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Overview of NELAP Requirements - TNI 2009

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Overview:

This course will provide an overview of the Management and Technical requirements as stated in the TNI 2009 Volume 1 Module 2 Standard.  In addition, the overview will include Module 4 (Chemistry) and Module 5 (Microbiology) requirements.  The TNI 2009 standard is based on ISO 17025:2005.  This highly participative course includes interactive discussion on management and technical requirements as viewed from an assessor point of view.  This overview will include information on the quality manual, quality procedures, management requirements, technical records and developing technical standard operating procedures.  

Key Course Topics:

  • TNI 2009 Volume 1 Module 2 - Management & Technical Requirements 
  • Module 4 - Chemistry 
  • Module 5 - Microbiology
  • Quality Manual Requirements
  • Quality Procedures
  • Technical Records 
  • Development of Technical SOPs

WHO SHOULD ATTEND:

Managers or Laboratory Personnel who are required to work under NELAP Requirements. This course applyies to both new ventures and laboratories already meeting the standard.

ADDITIONAL COURSE INFORMATION:

Each attendee will receive a student guide containing a representation of the program’s slides and graphics with space provided for note taking.

Certificates of completion are provided to each attendee for the number of hours completed.

Group(s): Corporate
Speaker: Jeanne' Mensingh
Speaker Jeanne' Mensingh
Jeanné Mensingh is one of the co-founders of Labtopia.  As a Principal, Jeanné oversees operations for Labtopia Informatix and is Senior Consultant for Labtopia Solutions, and Labtopia Training.  She is also a principle and co-founder of Labtopia Staffing.  Jeanné has extensive experience in regulated industries and laboratories.  As a subject ...

Jeanné Mensingh is one of the co-founders of Labtopia.  As a Principal, Jeanné oversees operations for Labtopia Informatix and is Senior Consultant for Labtopia Solutions, and Labtopia Training.  She is also a principle and co-founder of Labtopia Staffing.  Jeanné has extensive experience in regulated industries and laboratories.  As a subject matter expert (SME) she assists regulated laboratories in streamlining their processes, leaning their operations, and meeting any regulatory requirements with automated systems such as LIMS.  In addition she provides quality assurance support to manufacturers, laboratories, and distributors related to ISO, GxP, and Environmental requirements.  She has extensive experience in all aspects of laboratory operation from the analytical bench to QA management in the plant and commercial laboratory environment.  Her background in quality management systems, technical writing, project management, business process mapping, database requirements and implementation, document control, validation, and laboratory compliance support her clients in all aspects of quality and regulatory requirements.  Some of her certifications include Lean Manufacturing, IS0 9001, and NELAC Lead Assessor. 


Jeanné has an ACS Certified B.S. in Chemistry from Northeast Louisiana University (now University of Louisiana at Monroe) and post graduate work in Chemical Engineering at Louisiana Tech University.  She has a Masters Certificate in IS/IT Project Management from Villanova University. She is an American Society for Quality (ASQ) Certified Quality Auditor (CQA), Certified HACCP Auditor (CHA) and a Certified Software Quality Engineer (SQE).  She is also a certified ISO 9001:2000 lead auditor and a Lead Assessor for NELAC (TCEQ and LDEQ). She has received training in Good Laboratory Practices, Good Manufacturing Practices and International Pharmaceutical Excipient Council Good Manufacturing Practices for Excipients.


Jeanné has provided QA and LIMS support to companies who must comply with good manufacturing practices (GMPs), good laboratory practices (GLPs), EPA Drinking Water Regulations, ISO 9001:2008, ISO 17025:2005, and TNI 2009 standard.


When she finds time to relax, Jeanné enjoys spending time with her husband Paul Mensingh and their two sons, Gabriel and Christian.  As an extensive traveler, Jeanné still finds time for her hobbies as a pastel artist, avid book reader, and scrap-booker.


Read more about Jeanne’s qualifications and current projects. href="https://www.linkedin.com/profile/view?id=30387926&authType=NAME_SEARCH&authToken=G-Bw&locale=en_US&trk=tyah2&trkInfo=tarId%3A1415287451444%2Ctas%3Ajeanne%2Cidx%3A1-2-2"> title="LinkedIn.png" src="http://www.labtopiainc.com/files/139/" alt="LinkedIn.png" width="31" height="31" />

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?

Mon, Jan. 15 - Tue, Jan. 16, 2018
8:30 a.m. - 4:30 p.m.
(GMT-0600) US/Central

How Much?

  • Overview of NELAP - TNI 2009 -  $895.00
    (ends 01/14/2019)

Where?

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