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March 21 & 22, 2016 - Laboratory Controls in the GMP/GLP Environment

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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.

Key Session Topics:

  • Calibration programs
  • Analytical method validation
  • Equipment qualification
  • Control of standards and reagents
  • SOPs
  • Documentation practices
  • Outsourcing
  • Training programs
  • Change control

Advanced topics will also 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

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: 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.


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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, Mar. 21 - Tue, Mar. 22, 2016
8:30 a.m. - 4:30 p.m.
(GMT-0500) America/Chicago

Event has ended

Where?

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