ISPE Education and Training Library

A complete list of ISPE's Education and Training Offerings.

Key to Symbols:

•  Conference Seminar
•  Training Course
•  Webinar: Live or Recorded

• 17th Annual Barrier Isolation Technology Forum: Innovation Updates and New Case Studies
• Airflow Pattern Visualization
• Application of Commissioning and Qualification
• Application of Computer Systems Validation
• Aseptic Processing: Fourth Annual Aseptic Manufacturing Technology Symposium
• Auditing for GMP
• Automation and Process Control: Smart Approaches for Implementing State-of-the-Art Technologies
• Barrier Technology
• Basic Concepts of Validation
• Basic Containment Terminology and Techniques
• Basic Principles of Commissioning and Qualification
• Basic Principles of Computerized Systems Compliance
• Benchmarking Pharmaceutical Engineering and Management Costs
• Biopharmaceutical Inspections - The FDA Approach
• Biopharmaceutical Manufacturing Facilities
• Biopharmaceutical Manufacturing Processes: A Comprehensive Overview
• Biotechnology Basics
• Biotechnology Facility Delivery: From Concept to License
• Blinded by Science - Functional and Unique Approaches to Blinding Clinical Trial Materials
• Clean in Place Fundamentals
• Cleaning
• Cleaning Validation Principles
• Clinical Trial Materials
• Clinical Trials: A Primer
• Commissioning and Qualification and the ASTM
• Commissioning and Qualification Risk based Approach and the Baseline Guide Update
• Complying with Part 11 - Risk Management
• Containment Fundamentals
• Containment Technologies Forum: Concepts, Case Studies and Compliance
• CPIP Preparation: Commissioning and Qualification as a Risk Management Strategy
• CPIP Preparation: Controls and Automation
• CPIP Preparation: Design and Construction/Installation
• CPIP Preparation: Formulation, Clinical Phases, and Manufacture
• CPIP Preparation: Government Regulations - COMING SOON
• CPIP Preparation: Information Systems
• CPIP Preparation: Materials Management
• CPIP Preparation: Operation Maintenance
• CPIP Preparation: Operational Economics - COMING SOON
• CPIP Preparation: Production Control - COMING SOON
• CPIP Preparation: Production Management
• CPIP Preparation: Production Scale-up and Optimization
• CPIP Preparation: Production Unit Operations - drug (small molecule) and biologics
• CPIP Preparation: Risk Management and Quality Management Systems
• CPIP Preparation: Standards, Practices, and Guides
• CPIP Preparation: Systems Validation
• CPIP Preparation: Technology Transfer
• CPIP Preparation: Warehouse and Distribution Management
• Deploying RFID in Pharmaceutical Manufacturing and Supply Chain Operations
• Designing and Validating Manufacturing Execution Systems
• Distribution of Clinical Supplies to Emerging Economies
• Downstream Bioprocessing Calculations and Strategies
• Drug Manufacturing Facility Design
• Equipping SMEs to Perform Effective Training
• ER&S(Part 11) GAMP Quality Management System - ICH Q10, QbD and QMS for Computerised Systems
• European Clinical Trial Directive - An Update on Practical Aspects
• Facilities Summit
• Facility Project Management in the Regulated Pharmaceutical Industry
• FDA Discusses Regulatory Aspects of the Biopharmaceutical Baseline Guide
• GAMP 5 – 2 days New GAMP5- Enabling Innovation and Technological Advance
• GAMP® 5: New Practical Guidance Document for Computer Systems Compliance
• GAMP® Good Practice Guide: Validation of Laboratory Computerized Systems
• GMP Fundamentals for the Biotechnology Industry
• GMP Fundamentals for the Pharmaceutical Industry
• GMPs - Beyond the Fundamentals
• GMPs for the Contractor
• Going Modular - A Paradigm Shift in Pharmaceutical Facility Design and Delivery
• HVAC for Pharmaceutical Facilities
• Implementing Off-The-Shelf CTM Systems: Avoiding the Pitfalls
• Implementing Process Analytical Technology
• Innovations in API / BPC
• Innovations in OSD Processing
• Introduction and Update on ISPE's New Risk-MaPP Baseline® Guide
• Introduction to the US Pharmaceutical Industry
• Investigational Products
• Labs of the Future
• Leveraging Commissioning to Support a Risk-Based Approach to Qualification
• Lyophilization: Meeting the Challenges of a Critical Technology
• Managing Offshore Outsourced Software Development
• Manufacturing of Potent Drugs - An Industry Perspective on Facility Design, Measurements and Controls, as Presented to the FDA
• Metrics for Clinical Supplies Operations
• Microbiology for Technical Professionals
• New Drug Delivery Systems
• Oral Solid Dosage Forms
• PAT (Including Poster Session)
• Pfizer Case Study - Using a Balanced Scorecard to Drive Continuous Improvement
• Pharma HVAC Energy and Life Cycle Cost Controls
• Pharmaceutical Water Generation
• Pharmaceutical Water Operation
• Pharmaceutical Water Systems
• Plenary – New Paradigms in Processing & Operations
• PQLI (Product Quality Lifecycle Implementation)
• Practical Approach to Calibration
• Presented by the FDA - The Quality Systems Approach to Pharmaceutical cGMP Regulations
• Process Validation for Biotechnology Manufacturing
• Process Validation: Today's Practices and Tomorrow's Opportunities
• Proposed Revision to FDA Guideline on the Preparation of Investigational Products (Human and Animal)
• Q7A - Implementing Good Manufacturing Practices for Active Pharmaceutical Ingredients
• Regulatory Perspectives on Hot Topics, Regulatory Trends, and Observations
• Risk Management in a Regulatory Context: Overview and Examples
• Risk-MaPP: Workshop on the Tools and Application of the New Risk-MaPP ISPE Baseline® Guide
• Selected Topics in Critical Utilities – Water, Steam and Gases
• Single-Use Manufacturing Technology: Selection, Implementation, and Validation
• South of the Border: Clinical Supply Challenges in South America
• Stability Evaluation and Retest Dating of Clinical Trial Materials (Investigational Medicinal Products)
• Sterile Drug Manufacturing Facilities: Applying ISPE Baseline® Guide and FDA Guidance Principles to Design and Operation
• Sterile Drug Products by Aseptic Processing: The New FDA Guidance
• Technology Transfer
• Technology Transfer for Active Pharmaceutical Ingredients
• Technology Transfer for Finished Dosage Forms, Oral Solids and Sterile Liquids
• The GAMP® Risk-Based Approach to Electronic Records and Signatures
• The Impact of PAT-oriented Process Development and Manufacturing Operations on Data Management
• Top Five Critical Issues Facing the PAT Professional
• Understanding International GMPs
• Upstream Bioprocessing Calculations and Strategies
• Validation Documentation
• Validation of Automated Equipment

ISPE's Conferences help professionals keep current with emerging global industry trends and practices.

Through interactive seminars, workshops, and case studies, participants can keep on the cutting edge by learning about regulatory updates and new technology. Conferences allow for peers to share common problems and co-develop solutions through a variety of networking activities and interaction with regulatory officials.

Instructional Staff and Format
Taught by recognized industry leaders who have successfully faced the challenges in today's healthcare technology arena, Conferences offer an ideal opportunity to network with leaders in the industry and catch up with colleagues. In addition, the interactive programs offer extensive question and answer sessions which provide an excellent forum for colleagues to share best practices.

 Consult the Global Calendar for Upcoming Conferences

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.

ISPE's Webinars

Get industry know-how 24/7 from the convenience of a computer with Internet access. ISPE Web-based education provides the knowledge, skills, and best practices you need for job success today and into the future.

 Learn more about ISPE's Webinars.