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 cGMP Internal and Corporate Auditor Training

Supply chain reliability is a basic business tenet. Supply chain assurance ensures reliability through a risk-based assessment of suppliers and vendors in the context of the product / service to be provided.  Auditors are often permitted   little time to conduct such audits therefore must be adept at applying risk-based audit strategies.  And internal company auditors (corporate auditors) have the unique responsibility of carrying out risk-based audits of sites within the company network.  This course is designed to help the pharmaceutical auditor conduct a risk-based audit and focus on what matters most from a regulatory compliance, patient safety, and business risk standpoint. The course is structured as a two-day program and can be customized building on technical topics depending on the client’s needs and 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.