Electronic Records Management
July 16, 2021:
11:00 - 3:00 pm EDT
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?
This course is designed for Laboratory management (Laboratory Director/Technical Manager/Quality Assurance Manager), supervisors, and key laboratory staff.
$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 Attendance may be purchased for $20 per person during registration or webcast purchase. To receive your certificate, contact Suzanne Rachmaninoff at firstname.lastname@example.org with date of purchase and date of training completion. See FAQs for additional information.
Friday 16th July 2021, 11:00am EDT
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.