Supplier Contract Audit Checklist

Senate Small Business and Entrepreneurship Committee Hearing

Jul 26, 2011 (Congressional Documents and Publications/ContentWorks via COMTEX) -- Introduction Senator Cardin, members of the Committee, I am Patrick Gallagher, Director of the National Institute of Standards and Technology (NIST), part of the U.S. Department of Commerce. Thank you for this opportunity to testify today on our perspective regarding the .The Role of Small Businesses in Strengthening Cybersecurity Efforts in the United States.. We recognize that small businesses play an important role in the U.S. economy. Since use of the Internet is critical in the delivery of goods and services for all businesses, the importance of addressing risks associated with doing business in a cyber environment cannot be overstated. Today I will focus my testimony on the role small businesses are playing in helping the U.S. Government strengthen our cybersecurity efforts and programs, as well as providing information on NIST's cybersecurity programs and activities that can assist small businesses. Ensuring that business related information is secure is essential to the functioning of our economy -- and indeed to our democracy. Small businesses, like all organizations, want to embrace and have available the latest advances in technology to make their tasks easier, improve productivity, and remain competitive. But they face an enormous challenge in protecting their information in a cyber environment. In fact, it was recently reported n1 that data and identity theft are impacting small and medium-sized businesses more than individuals. More than 99 percent of all U.S. businesses are small or medium-sized n2; a vulnerability common to a large percentage of these organizations could pose a significant threat to the Nation's economy and overall security. Many of these businesses house very sensitive personal information, including healthcare or financial information. Many small businesses also provide services to our federal, state, local and tribal governments and have access to government information or systems. In the interconnected environment in which we all operate, it is vital that this important sector of our economy be aware of the risks and take appropriate steps to ensure their systems are secure.

Vendor Qualification Auditing for FDA Computer System Compliance ...

We will show how audit findings of competitive vendors may be used to select products and negotiate pricing and terms. We will examine the audit process from initial request to conduct an audit through the conduct of on site inspection, closing meetings and audit reports.

Illustrations of observations and remediation plans will be used throughout. The various types of audits will be discussed, including initial qualification, remediation, routine, for cause and correspondence. The seminar will include sample forms and checklists which may be used by the participants, along with some initial training on the appropriate use of forms and checklists.

Group Price: $349 ($50 Off Regular Price)

Recording Only (Download or CD): $299 This webinar will provide valuable assistance to all regulated companies that need to prepare for inspection of the facilities, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. Contract facilities providing clinical, laboratory and data systems will also benefit.

The employees who will benefit include:

End-users responsible for testing QA managers and validation personnel Information systems managers and personnel Senior Quality, Facilities and R&D Management Regulatory Affairs staff Quality system auditors

Attendees will receive these free gifts:

Subscription to FDA Digest – 483/warning letter e-newsletter Six-month subscription to SMARTERCOMPLIANCE™ newsletter by Cerulean Associates ($129 value) Expert, easy-to-grasp guide on Quality-by-Design, (QBD) by Cerulean Associates “Lean Compliance for Midsized Companies” (from Journal of GXP Compliance, January 2008)

About The Presenter:

Rich Poser, is President of First Quality Inc., a quality consulting firm focused on Quality Systems, Training and Validation. Their clients include biotechnology, pharmaceutical and medical device manufacturers, as well as the vendors such as contract laboratories, instrument manufacturers, contract manufacturing sites and software developers that support these highly regulated industries.

Dr. Poser was Director of Analytical Sciences and later Director of Information Systems at the Fisons Pharmaceuticals site in Rochester, NY. Following work in product development, laboratory automation, and validation and quality systems for the Mylan Pharmaceutical Company, Rich joined Dura Pharmaceuticals in San Diego as Analytical Laboratory Director and Director of R&D Quality Assurance. After the acquisition of Dura by Élan, Rich was appointed Director of Quality Laboratory Operations and led their 21CFR Part 11 training and audit team.

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