Tyson Mew, president of Ofni Systems, will be at the 2013 PDA/FDA Joint Regulatory Conference in Washington DC on September 16-18, 2013. Ty will be demonstrating FastVal, Ofni Systems’ validation management system that provides validation managers with the unique ability to control their validation process. Using FastVal allows your validation engineers to do more testing while reducing the time required to complete a validation project by up to 70%. Ty will also be demonstrating ExcelSafe, which provides MS Excel spreadsheets with audit trails, individual user passwords and all of the technological controls required for compliance with 21 CFR 11 and other FDA regulations for electronic records and signatures.
The PDA/FDA Joint Regulatory Conference will provide FDA representatives and industry experts a forem to meet and discuss critical pharaceutical industry issues such as continual process validation, supplier management and quality oversite, supply chain and drug shortages and effective management of post inspection follow-ups. Parenteral Drug Association (PDA) is a global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical community.
Ty Mew and Ofni Systems will be available throughout the conference to discuss validation management, spreadsheet compliance and accept resumes from validation professionals.
Registration information for the 2013 PDA/FDA Joint Regulatory Conference is available.
Tyson Mew, president of Ofni Systems will be at the 2012 PDA FDA Joint Regulatory Conference in Baltimore, MD on September 10-12. The PDA FDA conference has the title “Compliance through Quality Systems: Implementing & Advancing a Sustainable Global Quality Culture”. In joint collaboration with the FDA, PDA has designed the conference to reflect how a robust quality system can enhance business goals and objectives. The conference will feature a series of regulatory and industry leaders in quality and compliance.
Registration information for PDA FDA Joint Regulatory conference is available.Ty Mew and Ofni Systems will be available throughout the conference to discuss software compliance, demonstrate their validation automation tools and accept resumes from validation professionals.
About Ofni Systems
Ofni Systems is an industry leader for 21 CFR Part 11/Annex 11 compliance and automating the validation process. Started in 1999, their products for compliant databases and spreadsheets are used by the FDA, pharmaceutical, biotech and medical device companies across the globe. 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. The company’s products for computer validation, auditing and FDA submissions ensure that their clients meet all requirements for electronic records and electronic signatures. Ofni Systems provides live desktop support for superior customer support and training. For more information, call (919) 844-2494 or visit www.OfniSystems.com.
Ofni Systems, Inc.
Phone: (919) 844 – 2494