Because you joined our 'AI in Auditing' webinar, we want to help you take the next step.
In the webinar, you discovered how Artificial Intelligence can support every stage of the audit process, from preparation to execution and reporting, and where it is crucial to stay cautious. You saw how AI can help streamline audit preparation, manage non-conformances, and assist with report writing, while human judgment remains indispensable.
Now it is time to transform these insights into concrete actions for your organization.
On this page, we have gathered a complete overview of the company-level training and services we offer within auditing, compliance, and inspection readiness. Each of them is designed to strengthen your teams, reduce risk, and help you move confidently towards full compliance.
Explore our offerings below and see how we can support your company on the journey from insight to implementation.
Build deep auditing capabilities in your organization with this high-end course, tailored specifically to your company’s needs and SOPs. Over 1–3 days, your teams will gain the skills, structure, and confidence to plan and execute audits to the highest industry standards, based on ISO 19011 and GMP guidelines (EU GMP, 21 CFR). The training combines theory, practical exercises, and role-play simulations to create lasting competence development.
Your team will learn how to:
• Plan, conduct, report, and follow up on audits effectively
• Apply ISO 19011 principles within a GMP/PQS framework
• Understand regulatory expectations and risk-based audit planning
• Communicate effectively and manage conflicts during audits
• Evaluate and categorize audit findings
• Write comprehensive and professional audit reports
• Use AI and other tools in the different audit stages
• Audit Principles and ISO 19011 Framework
• GMP and Pharmaceutical Quality Systems
• Supplier and Contract Manufacturer Audits
• Audit Planning, Team Roles, and Document Review
• Communication, Interviewing, and Conflict Management Skills
• Risk-Based Audit Planning and Categorization of Findings
• International Supplier Audits and Cultural Considerations
• Report Writing and Post-Audit Follow-Up
Quality Assurance professionals, Qualified Persons (QPs), Regulatory Inspectors, self-inspectors, and others involved in supplier or internal audits within the pharmaceutical or medical device sectors.
At least one year of professional experience in the pharmaceutical or medical device industry, with foundational knowledge of GMP (EU/US) and GDP. Completion of an intermediate QMS/GMP/GDP course is recommended.
Stay ahead of evolving regulations and authority expectations with this advanced company training. Your teams will get up to speed on the latest developments, trends, and focus areas within GMP — ensuring your quality systems and inspection readiness strategies are fully aligned with what regulators expect right now.
• EU regulatory updates: Annex 1 implementation, Annex 11 draft (data integrity & computerized systems), CCS expectations, EMA Q&As
• FDA trends: Top 483 citations, validation enforcement, CMO oversight, and the QMM program
• ICH & PIC/S news: Analytical lifecycle (ICH Q14, USP <1220>), and global harmonization initiatives
• Authority inspection focus areas: MHRA, Danish Medicines Agency and US Food and Drug Administration warning letter insights
• Current risks and pitfalls: Remote batch certification, change control, deviations, data integrity
Your team will learn how to:
• Get up to speed with current GMP regulations (EU/FDA/ICH/PIC/S)
• Understand what authorities are focusing on now
• Identify trends that may impact inspections and QMS
• Strengthen compliance strategies for 2025
GMP professionals in QA, QC, Regulatory Affairs, Manufacturing, Validation, and Inspection Readiness.
This foundational course gives your company a shared understanding of GMP fundamentals and how to apply them in daily operations. It builds a strong baseline for new employees or teams transitioning into regulated environments, ensuring they work compliantly and confidently from day one.
• History of GMP: Patient safety, historical context, and the evolution of regulatory frameworks
• GMP Fundamentals: Key principles of GMP in practice and their application in pharmaceutical operations
• Investigations & Change Control: Why deviation handling and change control systems are essential
• GMP Regulations Overview: EU and US requirements impacting pharmaceutical and API manufacturers
• Introduction to Validation: Key concepts in equipment qualification, process validation, and QC method validation
• Good Documentation Practice (GDocP) & Data Integrity: Accurate records and compliance expectations for trustworthy data
• Authority Inspections: What to expect during regulatory audits and how to respond effectively
Your team will learn how to:
• Understand and define key GMP concepts and regulations
• Explain the importance of validation, documentation, and data integrity
• Identify basic regulatory expectations from the EU and US frameworks
• Recognize what to expect from regulatory inspections
• Apply foundational GMP knowledge to ensure compliance and patient safety
New employees in regulated environments (QA, production, R&D, QC, supply chain), professionals transitioning into GMP-regulated roles, and service providers working with pharmaceutical manufacturers.
Beyond our structured courses, we also offer customized services designed to strengthen your company’s compliance culture, build internal auditing capabilities, and secure full inspection readiness.
These services can be delivered directly by our experienced specialists or structured as hands-on training for your teams — enabling them to carry out audits and prepare for inspections independently in the future.
• Internal audits – Our experts perform independent audits are performed by our experts to identify gaps, mitigate risk, and ensure your internal processes are fully compliant.
• Supplier audits – We assess your suppliers and contract manufacturers to confirm they meet regulatory expectations and support your quality standards.
• Mock inspections – Realistic simulations of authority inspections that reveal gaps and build confidence before the real inspection occurs.
• Inspection readiness assessments/gap analyses – Structured evaluations of your documentation, processes, and systems to pinpoint areas requiring improvement ahead of inspections.
• Tailored in-house auditing and inspection readiness training (2–3 days) – Practical, company-specific training where we develop your own auditors and inspection teams based on your SOPs, systems, and needs. These trainings are ready to be deployed and have been successfully delivered to companies such as ALK.
All services are tailored to your organization’s setup, challenges, and documentation, ensuring your teams not only understand what to do, but are fully equipped to do it themselves going forward.
At Epista, our trainers are recognized industry specialists with decades of experience in compliance, auditing, and inspection readiness. They combine deep regulatory knowledge with practical expertise to empower your teams to operate with confidence and pass inspections seamlessly.
We offer training in English, Danish, and Swedish.
If you want to explore how these trainings and services can support your company, reach out to us, and let’s discuss a tailored plan designed for your organization.