The Executive Conference Corporation will present an e‑conference on 21 CFR Part 11 Compliance and Validation for Databases and Spreadsheets on December 17, 2009 from Noon to 1:30 pm ET. The e‑conference will be presented by Mr. Tyson Mew.
This conference has already occurred. Please contact Ofni Systems if you would be interested in setting up your own training session on 21 CFR Part 11 Compliance and Validation for databases and spreadsheets.
Hundreds of 483’s and warning letters are received each year by companies who did not design or validate their databases and spreadsheets to meet Part 11 requirements.
In this webinar you will learn how to implement Part 11 requirements in databases (Access, Oracle, and SQL Server) and Excel spreadsheets. This presentation will provide the instructions, and documentation to ensure full compliance with 21 CFR Part 11, including:
Tyson M. Mew is President of Ofni Systems, Inc., a software provider and Part 11 consulting firm. He has a strong background in software development and computer system validation, and has spoken at many conferences, webinars, audio conferences and workshops on FDA requirements for electronic records and signatures. Ty regularly conducts training sessions for organizations to educate employees about the specific requirements of 21 CFR Part 11 and Computer Systems Validation. He is an active member of ISPE, DIA, SQA and the Triangle PEERS group.
Ofni Systems is a leader in providing regulatory compliance solutions for pharmaceutical, biotech and medical device companies. They are the creators of ExcelSafe for Excel spreadsheet security and the Part 11 Toolkit for compliant databases. They also are the creators of the FastVal Validation Document Generator software for generating and executing validation documents, and have been providing professional validation services using FastVal since 2006.
Ofni Systems is also highly acclaimed for their expertise with 21 CFR Part 11 compliance. They are frequent speakers on Part 11 at conferences, meetings and webinars, and have provided training for thousands of employees to help implement the requirements. For more information, contact Ofni Systems at (919) 844-2494, via email at Info@OfniSystems.com, or by visiting www.OfniSystems.com.