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Achieving Quality and GLP Compliance in the Histopathology Laboratory

Recorded On: 10/15/2020

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You understand some of the basics of Good Laboratory Practices (GLP), but where do you start when it comes to ensuring your laboratory and all of your processes, including technical and general administrative, are compliant? A practical approach to GLP requirements and accepted methods for compliance in the histopathology laboratory will be presented in this lecture. The emphasis will be on identifying the specific regulations applicable to the histopathology laboratory with discussion on how to implement procedures that ensure both quality and compliance. Specific topics to be discussed include a brief history and overview of the GLP regulations concentrating on those most applicable to the histopathology laboratory. This includes personnel qualifications and training requirements, proper documentation of raw data and standard operating procedures (SOPs), accepted error corrections methods to raw data, QA functions, documentation of calibration and maintenance of equipment, reagent preparations, GLP requirements for the histopathology laboratory functions, and GLP-compliant methods for archiving study materials. Operational techniques and activities that help achieve quality and compliance will be discussed. Forms/records that can be used throughout the laboratory, including proper documentation at every step in a GLP compliant manner, will also be provided.

CEUs: This histology course is worth 1 continuing education credit. Course is available for 365 days from date of purchase. 

Elizabeth Chlipala, HTL(ASCP)QIHC

Owner Partner

Premier Lab

Elizabeth Chlipala is an owning partner, at Premier Laboratory, LLC, a contract histology laboratory in Longmont, Colorado, since 2003.  She has over thirty-seven years’ experience working in laboratories and hospitals, doing both clinical and research histology, immunohistochemistry and whole slide imaging.  She is a member of NSH, ASCP, CSH, and Colorado Bioscience Association.  She currently serves as Treasurer for the NSH and chair of the Digital Pathology Workgroup.

Elizabeth is an accomplished, knowledgeable and sought after speaker, speaking at over 80 conventions, symposiums, annual meetings and teleconferences, since 1986.  Her speaking engagements have included topics in histology, pathology, quality assurance immunohistochemistry and digital pathology.   Elizabeth has received numerous awards, including Illinois Society for Histotechnology – Technologist of the year (1993), National Society for Histotechnology – Dako Award for Excellence in Standardization of the IHC Techniques (2006), Biogenix Award for Standardization in Immunohistochemistry (2006) and the NSH Presidents Award (2019).


Elizabeth’s education includes a BS in Biology from Oakland University in Michigan and the William Beaumont Hospital School of Histotechnology for HTL(ASCP) and QIHC(ASCP) certifications.

Key:

Complete
Failed
Available
Locked
Achieving Quality and GLP Compliance in the Histopathology Laboratory
Open to view video.
Open to view video. Objectives: Identify subparts of the FDA 21 CFR Part 58 applicable to the histopathology laboratory; Apply the applicable subparts of the FDA 21 Part 58 to the histopathology laboratory; Implement operational techniques and activities that ensure quality and compliance in the histopathology laboratory
On Demand Webinar Survey
2 Questions
2 Questions Please complete the survey to receive your CEU certificate.
Certificate
1.00 CEUs credit  |  Certificate available
1.00 CEUs credit  |  Certificate available