ISPE Baseline® Guide and FDA Guidance Principles to Design and Operation
• Technology Transfer for Active Pharmaceutical Ingredients
• Technology Transfer for Finished Dosage Forms, Oral Solids and Sterile Liquids
• Oral Solid Dosage Forms

Validation

• Basic Concepts of Validation
• Basic Principles of Computerized Systems Compliance
• Application of Computer Systems Validation
• Validation Documentation
• Validation of Automated Equipment

Water

• Pharmaceutical Water Generation
• Pharmaceutical Water Operation
• Pharmaceutical Water Systems