Many find 21 CFR Part 11 the FDA’s requirements for data safety and integrity, intimidating. This regulation provides the criteria under which electronic records and electronic signatures are considered trustworthy and reliable.
Electronic records aren’t just limited to documents – they can be records in a database such as electronic case report forms and audit trails.
- What if we capture data using a software application, but print out the results?
- What if we have an electronic record, but no electronic signature?
- Who ensures we are Part 11 compliant the vendor or my company?
- Why is the definition of raw data so important?
Please join the MN ASQ Biomedical Consortium in discussing this very thought-provoking topic with Carl McBurney.
Dates: Wednesday, July 26
Time: 6:00 pm – 8:00 pm CST
Location: St. Cloud State - Plymouth, 9750 Rockford Road, Plymouth MN
Cost:
· Minnesota ASQ & RAPS Members - $25.00
· Students – FREE when registering with student email and code BMC1
· Non-Members - $50.00
Certificates of Completion: Issued via email, after workshop completion, for .2 ASQ RUs or .2 CEUs.
A light snack will be provided
Instructor Bio:
Carl McBurney, M.S., Chemistry has been involved in the pharmaceutical and medical device manufacturing industry for 9 years in various quality roles. He is currently a Senior Development Quality Engineer at Abbott and the Membership Chair for the Minnesota section of ASQ. Carl has devoted a large portion of his career to developing and implementing documentation system solutions and ensuring data integrity compliance for benchtop and information management software.
Event Host
The MN ASQ Biomedical Consortium (BMC) are a group of quality professional promoting and advancing quality tools, principles, and practices through educational events. We focuses on medical device, pharmaceuticals, and contract manufacturing sectors, to name a few. ASQ Membership is not required to join. There are many ASQ perks provided when joining the BMC.
Consider becoming a member of one or both to enhance your professional experience.
· ASQ: https://www.asq.org/
· To become a member of the MN ASQ Biomedical Consortium, please email Karen Peifer at kdpeifer@memberleader.asq.org. This is a volunteer group where we meet to create learning opportunities for the community. With active participation, you can attend our events for free.