When 21 CFR Part 11 was published over 15 years ago, it was supposed to be a positive development. The FDA was giving companies a way to save on paper – and time and money – by opening a pathway to using “Electronic Records and Electronic Signatures.” It was supposed to recognize technical developments that were having an impact on the regulated industries.

It has been over five years since an update to Part 11 was promised. At this point, what is definitely coming are “tag-along inspections” to measure the state of industry compliance and to benchmark where companies stand in terms of compliance. CDER, the center driving this, has indicated that the results may lead to an updated approach to Part 11 compliance, a re-work of the regulation and/or regulatory citations for the companies involved.

This audio conference covers:

• Defining what the “tag-along inspection program” really means
• Key areas CDER is expected to focus on
• What companies can do to prepare
• Current regulatory citations as clues to focus areas
• What is being heard from companies in the field to-date

About the speaker:

John T. English helps clients develop and execute projects within FDA-regulated industries. With over 25 years of experience, his background includes system validation and audits for pharmaceutical and biological production, QA/QC LIMS, CIM, adverse event systems, data archiving, blood processing, medical devices and regulated software. Recently, he was retained for a two-year period to provide subject-matter expert, audit and remediation services for regulated software, as part of a major consent decree effort. He has provided validation consulting and remediation services to global, mid-size and entrepreneurial companies in the pharmaceutical, biologic and medical device industries in the United States, Europe, Israel, India and Japan.

While an active validation practitioner, John also lectures regularly in the US and Europe on Part 11, computer validation and regulatory compliance. He is a member of the FDA-PDA Joint Task Force on Electronic Information and Dynamic Validation. In addition, he was a selected presenter at the both FDA Public Conferences on 21 CFR Part 11 (Washington, DC in 2004 and Philadelphia, PA in 2000). John presented a workshop on Part 11 - Part 2 - at Interphex 2007 (New York City). He has also addressed US-FDA inspection personnel on validation issues, as well as having been the invited guest of the Spanish Association of Industrial Pharmacists (Madrid) and the Czech Pharmaceutical Association (Prague).

Who should attend?

• Quality Assurance– Computer System Validation
• Quality Assurance– Software Validation
• Regulatory Compliance– System & Software Compliance
• Validation Staff– Computer Validation
• Corporate Audit– Computer and Software
• IS Compliance – GxP Systems