#HIVEBENCH FDA COMPLIANCE HOW TO#

Former President of Pacific Regional Chapter of Society of Quality Assurance. Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom includes training for Society of Quality Assurance.Д¬omments / collaborates with FDA on new guidance documents. Co-authored Computerized Systems in Clinical Research w/ FDA & DIA Patent on speeding up software compliance. Co-authored & prototyped 21 CFR 11 guidance with FDA. Eg can you indepently confirm the key results o Your scripts are software - the FDA requires evidence of a credible process in the life cycle of software, whether they be spreadsheets, real time control systems or whatever. Positions include Chief Compliance Officer,Director of QA and MIS Director. o Evaluate the risk and safety implications of the statistics you use. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers & Stanford Hospital. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services.Д®xperience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Future Trends in 21 CFR 11 compliance for Excel SpreadsheetsДЄngela Bazigos is the CEO of Touchstone Technologies Inc.

How does the FDA Design and Use spreadsheets.

Design Specifications for 21 CFR 11 compliance.

Consequently, validation of Excel Spreadsheet Applications is required as part of a 21 CFR 11 compliant environment. However, the FDA expects that spreadsheets be compliant and lack of compliance can result in a warning letter. Why should you attend: Spreadsheet Applications such as MS Excel are frequently used in 21 CFR 11 compliant environments, but they were not specifically designed for regulated environments and their development is not optimized for 21 CFR 11 compliance.

#HIVEBENCH FDA COMPLIANCE HOW TO#

It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application. This webinar will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations.

Hivebench fda compliance