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 module is the first of our 7 module course and is now being offered as a free online course demo . It includes a pre-assessment to use as a learning tool to test your knowledge and understanding. You will need to purchase and complete the 7 module GMP Auditing course to receive ISPE CEUs and a completion certificate.
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.
Approximate Course Duration: 60 minutes (this is a self-paced course). You will have 5 calendar days to access and complete this course from time of purchase.
ISPE CEUs: .00 ISPE CEUs will be awarded upon successful completion of grading requirements
Attendance suggested for:
- 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.
Jeri L. 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. She previously spent thirty years working for 3M Pharmaceuticals in various capacities, most recently, working as an auditor for 3M Pharmaceuticals in St. Paul, MN, conducting audits in the area of Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and Good Manufacturing Practice (GMP). She is a Certified Quality Auditor through the American Society for Quality (ASQ) and a Certified Clinical Research Professional through the Society of Clinical Research Professionals (SOCRA). Weigand has also worked in the clinical trial materials arena and as a compliance coordinator in the areas of compliance monitoring, cGMP/SOP training, and development and implementation of a division-wide GMP training program, SOP system, calibration system, and laboratory glassware labeling system for the development and analytical groups of 3M Pharmaceuticals. Weigand is the founder and past chair of the Midwest Clinical Supply Discussion Group, past chair and member of the ISPE Clinical Materials Advisory Group, and current co-leader of the ISPE Training Advisory committee. She has been a workshop coordinator and leader for many national meetings and has co-authored a Pre-NDA Approval Inspection Checklist, a paper on Definitions and Controls for Labeling of Clinical Trial Materials and Clinical Supply Operations and the first edition of the Clinical Trial Materials Training Guide. Weigand has also authored a chapter on Training of Clinical Trial Material Personnel for the Second addition of the Drug Products in Clinical Trials. Weigand has a BS in education from Northwest Missouri State University, Maryville, MO and a Masters in Organizational Leadership from The College of St. Catherine, St. Paul, MN.
Bob Tribe joined the Therapeutic Goods Administration (TGA), Australia in 1971 as a GMP inspector after having worked in the pharmaceutical industry in a senior Quality Assurance position. He became Chief GMP Inspector in 1980, a position he held until his retirement in 2004. While at TGA he was elected Chairman of PIC/S in 2000-2001. After retiring from TGA he established “Bob Tribe Consulting” and has assisted many GMP regulatory authorities around the world reach the PIC/S level of regulatory control. Of the sixteen regulatory authorities that he has assisted to date, ten have obtained PIC/S membership. He also consults to pharmaceutical manufacturers wishing to achieve compliance with PIC/S GMP requirements. Bob is a member of the WHO Expert Committee on Specifications for Pharmaceutical Preparations and undertakes GMP inspections for the WHO under its Pre-qualification Programme. Bob is the ISPE Regulatory Affairs Advisor for the Asia-Pacific region.