Pharmaceutical and device manufacturers must implement proper procedures for electronic data maintenance in order to avoid expensive and burdensome enforcement actions by the FDA.
Durham, NC (PRWEB)
August 09, 2017
AudioEducator, a division of audio conference and corporate education leader ProEdTech, will host the live webinar “Excel Spreadsheets: Develop and Validate for 21 CFR Part 11 Compliance” with industry veteran Dr. David Lim on Wednesday, August 23, 2017 at 1:00 pm ET. This session will provide tips to assist manufacturers of drugs, biologics, biosimilars and medical devices in developing and auditing Excel spreadsheets for 21 CFR Part 11 compliance.
Under 21 CFR Part 11, the FDA’s main regulation of electronic records and signatures, drug and device manufacturers must validate the computer software they use in their quality control systems in order to ensure the accuracy and confidentiality of electronic data they’re required to maintain. Using Excel is one of the main ways that firms maintain that data. As part of their compliance efforts, pharmaceutical and device manufacturers must check current practices and implement proper procedures in this key risk area in order to avoid expensive and burdensome enforcement actions by the FDA.
In this session, expert speaker Dr. David Lim, Ph.D., RAC, ASQ-CQA, will explain how to develop and implement Part 11 and Excel spreadsheet computer system validation. Providing practical advice and examples, David will discuss all applicable definitions and compliance requirements for Excel spreadsheets under 21 CFR Part 11 and other federal statutes and regulations. He will specifically cover how to maintain this data for the purposes of good practices (GxP) compliance.
This session will help pharmaceutical and device company CEOs, VPs, compliance officers and other healthcare professionals learn about:
Compliance requirements for Excel spreadsheets under 21 CFR Part 11
- Other applicable statutes and regulations
- Excel spreadsheets for GxP data
- Protecting Excel spreadsheets
- FDA enforcement actions relating to Excel spreadsheet maintenance
- How to avoid FDA 483s and warning letters
- Excel and computer system validations
- Excel data…