ISPE's instructor-led GAMP® Basic Principles course comes to Berlin for two days — – — updated to the revised GAMP® 5 Second Edition for computerized-systems compliance.
Dates and format
- Date: 8-9 December 2026
- Format: in person, two days
- Venue: JW Marriott Hotel Berlin, Stauffenbergstr. 26, Berlin, 10785, Germany
- Organizer: International Society for Pharmaceutical Engineering (ISPE)
What it covers
A fundamentals course introducing the regulatory requirements for computerized systems across the pharmaceutical, biotech and medical device industries, updated to include the revised GAMP® 5 Second Edition. ISPE's course catalog lists topics including regulations and regulators, requirements of 21 CFR Part 11, an overview of GAMP® 5, the GAMP® 5 lifecycle in detail, and quality risk management and testing. For sterile-facility GMP in the same ISPE training line, ISPE's GMP Sterile Pharmaceutical Manufacturing Facility course covers adjacent ground, and PDA's Annex 1 Implementation Workshop, also in Europe this December, covers a related contamination-control standard.
Who should attend
Quality, IT and regulatory affairs staff responsible for computerized-systems compliance and validation under GAMP 5, 21 CFR Part 11 and EU Annex 11, including teams preparing systems for inspection. The full events directory lists other ISPE, PDA and DIA sessions we have verified on GMP, quality systems and computerized-systems validation.
Frequently asked questions
When does ISPE's GAMP Basic Principles course run in Berlin?
8-9 December 2026, in person at the JW Marriott Hotel Berlin, Stauffenbergstr. 26, Berlin, 10785, Germany.
What does the course cover?
The regulatory requirements for computerized systems in the pharmaceutical, biotech and medical device industries, updated to include the revised GAMP® 5 Second Edition, alongside 21 CFR Part 11 and quality risk management topics.
What does it cost?
ISPE's course page lists Member US$1,960, Nonmember US$2,260, Government/Academia/Emerging Economies US$550, and Student US$90; ISPE membership is required for member pricing, and group discounts apply for 3 or more registrants. Confirm the rates apply to this specific Berlin session before registering.
Who should attend?
Quality, IT and regulatory affairs staff responsible for computerized-systems compliance and validation under GAMP 5, 21 CFR Part 11 and EU Annex 11.
Sources & further reading
- ISPE. GAMP® Basic Principles 2-Day Training Course, 8-9 Dec 2026, Berlin. ispe.org
- ISPE. 2026 ISPE December Online Live Training (GAMP® Basic Principles, Berlin listing). ispe.org
Event details are published by the organizer and can change. Confirm dates, format, fees and access with ISPE before making plans. Verified via WebSearch corroboration against two of ISPE's own pages (direct organizer-page fetch was blocked this session) — last checked 16 October 2026.
