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.
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.
Curriculum for ISPE Training Courses
Biotechnology
- Fundamental 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
- Intermediate - Application Modern Approaches to Risk-based Commissioning and Qualification - In Development
- 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 (T04)
- Advanced Pharmaceutical Water Storage and Distribution
- 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
- Intermediate Complying with Part 11 - Risk Management: Applying the GAMP® Good Practice Guide Electronic Records and Signatures Principles (T08)
- Advanced - Application Practical Application of Computerized Systems Compliance: Applying the GAMP5® Guide: A Risk-based Approach to Compliant GxP Computerized Systems
- Advanced Validation of Automated Equipment: Applying the GAMP® VPCS Guide Principles
GMPs
- Fundamental Auditing for GMP
- Fundamental GMP Fundamentals for the Biotechnology Industry
- Fundamental GMP Fundamentals for the Pharmaceutical Industry
- Fundamental Understanding International GMP Regulations
- Advanced - Application Applying the GMPs
- Advanced Q7 – Implementing Good Manufacturing Practices for Active Pharmaceutical Ingredients
HVAC
- Advanced HVAC for Pharmaceutical Facilities
Manufacturing
- Fundamental Containment Fundamentals
- Fundamental Oral Solid Dosage Forms: Understanding the Unit Operations, Process, Equipment and Technology for OSD Manufacture
- Intermediate - Application Clinical Trial Materials: Applying Production, Quality Assurance and Packaging Processes
- Intermediate Q7 – Implementing Good Manufacturing Practices for Active Pharmaceutical Ingredients
- Intermediate Technology Transfer for API
- Intermediate Technology Transfer for Finished Dosage Forms, Oral Solids, and Sterile Liquids
- Advanced Implementing Process Analytical Technology
- 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® VPCS Guide Principles