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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Current Training Courses

Auditing

• Auditing for GMP

21CFR

• 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