Auditing for GMP

ISPE CEUs*: 1.2 Type: Classroom Training Course

Description

Auditing is a critical function of a pharmaceutical company. It provides management with information about how effectively a company controls the quality of their processes and products. Auditors must perform their jobs competently to ensure their company’s compliance with pharmaceutical GMP regulations and other quality standards. This course provides information to increase an auditor’s ability to audit in a professional and knowledgeable fashion using a wide variety of hands-on activities and teaching methods. This course will contribute to the improvement of auditor performance within a regulated industry.

Auditing for GMP 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 assigned responsibilities. Participants will learn how to prepare for more effective audits, conduct audits, formulate and ask good questions, properly evaluate and report audit findings and provide recommendations for corrective actions. Other topics addressed in this course are auditor roles and skills as well as GMP basics. Practical application of auditing techniques and GMP knowledge will also occur.

Take Back to Your Job

• Identify the critical competencies needed to be a conscientious auditor
• Understand the concepts behind compliance auditing
• Prepare to perform an audit
• Conduct an audit using an audit trail and checklist
• Effectively evaluate audit and report findings and involve management in follow-up activities
• Identify critical components to a good audit report 
• Increased knowledge of cGMP concepts and regulatory requirements
  

Attendance Suggested For

• Professionals who are responsible for conducting internal or vendor GMP audits
• Suppliers and others who are audited, such as quality assurance and quality control specialists, validation scientists, manufacturing supervisors, technical support personnel, engineers, and all levels of management

Continuing Education Units

ISPE will provide continuing education units (ISPE CEUs) for all North American seminars and courses, including educational programming at the ISPE Annual Meeting. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.

Delegates attending European seminars and courses will receive a Certificate of Attendance, as ISPE CEUs are currently not offered at European events. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be mailed within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.