2026 ISPE December Online Live Training
Deep Dive into Pharma Training Courses
Gain solutions to your company's immediate goals to lower production costs, improve process efficiency, increase production quality, and meet regulatory requirements.
- Real World Practice: Courses present exercises that use current problems and situations common to the industry.
- Experienced Instructors: Subject matter experts and top leaders in the pharmaceutical industry who have years of experience in their field of study.
- Global Training to Fit Your Needs: With eLearning
In-Person Training Events Online Live Training Events
In-Person Training Events
GAMP® Basic Principles
8 - 9 Dec 2026
This course has been updated to include the new revised GAMP® 5 Second Edition. This fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical, biotech, or medical device industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements, by building upon existing industry good practice in an efficient and effective manner.
Guide Resource
Training Venue:
JW Marriott Hotel Berlin
Stauffenbergstr. 26,
Berlin, 10785, Germany
Hotel & Reservations: +49 30 2065 1086
Instructor
Online Live Training Events
GAMP® 5, Annex 11/Part 11 Basic Principles
1 - 3 Dec 2026
This course has been updated to include the new revised GAMP® Second Edition as well as a discussion on the application of AI/ML. This fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical, biotech, or medical device industry and explores tried, tested, and internationally recognized methods of meeting those requirements.
Instructor
Pharmaceutical Water Systems
7 - 9 Dec 2026
This course has been substantially updated to feature the guiding principles of the ISPE Baseline Guide: Water and Steam Systems (Second Edition) with particular emphasis placed upon microbial control and laboratory water as well as key design philosophies. The principles of design and operation of water systems used directly in pharmaceutical manufacturing and laboratory applications, including the essential concepts and principles of systems used to generate USP, EP and non-compendial waters, will be covered. These concepts include specification, design, operation, testing, and maintenance of equipment and systems for water generation.
Instructor
ATMP Manufacturing
14 - 17 Dec 2026
This course is focused on the commercial manufacture of Advanced Therapy Medicinal Products (ATMPs) drug products in manufacturing facilities. The purpose of this course is to focus on facility engineering issues and how to provide cost-effective facilities to ensure that products of the highest quality are consistently manufactured, as defined in the new Good Practice Guide. This course stays at the facility level and establishes guiding principles from the GPG that should be considered during these emerging and rapidly evolving times. This course is written from the perspective of an allogeneic or autologous cellular therapy or gene-modified cellular therapy.
Instructor
GAMP® Data Integrity
7 - 9 Dec 2026
This GAMP Data Integrity 21 CFR Part 11 Training Course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems to provide the tools and techniques to implement proper controls for data.
Instructor
Commissioning and Qualification
8 - 11 Dec 2025
Through interactive workshops, this course will explain and apply the science and risk-based approach to integrated lifecycle Commissioning & Qualification by conducting verification of systems, equipment and facilities in accordance with the recently issued 2nd Edition Guide, ICH documents Q8 (R2), Q9, and Q10, current Regulatory Guidance, industry best practices, and ASTM E2500.
Instructor
Good Engineering Practice (GEP) - Registration Coming Soon
14 - 17 Dec 2026
This course considers the entire range of pharmaceutical engineering activity and identifies key attributes of GEP within it, including how GEP relates to and interfaces with GxP. The scope of GEP covers the complete lifecycle of engineering projects and engineered systems from conceptual design to retirement. GEP provides a foundation required across the pharmaceutical industry that other areas, such as GxP build upon.
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