Electronic Records Management
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.Fees:
$95 for TNI members
$110 for non-members
Group rates are available: Each purchased webcast is to be viewed by only one student. If you would like multiple viewers, separate purchases must be made. A group rate of $450 for TNI members or $525 for non-members is available for groups of 5 or more students at a single location. Click here to purchase this webcast at the group rate.
TNI Members: you must be logged-in to the website to receive the member rate.
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 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 Suzanne Rachmaninoff at email@example.com with date of purchase and date of training completion. See FAQs for additional information.
About Webcasts: Upon receipt of your payment, you will receive a special link by e-mail to watch the webcast on your computer. The link is time-limited: you will have full access to the webcast and any associated handouts for 6 months after receipt of payment, at which time the link will expire. Webcasts cannot be downloaded; they are intended for viewing on your computer only during the 6-month window. If you have any questions, please contact Ilona Taunton at firstname.lastname@example.org.
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.