2013 Tampa Training, December 2014

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GMP Auditing for Quality Assurance Training Course

GMP Auditing for the Pharmaceutical Industry (G07)

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

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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).

SAVE hundreds of dollars on training by joining ISPE! Join now »

DatesLocationsInstructors 
13 Mar 2017 -
14 Mar 2017
Tampa, FL USA Speaker TBD
Register

Fees and Daily Schedule

TypeOn or Before
11 February
After
11 February
Member US$1,635 US$1,835
Nonmember US$2,020 US$2,220
Government US$900 US$1,010
Daily Schedule at a Glance
07.30 – 17.00 Registration Open
08.30 – 17.00 Training Course
10.00 – 10.30 Refreshment Break
12.00 – 13.00 Lunch
14.30 – 15.00 Refreshment Break
DatesLocationsInstructors 
06 Nov 2017 -
07 Nov 2017
Tampa, FL USA Speaker TBD
Register

Fees and Daily Schedule

TypeOn or Before
07 October
After
07 October
Member US$1,635 US$1,835
Nonmember US$2,020 US$2,220
Government US$900 US$1,010
Daily Schedule at a Glance
07.30 – 17.00 Registration Open
08.30 – 17.00 Training Course
10.00 – 10.30 Refreshment Break
12.00 – 13.00 Lunch
14.30 – 15.00 Refreshment Break

Group Discounts

  • 3 - 5 participants - Save 10%
  • 6 - 10 participants - Save 15%
  • 11 or more participants - Save 20%

To qualify, all registrant information must be submitted at the same time; only ONE payment to cover all registrations will be accepted. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105.

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