Auditing is a critical function within a pharmaceutical company. It provides management with information about how effectively the company controls the quality of their processes and products. Auditors must perform their jobs competently to ensure their company’s compliance with pharmaceutical USFDA GMP regulations and other quality standards like ICH Q10. 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 and contribute to the improvement of auditor performance within a regulated industry. This online course includes a supplemental module that provides guidance in preparing for regulatory GMP inspections and is designed to provide broad fundamental industry knowledge through a customized learning experience for individuals that want to expand their cGMP knowledge.
Course Modules/Learning Objectives
- Module 1: Introduction to auditing and Audit preparation
- Define an audit and explain why audits are carried out
- Discuss types and levels of audits
- Discuss preparation for an audit
- Module 2: Attributes and experiences of a good auditor
- Explore auditor traits and skills
- Describe strategies for asking questions
- Describe good listening skills
- Review the importance of body language on the audit process
- Module 3: Steps and activities for successful audits
- Review the Audit Timetable
- Provide guidelines for Conducting the Audit
- Discuss the importance of records and note taking
- Provide auditing tips and resources for auditors
- Module 4: Post-audit activities and follow-up
- Provide guidance for Exit Meeting preparation
- Explore managing your findings
- Explore attributes and considerations of a good report
- Review follow-up activities and problem solving tools
- Module 5: Inspection points to consider during an audit
- Review inspection points to consider in auditing
- Module 6: Interesting points often missed
- Gain awareness of points that may be missed during an inspection
- Module 7 (Supplemental): Preparing for Regulatory GMP Inspections
- Preparing to host a regulatory GMP inspection
- Preparing for activities during the inspection
- Preparing for activities after the inspection
**This module is based on PIC/S inspection, but the principles are applicable to other inspections or audits.
- Individuals with two to three years of direct experience working with the USFDA and PIC/S GMP guidelines who want to develop additional expertise in GMP Auditing.
- New auditors or individuals wanting to become auditors.
- 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.
Community of Practice (COP): This training course is of particular interest to existing and future members of the ISPE Process/Product Development (PPD) Community of Practice (COP).
Jeri Weigand is currently a clinical quality auditor, working for the Medtronic Clinical Research Institute, Medtronic, Inc. in Fridley, Minnesota. Prior to this role, she was a corporate quality system auditor at Medtronic, auditing internal and external manufacturing and lab sites in the US and globally.
Robert Tribe joined ISPE in August 2004 as the Regulatory Affairs Advisor for the Asia-Pacific region. Prior to this he was the Chief GMP Auditor for the Therapeutic Goods Administration (TGA), Australia, a position he held for 23 years.