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ISO 9001/ISO 17025 Internal Auditor Training


This highly participative course provides comprehensive instruction on auditing quality management systems based on the ISO 9001 requirements. The training will teach process based audit skills useful in internal and external audits. Practical workshops, case studies, and simulated assessments are used to practice auditing skills and techniques. Reference is made to the international standards on quality management systems. The first 1.5 days of class will focus on audit principles and common requirements of the ISO 9000 and ISO/IEC 17025 series. Participants may also choose to register for the additional half day session which will focus on unique audit requirements for ISO/IEC 17025 quality management systems.

Key Session Topics:

  • Coordinating a quality management system audit
  • Constructing an audit program and the preparation of audit checklists
  • Learning effective auditing techniques
  • Preparing nonconformity statements
  • Evaluating the significance of audit findings
  • Methods for improving communication skills
  • How to report audit findings and conclusions
  • Developing and implementing corrective action programs
  • Evaluating corrective action responses
  • How to effectively follow-up audit findings to recognize if the nonconforming situation has been effectively resolved

Prerequisites:

 Each student shall be required to have studied the current published version of ISO 9001 and/or ISO/IEC 17025 prior to attending the course. Please bring a copy of the standard with you to the course.

Group(s): Training
Speaker Gretchen L. McAuliffe
Gretchen McAuliffe is one of the co-founders of Labtopia.  As a Principal, Gretchen oversees operations for Labtopia Staffing and is Senior Consultant for Labtopia Solutions, Labtopia Training and Labtopia Informatix.  Gretchen specializes in providing a wide range of quality support to ISO and GxP manufacturers, laboratories, and distributors.  As a ...

Gretchen McAuliffe is one of the co-founders of Labtopia.  As a Principal, Gretchen oversees operations


for Labtopia Staffing and is Senior Consultant for Labtopia Solutions, Labtopia Training and Labtopia


Informatix.  Gretchen specializes in providing a wide range of quality support to ISO and GxP manufacturers,


laboratories, and distributors.  As a QA professional, she is an expert in developing integrated systems


for regulated industries.  She also has extensive experience in technical writing, business process mapping and


laboratory compliance.  During her career, she has managed and conducted domestic and international


audits of manufacturers, distributors and laboratories. 


 


Gretchen has a B.S. in Biology from the University of Houston and a M.S. in Biological Sciences from the


University of Houston-Clear Lake. She is an American Society for Quality (ASQ) Certified Quality Auditor


(CQA), Certified Biomedical Auditor (CBA) and a Certified HACCP Auditor (CHA).  She is also one of the first


GMP professionals in the world to become a ASQ Certified Pharmaceutical GMP Professional (CPGP). 


In addition, Gretchen is a is also a certified ISO 9001:2008 lead auditor and trained Administrator for


ThermoFisher Scientific’s SampleManager LIMS.


 


When she finds time to relax, Gretchen enjoys spending time with her husband Shannon and


their two daughters, Caitlin & Ciara.  She enjoys traveling, a good book and a dinner with family and


friends.

Full Description
Organizer Jhana K. Porter


Addons

T-Shirt

Price$20.00
Options small, medium, large

When?

Tue, Dec. 3 - Wed, Dec. 4, 2013
8 a.m. - 5 p.m.
(GMT-0500) America/Chicago

Event has ended

Where?

Labtopia, Inc.
12929 Gulf Freeway, Suite 108
Houston, TX 77034