The GxP Internal Audit Report: An Interpretation

Why Should You Attend:

The GxP IA is a potent, routine, systematic, independent process and product assessment, assurance and improvement tool. An independent IA report adds value by effectively communicating audit results to relevant stakeholders. However many audit reports are not actionable, failing to engage, communicate and persuade the stakeholders to action. All too often audit reports are simply records to demonstrate audit compliance. Failure to successfully interpret engagement results renders even the best IA meaningless.

Auditors need to be skilled observers as well as effective communicators. It’s not enough to be able conduct a perfect audit. An auditor needs to be able to communicate the results of their audit. This communication is an analysis and interpretation of the audit engagement and needs to evoke appreciation, affirmation and action in stakeholders. Without an effective audit report the assessment, assurance and improvement utility and value of an IA is drastically reduced.

This course will aid in the identification of key components of an effective IA report, understanding the process of organizing and presenting a written audit interpretation to diverse stakeholders and developing a follow-up process for monitoring corrective actions. Also covered are critical concepts of audit observations, risk assessment, and addressing multiple stakeholder needs.

Areas Covered in the Webinar:

• Adding value with audit report writing
• Audit report elements, structure, and style
• Required audit documents
• Observation components, cause and impact
• Audit report checklist
• Risk assessment
• Understanding your reader
• Writing quality
• Word and sentence and use
• Risk and the three lines of defense

Who Will Benefit:

The following professionals from the Pharmaceutical, Biotechnology, GxP, and Medical Devices Companies

• IA/QA professionals
• Senior Managers, Managers & Supervisors
• Process Owners
• Departmental Heads
• Quality System, QA, QC and Continuous Improvement Managers and Personnel
• Quality Consultants
• Regulatory and Compliance Managers
• Change Control/Documentation Staff

William D Fox
Quality Management Professional, Texas Biomedical Research Institute

William D Fox is a quality management professional with a background in clinical research and quality assurance. William’s experience includes scientific, administrative, and quality aspects of regulated (ISO, GCP, GLP, GMP) pharmaceutical development and manufacturing and spans the translational interface (T1; late preclinical, early clinical) with a focus on oncology drug development and emerging disease vaccine development in BSL 2, 3 & 4 environments. William also has experience developing quality management systems, documents and change control systems in GLP, GCP and GMP settings.

Topic Background:

The independent internal audit (IA) is the only proactive, routine, systematic, independent process and product tool for assessment, assurance and improvement that an organization possesses. It is a fundamental requirement in GxP regulated industries and represents the third line of defense in effective risk management and process control. A successful IA program adds value to an organization by providing a record, ‘translated’ by the writer, of the audit engagement, authenticating assurance, facilitating governance and verifying control of processes and products. It is also a source of data for trending analysis, risk based audit scheduling and the identification of emerging issues or successful practices. A successful IA report writer must be able to act as an interpreter and communicate audit results to identified stakeholders of varying backgrounds and inspire them to take action and affect the changes required. Effective IA communication needs to be accurate, objective, clear, concise, constructive, complete and timely to be relevant. It also needs to impact and persuade.

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