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ISO 9001:2015 Transition Training

Course Overview:

This highly participative course begins with a high-level overview of the differences between ISO 9001:2015 and ISO 9001:2008. Practical workshops and case studies help students understand and apply the new requirements of the ISO 9001:2015 standard. Learn the steps to take now to ensure a successful transition to ISO 9001:2015. This course also includes "Ask the Assessor" where students can gain valuable insight into what lead assessors and auditors are looking for and get practical real-world advice, best practices, and tips.

Discussion Topics:

  • Overivew of ISO 9001:2015 Standard
  • Highlevel overview of the diffences between ISO 9001:2015 and ISO 9001:2008
  • Understanding the key elements and importance of a gap assessment
  • Transition Planning
  • Important QMS Updates
  • Ask the Assessor

Student Prerequisites:  Each student shall be required to have studied the most newly revised version of ISO/IEC 9001:2015 prior to attending the course.  Please bring a copy of the standard with you to the course.

QUESTION & ANSWER TIME - "ASK THE ASSESSOR"

  • Gain insight and best practice advice and tips

WHO SHOULD ATTEND

This course is acceptable for all staff who participate in the operation of the quality system.

Group(s): Training
Speaker: Gretchen McAuliffe
Speaker Gretchen 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 quality assurance support to ISO and GxP manufacturers, laboratories, and distributors.  As a QA professional, she ...

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 quality assurance 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 has extensive experience in quality management systems, technical writing, business process mapping, database requirements and implementation, document control, 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), Certified HACCP Auditor (CHA).  She is also one of the first GMP professionals in the world to be certified to ASQ Certified Pharmaceutical GMP Professionals (CPGP) criteria.  She is also a certified ISO 9001:2000 lead auditor. She has received training in Good Laboratory Practices, Good Manufacturing Practices and International Pharmaceutical Excipient Council Good Manufacturing Practices for Excipients.  In addition, Gretchen is a trained Administrator for ThermoFisher Scientific’s SampleManager LIMS.



Gretchen has provided support to companies who must comply with good manufacturing practices (GMPs), good laboratory practices (GLPs), good clinical practices (GCPs), ISO 9001:2008, ISO 17025:2005, ISO 22000 and Safe Quality Foods (SQF).  



When she finds time to relax, Gretchen enjoys spending time with her husband Shannon McAuliffe and their two daughters, Caitlin & Ciara.  She enjoys traveling, a good book and a dinner with family and friends.


 

Full Description
Organizer Labtopia Training

At Labtopia Training, we are scientific and technical professionals just like you. Therefore, we understand the unique challenges you face in your workplace.  With over 25 years of industry experience, we understand the importance of consistent, effective training programs.

When?

Thu, April 27, 2017
8:30 a.m. - 4:30 p.m.
(GMT-0500) US/Central

Event has ended

Where?

Labtopia Classroom
12929 Gulf Freeway, Suite 108
Houston, TX 77034
United States of America