2013 Prague October Training2013 Prague October Training2013 Prague October Training

GMP Auditing for the Pharmaceutical Industry (G07)

Level: Fundamental
ISPE CEUs: 1.3
Type: Classroom Training Course

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17 - 18 Nov 2016 Tampa, FL USA Mr. Thomas J. Ofsharick


This course is also available as an online training course. GMP Auditing for the Pharmaceutical Industry. Try Module 1 for free!

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.

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

For Medical Device Auditing, please refer to the ISPE online Training Auditing for Medical Devices. Demo the Auditing for Medical Devices Course Now!

Course Modules

  • Background Information
  • Auditing Department Basics
    • Exercise: Be, Know, Do
  • Traits/Skills of a Good Auditor
    • Group discussion: Fishbone Diagram
    • Group discussion: Exercise: Potential Interview Problems
    • Group work: Exercise: Getting it Right
  • GMP Background Information for Auditors
    • Exercise: Home Base Worksheet
    • Exercise: Preamble Activity
  • Pre-Audit Information
  • Conducting the Audit
    • Group work: Common Items to look for in an Audit
  • Post Audit
    • Group work: Classifying, Managing, Justifying your findings
    • Exercise: cGMP Compliance
    • Exercise: Ranking – GMP Observations
    • Group work: Root Cause Analysis 5 Why’s
    • Group work: Root Cause Analysis From Fishbone
  • Additional Resources and Worksheets/Checklists
    • Calibration, Equipment and Validation Information
    • Audit Strategies
    • Additional Considerations for GMP Auditing
    • Audit Report Example 1,  Example 2,  Example 3

Take Back to Your Job

  • Prepare and conduct audits using an audit trail and checklists
  • Effectively evaluate audit and report findings
  • Identify critical components for a good audit report
  • Conduct an audit using an audit trail and checklist
  • Understand the concepts behind compliance auditing
  • Increased knowledge of cGMP concepts and regulatory requirements related to auditing
  • Identify the critical competencies needed to be a conscientious auditor

Attendance Suggested For

  • This course is recommended 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

Community of Practice (COP)

This training course is of particular interest to existing and future members of the ISPE Process/Product Development (COP).

Continuing Education Units 

ISPE will provide continuing education units (ISPE CEUs) for all North American and European courses. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be available for download in your ISPE account within four weeks of the completion of training. Instruction for download will be sent when the CEUs are available. One hour of education programming equals 0.1 ISPE CEU credits.

Indicates content available to ISPE members only.

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