GXP Compliance

Are you looking to strengthen your organization’s GxP compliance culture and inspection readiness?

We provide professional, industry-focused training programs for:

• GMP (Good Manufacturing Practice)
• GCP (Good Clinical Practice)
• GLP (Good Laboratory Practice)
• GDP (Good Documentation Practice)

Training sessions are available:

• On-site across North America
• Virtually via Zoom for global teams

With extensive experience in regulatory affairs, clinical research, quality systems, medical writing, and submissions to global health authorities, we tailor each session to the specific needs of biotech, pharmaceutical, radiopharmaceutical, medical device, and healthcare organizations.

Training topics may include:

• GxP fundamentals and compliance expectations
• Data integrity and ALCOA+ principles
• Inspection and audit readiness
• Documentation best practices
• Deviation, CAPA, and quality systems
• Regulatory expectations from FDA, EMA, Health Canada, and ICH

Whether you are onboarding new staff, preparing for inspections, or strengthening quality culture, customized training solutions are available for your teams.

Feel free to connect or message us to discuss your organization’s training needs.