Each of these programs is delivered in an interactive format to engage the participants and ensure knowledge transfer and greater confidence with each topic. Contact us to learn more and obtain a course outline.

Pharmaceutical GMP Internal and Corporate Auditor Training

Auditing the pharmaceutical quality system (PQS) whether for drug products, biologics or combination products requires not only excellent knowledge of cGMP requirements but also fundamental understanding of the technologies, facilities, and quality management system frameworks. Auditors typically excel at checking off compliance requirements but often fail to assess risk and adapt their audit strategy accordingly. Furthermore, internal company auditors (corporate auditors) have the unique responsibility of carrying out audits within the company network where they may already have intimate knowledge. This course is designed to help the pharmaceutical auditor conduct a risk-based audit, focusing on what matters most from a regulatory compliance, patient safety, and business risk standpoint. The course is structured as a three-day program, follows Guidelines for Auditing Management Systems (ISO 19011), and can be customized to cover technical areas (steriles, biologics, combination products, etc.) depending on a client’s priorities.

Investigations and CAPA Training

Investigations and CAPA handling is probably the most frequently cited issue during regulatory inspections. Regulatory findings include reoccurring investigations, poor root cause analysis, absence of corrective action, poor timeliness, and an inadequate assessment of risk to quality and patient safety.  This course covers the standard elements of root cause analysis in the context of pharmaceutical operations, specifically aiming to address the weaknesses most commonly cited.  Topics include event triage, human performance improvement, and robust CAPA identification.  The course is structured as a two-day program and can be customized depending on prior training and current client priorities.

Quality Leadership, Quality Culture and Ethics

If your company has received the following notice from a regulatory authority – the “Quality Unit has failed to execute its authority and / or responsibilities”  – this course is intended to provide the Quality Unit and other managerial personnel with the perspective needed to work through the change in mindset required to properly address regulator’s concerns.  The course is based on the principles of ICH Q9 (Quality Risk Management and ICH Q10 (Pharmaceutical Quality Systems), reinforcing Quality Unit responsibilities, providing methodologies to embed a quality mindset and ethical behavior required to protect patients, ensure compliance, and reduce business risk.  The course is structured as an interactive two-day program and can be customized to build on existing training and specific company objectives.