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.
In this webinar you will learn:
- Strategies for how to document and validate Access databases and other software applications based on databases.
- How to add audit trails to databases and spreadsheets
- How to define requirements quickly.
- Managing change control and common change control mistakes to avoid.
- How to document inputs, code and security settings.
- How to properly secure the data and code.
- Access security settings for multiple users.
- Common settings applied to limit user actions.
- Details on when and where to use electronic signatures.
- Advanced techniques for adding electronic signatures
- Inactivity timeouts, and controls for users and passwords.
- Tips for efficient database testing.
- Learn about how the FDA secures their own databases and spreadsheets
Instructor: Tyson M. Mew
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, audioconferences 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 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.
Fee: $345 per person. Call for special per person pricing for multiple participants from your company.
