GxP: Manufacturing & Processes

Design efficient stability studies that are suitable for global marketing. Be able to carry out appropriate stability studies and manage stability samples and facilities, learn how to save resources on stability testing and improve the likelihood of regulatory approval of stability protocols.

A focused course on modern, lifecycle-based process validation and qualification. Learn how to design, qualify, and maintain manufacturing processes in a state of control using science- and risk-based approaches aligned with FDA, EU GMP Annex 15, MHRA, and WHO expectations - supporting compliant, efficient, right-first-time validation.

A practical, regulator-aligned course on pharmaceutical technology transfer, covering science- and risk-based methods, QbD, QRM, digitalization, and analytical method transfer to ensure compliant, reliable product supply.

Master the principles of cleaning validation to ensure pharmaceutical manufacturing equipment meets stringent regulatory standards, preventing contamination and safeguarding public health.

This course covers technology transfer for solid dosage forms, focusing on best practices, strategies, and real-world challenges through interactive sessions and case studies.

Vaccinology continues to advance and mature impressively, both in developing new and improved vaccines and in administering vaccines to prevent disease. On this course, explore GMP principles in vaccine manufacturing.

A two-day course on applying Statistical Process Control to monitor manufacturing processes and meet regulatory expectations from the U.S. Food and Drug Administration, European Medicines Agency, and World Health Organization.

A two-day course on planning and delivering GMP-compliant pharmaceutical facilities, covering project scope, scheduling, risk management, and regulatory readiness.