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GMP Auditing Online Course Demo
GMP Auditing Online Course Demo
GMP Auditing Online Course Demo
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.

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.
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.

Instructor Biographies

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. 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 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.

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. He joined the TGA in 1971 as a GMP inspector, after having worked in the pharmaceutical industry for six years in a senior Quality Assurance position. While at TGA he was elected Chairman of PIC/S in 2000-2001. After retiring from TGA in August 2004 and establishing “Bob Tribe Consulting”, he has assisted many GMP regulatory authorities around the world reach the PIC/S level of regulatory control. Of the twelve regulatory authorities that he has assisted to date, six have obtained PIC/S membership. He also consults to pharmaceutical manufacturers wishing to achieve compliance with PIC/S GMP requirements.He 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.
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CEU's Offered: No CEU's are awarded for this Demo Course

*Note*: 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.

Member Price: $ 0.00 /
Non Member Price: $ 0.00 /
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