Auditing for GMP

Milan, 8-9 October 2008

Basic Level
ISPE CEU*s: 1.2
Type: Classroom Training Course

Instructor: Dr. Kate McCormick, Heathside Information Services Ltd (UK)

Description

Good Manufacturing Practice (GMP) requires good manufacturing auditors. Auditors must perform their jobs competently to ensure their company’s compliance with Pharmaceutical GMP regulations and other quality standards. Without qualified and well-trained auditors to evaluate performance, standards cannot be adequately reviewed, thus limiting performance improvement. 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 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 internal and vendor audits, formulate and ask good questions, properly evaluate and report audit findings, and provide recommendations for corrective actions.

Classroom Objectives

Identify the critical competencies needed to be a conscientious auditor
Understand the concepts behind compliance auditing
Evaluate information in order to anticipate and prevent problems, rather than correcting problems after they occur
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

Take Back to Your Job

Receive the training you need to improve your role as a GMP auditor
Address the challenges of auditing for the pharmaceutical industry and basic competencies required to effectively perform assigned responsibilities
Learn how to prepare for audits, conduct internal and vendor audits, formulate and ask good questions, properly evaluate and report audit findings, and provide recommendations for corrective actions

Attendance Suggested For

Professionals who are responsible for conducting internal or vendor GMP audits, such as quality assurance and quality control specialists, validation scientists, manufacturing supervisors, technical support personnel, engineers, and all levels of management. Also vendors and otherswho wish to understand the process in advance of being audited
This Training Course is of particular interest to existing and future members of the ISPE Process/ Product Development Community of Practice (COP)


Training Programme General Information Venue and Area Information Sponsorship Opportunities Registration Information Download Brochure Current as of 28 May	Auditing for GMP Milan, 8-9 October 2008 Basic Level ISPE CEUs: 1.2 Type: Classroom Training Course Instructor:* Dr. Kate McCormick, Heathside Information Services Ltd (UK) Description Good Manufacturing Practice (GMP) requires good manufacturing auditors. Auditors must perform their jobs competently to ensure their company’s compliance with Pharmaceutical GMP regulations and other quality standards. Without qualified and well-trained auditors to evaluate performance, standards cannot be adequately reviewed, thus limiting performance improvement. 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 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 internal and vendor audits, formulate and ask good questions, properly evaluate and report audit findings, and provide recommendations for corrective actions. Classroom Objectives Identify the critical competencies needed to be a conscientious auditor Understand the concepts behind compliance auditing Evaluate information in order to anticipate and prevent problems, rather than correcting problems after they occur 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 Take Back to Your Job Receive the training you need to improve your role as a GMP auditor Address the challenges of auditing for the pharmaceutical industry and basic competencies required to effectively perform assigned responsibilities Learn how to prepare for audits, conduct internal and vendor audits, formulate and ask good questions, properly evaluate and report audit findings, and provide recommendations for corrective actions Attendance Suggested For Professionals who are responsible for conducting internal or vendor GMP audits, such as quality assurance and quality control specialists, validation scientists, manufacturing supervisors, technical support personnel, engineers, and all levels of management. Also vendors and otherswho wish to understand the process in advance of being audited This Training Course is of particular interest to existing and future members of the ISPE Process/ Product Development Community of Practice (COP)