Guide and Session Pairings
Find the ISPE Guidance Document behind the sessions
ISPE GAMP® Guide: Artificial Intelligence
AI runs through more of the AM26 program than any other topic. This Guide is ISPE's framework for using artificial intelligence responsibly in GxP-regulated processes, built on the GAMP risk-based approach. It's the common reference behind 8 sessions across three tracks.
Find the Guide behind every track
Pick a track to see the Guidance Documents its sessions draw on. Every Guide is available now, so you can read up before you arrive.
ISPE Good Practice Guide: Digital Validation
How to move from paper-based validation to Digital Validation Tools while strengthening data integrity, efficiency and compliance.
GAMP® 5 Guide, 2nd Edition
The risk-based framework for compliant computerized systems, expanded for service providers, modern software development and automation.
Baseline Guide Vol 8: Pharma 4.0™
How digital and emerging technologies make manufacturing more robust and flexible, and help keep medicines reaching patients.
GAMP® Guide: Records & Data Integrity
Principles and practical guidance for keeping GxP records complete, consistent, secure, accurate and available across their life cycle.
ISPE Guide: Quality Risk Management
How to apply the revised ICH Q9(R1) expectations for quality risk management and strengthen your Pharmaceutical Quality System.
2023 ISPE Drug Shortages Prevention Model
Quality, regulatory and technical recommendations that help manufacturers prevent drug shortages before they start.
APQ Guide: Cultural Excellence
Why quality culture drives quality outcomes, and how to assess and advance cultural excellence across your organization.
ISPE Guide: 503B Compounding
Regulatory requirements and industry good practices for outsourcing facilities operating under FD&C Act Section 503B.
ISPE Guide: ATMPs – Autologous Cell Therapy
Engineering and quality considerations for manufacturing autologous cell therapies, where every batch begins with a patient.
ISPE Guide: Cleaning Validation Lifecycle
A hands-on approach to building compliant cleaning programs that meet or exceed regulatory expectations.
ISPE Good Practice Guide: Quality Laboratory Facilities
A baseline for designing quality laboratories that support GxP-regulated manufacturing, from planning through operation.
ISPE Good Practice Guide: Technology Transfer, 3rd Edition
How to transfer manufacturing processes and analytical procedures between sites and labs without losing knowledge on the way.
ISPE Guide: Sustainability
Key principles and concepts for building sustainable practices into pharmaceutical operations, whether you are starting out or scaling up.
Baseline Guide Vol 4: Water & Steam Systems
Design, construction, operation and lifecycle management of GMP water and steam systems, new and existing.
Baseline Guide Vol 3: Sterile Product Manufacturing Facilities
Engineering guidance for designing new sterile manufacturing facilities and modifying existing ones cost-effectively.
Baseline Guide Vol 6: Biopharmaceutical Manufacturing Facilities
Facility design for today’s biopharma reality: single-use technology, modular construction, focused patient populations and cost pressure.