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GMP Essentials for Laboratory Personnel


Overview:

What controls should laboratories implement in an FDA regulated environment? This training course provides a thorough review of GMP/GLP requirements and current industry practice for labs which support clinical trials as well as those who provide quality control testing for commercial products. The training includes information on science based management practices, such as:
  • Calibration programs
  • Analytical method validation
  • Equipment qualification
  • Control of standards and reagents
In addition, the course emphasizes laboratory quality system elements, as follows:
  • SOPs
  • Documentation practices,
  • Outsourcing,
  • Training programs, and
  • Change control
The speaker will also cover advanced topics which include out of specification (OOS) investigations, stability testing, and computer systems validation as it pertains to the laboratory.
As is apparent from the multitude of GMP warning letters related to laboratory compliance, laboratory controls is an area the FDA considers vital to drug product safety, quality, and efficacy. The laboratory plays a crucial role in the development and manufacture of drug products from the approval of submission documents to the release of the final product. Whether you work in paper based systems or electronic databases, this course will focus on effective ways to meet the requirements of the standards at any stage in the drug lifecycle.
Who Should Attend:
Managers or Personnel who are required to work in a GMP/GLP Environment.

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

When?

Tue, May 21, 2013
8 a.m. - 4 p.m.
(GMT-0500) America/Chicago

Event has ended

Where?

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