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GMP Auditing for the Pharmaceutical Industry
GMP Auditing for the Pharmaceutical Industry
GMP Auditing for the Pharmaceutical Industry

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.

The 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.

Immediately apply the course learning objectives with pre and post assessments, downloadable course presentation for note taking, learning reviews highlighting important points, hot-links to regulatory and industry information, and an online resource handout as a quick reference for all web links discussed.

Approximate Course Duration: 2 Days (this is a self-paced course)

*NOTE* You will have 14 calendar days to access and complete this course from time of purchase. ?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
  • 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.


  • This module is based on PIC/S inspection, but the principles are applicable to other inspections or audits.

    Note: This course is not designed to prepare companies to be audited and does not contain content for medical device auditing.


    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.?

    Discounted member price: 546.00
    Your price: 637.00
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    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.

    The 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.

    Immediately apply the course learning objectives with pre and post assessments, downloadable course presentation for note taking, learning reviews highlighting important points, hot-links to regulatory and industry information, and an online resource handout as a quick reference for all web links discussed.

    Approximate Course Duration: 2 Days (this is a self-paced course)

    *NOTE* You will have 14 calendar days to access and complete this course from time of purchase. ?

    Member Price: $ 546.00 / € 546.00
    Non Member Price: $ 637.00 / € 637.00
    Item #: WEBTRAUDEU


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