Certified GMP Auditor

The Certified GMP Auditor (Pharmaceutical & Medical Devices)

Current GMP (Good Manufacturing Practice) legislation requires that there are internal and external audit programmes operating as part of an integrated quality system. GMP regulations mandate training of all personnel including technical, engineering, and administrative personnel who perform duties in manufacturing, processing, packing, storage, quality control/assurance departments and whose functions could affect the quality of the product. Auditing is a significant function within a pharmaceutical industry. It provides management with information about how effectively an organization operates and controls the quality of their processes and products. Effective auditing should provide evidence of operational and statutory compliance status and identify opportunities for continual improvement and improved supply chain control and relationships. This course is specifically designed to address the challenges of GMP auditing for the pharmaceutical industry and present the basic competencies required to effectively perform the auditor's designated responsibilities and contribute to the improvement of auditor performance that includes understanding of audit techniques, audit activities that complements quality and risk management processes to ensure business compliance and identify quality improvements.

Key Outcomes:

• Understand key techniques and thought processes which can be used by auditors to implement the comprehensive audit program based on PERC Technique, i.e. Planning, Execution, Reporting and Close-out.
• Understand and perform audits as per the requirements of ISO 19011.
• Understand how to maximize the benefits of each stage of audit. These include planning and preparation, structuring the audit, managing the audit team, classifying observations, close out and reporting, corrective actions, and preventive actions and follow up.
• Understand audit requirements for Manufacturing operations, Contract manufacturing organizations, API suppliers, Excipient suppliers, Packing component suppliers, Service providers.
• Understand how different departments function together with projecting quality, safety, and efficacy of the pharmaceutical products as a cross-functional responsibility.
• Understand fundamental requirements and consequences of noncompliance of regulatory agency governance, including global regulatory framework, relevant regulations and guidelines, and mutual recognition agreements.

Course Chapters:

• Chapter 1- Introduction to Course
• Chapter 2- Introduction to Good Manufacturing
• Chapter 3- Preparation for Audits
• Chapter 4- Inspection of Quality Systems
• Chapter 5- Biotechnology and Medical Device Inspection Guide
• Chapter 6- Drugs Inspection Guide
• Chapter 7- Computerised Systems Inspection Guide
• Chapter 8- Guidelines For Auditing Management Systems

Pharmaceutical Certified GMP Auditor etraining online course