Current good manufacturing practices (cGMP) extend well beyond product development and SOP monitoring — everything from facility design to unit strength and component purity plays a role. This 3-hour certificate program builds a robust understanding of how the quality of active pharmaceutical ingredients and finished products is assured, and how regulators in three major regions inspect for it.

The course compares the status of GMP harmonization and future trends across the U.S., EU, and Japan, and examines where inconsistencies arise among WHO, ICH, and individual countries. It reviews key ICH chapters and how regulators from the three regions assess and enforce compliance with ICH Q7, including how inspections can differ from a single ICH standard.

Sessions cover auditing API and finished-product facilities (typical audit agendas and regional differences), plus excipients, sterile products, biologics, and clinical packaging. The program also addresses regional differences in how GMP inspections are conducted, outsourcing management (contract manufacturing, packaging, and third-party testing), and how to focus internal and pre-audits on a combined US, EU, and Japan compliance system.

Agenda at a glance:

• Session 1 — U.S., EU, and Japan GMPs: status of harmonization, future trends, where inconsistencies become a problem (WHO, ICH, countries), key chapter reviews, and compliance with ICH guidelines.
• Session 2 — Auditing APIs and finished products (typical agendas, ICH area differences), plus excipients, sterile products, biologics, and clinical packaging.
• Session 3 — Area GMP inspections and focus differences, outsourcing management (contract manufacturing, packaging, third-party testing), and auditing your facilities for global considerations.

After this webinar, attendees will be able to answer -

• How do GMP requirements and inspections differ across FDA, EMA, and PMDA, and where are they harmonizing?
• Where do WHO, ICH, and country-level expectations diverge, and why does that matter for inspections?
• How do regulators from the three regions assess and enforce compliance with ICH Q7?
• What does a typical audit agenda look like for API versus finished-product facilities?
• How should self-inspection systems be modified to address customized regional concerns?
• How can pre-audits and internal audits be focused on a combined US, EU, and Japan compliance system?

This webinar benefits the following agencies -

This session is built around the GMP frameworks and inspection practices of the U.S. FDA, the European EMA, and Japan’s PMDA, and references ICH Q7 and broader ICH guidelines. It is relevant to organizations whose products are inspected across these three regions.

Who should attend?

cGMP training is suitable for professionals across all functions of a manufacturing unit, including:

• R&D Associates and Research Scholars
• IT Subject Matter Experts
• Contract Laboratory personnel
• Regulatory Affairs personnel
• Senior Management