In 1991 the pharmaceutical industry met with FDA to determine how best to accommodate paperless record systems under CGMP regulations. The final result, published in 1997, was 21 Code of Federal Regulations Part 11. It provides industry with quantitative information for electronic records and signatures that can be used to add value to the validation of automated systems. Part 11 regulations can be used to accomplish three tasks: create new requirement specifications that comply with Part 11 regulations, assess existing automated systems for Part 11 compliance, and remediate Part 11 compliance gaps in existing automated systems.

In this audio conference, attendees learn how they can quickly and easily assess and remediate their current systems for Part 11 compliance, and how to add value by incorporating Part 11 into the validation effort.

This audio conference covers:

• How to determine if a system to be purchased will comply with Part 11 before purchasing it
• How to efficiently incorporate Part 11 compliance into your validation effort
• How to assess existing systems for Part 11 compliance
• How to remediate existing systems for Part 11 compliance
• Table 1: Summary of 21 CFR Part 11 Requirements for Electronic Records
• Table 2: Summary of 21 CFR Part 11 Requirements for Electronic Signatures

About the speaker:

Jeffrey Gassman has over 20 years of validation experience for pharmaceutical, biotechnology and medical device clients nationally and internationally. He has assessed over 300 CGXP applications for Part 11 compliance and remediation. He earned his B.S. in Chemical Engineering from Clarkson University, and his M.S. in Chemical Engineering from Columbia University.

In 1995, Jeffrey became the President of Validation Plus (VPI). His work and leadership has been instrumental in VPI receiving numerous letters of recommendation. In 2004, Mr. Gassman was elected to Who’s Who in Science and Engineering in America. In 2009, Mr. Gassman was elected to the Presidential Who’s Who (in America).

Who should attend?

• Validation Managers, Specialist & Supervisors
• Quality Assurance Managers, Specialists & Supervisors
• IS/IT Managers, Project Managers & Specialists
• Engineering
• Labeling & Packaging

*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.