ISPE's instructor-led course on GMP sterile manufacturing facilities runs online over four mornings — – — built on its own Baseline Guide and FDA's aseptic processing guidance.

Dates and format

  • Date: 9-12 November 2026, four mornings
  • Format: Online Live, 0830-1230 EDT login through wrap-up each day
  • Organizer: International Society for Pharmaceutical Engineering (ISPE)
  • Instructors: Norman Goldschmidt, Andrew Collentro, Briar A. Colwell, Jeffery Odum, Steven Wisniewski

What it covers

The course works through GMP requirements for sterile product manufacturing facilities, built on ISPE's own Baseline Guide for sterile product manufacturing facilities and FDA's guidance on sterile drug products produced by aseptic processing. It is pitched at an intermediate level (ISPE course code T12) and carries 1.3 ISPE continuing education units. For hands-on, equipment-level training in the same area, ISPE's webinar on scalability in commissioning, qualification and validation covers adjacent ground.

Who should attend

Quality and manufacturing engineers, facility designers and regulatory affairs staff responsible for GMP compliance in sterile drug product facilities, including teams preparing for FDA aseptic processing inspections. For broader context on the same facility type, PDA's Pharmaceutical Microbiology Conference covers adjacent contamination-control ground, and the full events directory lists other ISPE, PDA and FDA sessions we have verified on sterile manufacturing and aseptic processing.

Frequently asked questions

When does ISPE's GMP Sterile Pharmaceutical Manufacturing Facility course run?

9-12 November 2026, Online Live, with each day running from an 0830 login to a 1230 wrap-up (times in EDT).

Who teaches it?

ISPE lists five featured instructors for this course: Norman Goldschmidt, Andrew Collentro, Briar A. Colwell, Jeffery Odum and Steven Wisniewski.

What does the course cover?

GMP requirements for sterile product manufacturing facilities, built on the ISPE Baseline Guide for sterile product manufacturing facilities and FDA's guidance on aseptic processing. It is an intermediate-level course (ISPE course T12) worth 1.3 ISPE CEUs.

What does it cost?

ISPE's course page lists Member US$1,630 / Nonmember US$1,930 before the early-bird deadline, rising to Member US$1,930 / Nonmember US$2,230 after; students pay US$90. ISPE membership is required for member pricing. Confirm current rates on ISPE's course page, since the published early-bird date had already passed as of this listing's verification.

Sources & further reading

  1. ISPE. 2026 ISPE November Training (GMP Sterile Pharmaceutical Manufacturing Facility, 9-12 Nov 2026). ispe.org
  2. ISPE. GMP Sterile Pharmaceutical Manufacturing Facility Training Course (T12). 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 11 October 2026.