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Electronic Records Management

July 16, 2021: 11:00 - 3:00 pm EDT

Webinar


Course Description:

Records play a big part in determining the quality and usefulness of the data, both hard copy and electronic. This class focuses on how electronic records might be used. With many labs moving to the use of electronic records, it becomes important to understand how these are handled.

The objective of this class is to provide guidance in meeting TNI’s 2016 standard (EL-V1M2-2016- Rev 2.1: Quality Systems General Requirements Sections 4.13 Control of Records; 4.16 Data Integrity, 5.5-5.10 traceability, collection, handling, testing and reporting of results).  This would also include ideas for how to locate state requirements.

Expected Learning Outcomes:

  • Understanding TNI requirements for an electronic record, storage requirements, maintenance and disposal, retrievability, confidentiality, protection, and back-up with an emphasis on how electronic record keeping can be used.
  • Audit trails, traceability, records of observations, calculations, tracking changes/corrections to include signage of who made the changes provide the guidelines to meet the standard requirements. 
  • Raw Data management/association- how can the raw data be kept and associated and easily accessible.
  • Electronic security, software documentation and verification- establish the requirements and processes to demonstrate adequate documentation.
  • Electronic QC records- what types of information can be attained?
  • Where can I locate state requirement information?

Intended Audience:

This course is designed for Laboratory management (Laboratory Director/Technical Manager/Quality Assurance Manager), supervisors, and key laboratory staff.

Cost:

$95 per person for TNI members
$110 per person for TNI non-members
$450 per group of 5-10 students at same location for TNI members
$525 per group of 5-10 students at same location for TNI non-members

 


No certificates are automatically provided with this training. A Certificate of Completion (CoC) ($30 per person) or Certificate of Attendance (CoA) ($20 per person) may be purchased during or after registration or webcast purchase. A passing score of at least 70% must be received on the exam in order to receive CEUs and a CoC. Scores of less than 70% will receive a Certificate of Attendance at no reduced fee. For a CoA you will not need to take the quiz and you will not receive CEUs. To receive your certificate, contact Paul Junio at [email protected] with date of purchase and date of training completion. See FAQs for additional information.

Format:
Webinar

Start Date:
Friday 16th July 2021, 11:00am EDT

Length:
4 hours

CEUs: 0.4

Presented By:


Tony Francis

About the Presenter:

Tony Francis received his PhD in chemistry from the University of Utah followed by a post-doctoral appointment at Los Alamos National Laboratory. He then owned and operated a commercial laboratory in Las Vegas, NV for many years. Dr. Francis has taught several introductory and advanced biology and chemistry at Salt Lake Community College, the University of Utah, the University of New Mexico, the College of Southern Nevada, and Utah Valley University. He has delivered many Data Integrity and Ethics training courses to laboratories across the United States. He has created and delivered many online training webinars covering many aspects of quality systems, most recently for IAS.Tony is currently the Lead Assessor for SAW Environmental performing 40+ assessments per year for TCEQ, FDOH, IAS, and A2LA.