New Hampshire Bio/Med Council Best In Bio Series
FDA Inspection - R U Ready?
Sheraton Harborside
Portsmouth, NH
The New Hampshire Bio/Tech Council held the second in it's Best In Bio Series on Thursday June 10, "FDA Inspection – R U Ready?" at the Portsmouth Sheraton Harborside. The NH Bio/Medical Council is a non-profit organization that supports and promotes economic development in New Hampshire by bringing together academic, industrial and government participants in the medical device, biotech and pharmaceutical industries.
More than 60 attendees heard four world class speakers present individually and then participate in a lively panel discussion that addressed recent changes in Food and Drug Administration compliance and enforcement. The FDA has recently announced plans to increase criminal prosecutions of individual corporate executives under the strict liability provision of the Food Drug and Cosmetic Act. For example, a major New England-based medical device company recently plead guilty to two misdemeanors and agreed to pay $296 million in fines.
Captain Mutahar Shamsi, Director of Compliance for the FDA New England District, led off the presentations, describing his organization and how in 2010 they plan to inspect approximately 600 of the almost 3,000 medical device companies in his district. Theresa McCarthy, Chair of the Boston Section of the American Society for Quality and Sr. Compliance Specialist for Pfizer, gave an industry perspective on how companies can prepare for both planned and unannounced FDA inspections. Dan O'Leary, President of Ombu Enterprises of Swanzey, NH, detailed what the most common causes are for companies to get unfavorable FDA inspection outcomes. Lastly, Karen Green, a partner at Wilmer Hale, a Boston law firm, reviewed recent criminal and civil actions that FDA has taken against US medical device and pharmaceutical companies, with some companies being subject to fines of over $1 billion.
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Captain Mutahar Shamsi, Director of Compliance, FDA New England District (View Presentation)
Captain Shamsi is currently the Director of Compliance Branch (DCB) for the Food and Drug Administration's (FDA) New England District Office. He started with FDA as an Engineering Analyst at Winchester Engineering and Analytical Center in 1985. He transferred to the District Office in 1990 where he has worked as an Information Technology Specialist, Investigator, Device Pre-Approval Manager, Device Team Leader and Compliance Officer. Prior to becoming the Director of Compliance, Captain Shamsi was a Supervisory Investigator (2002) responsible for the Boston MA and Providence RI Resident Posts (2003-2006). Captain Shamsi holds a B.S. in Biomedical Engineering (1985) and a M.S. in Electrical Engineering (1989) from Boston University as well as a M.S. in Computer Science (1995) from the University of Massachusetts, Lowell. He is also an FDA Office of Regulatory Affairs Certified Level II Medical Device Performance Auditor.
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Theresa McCarthy, Chair of American Society for Quality Boston Section, Senior QA Compliance Specialists Pfizer (formerly Wyeth BioTech) (View Presentation)
She is an experienced RABQSA Lead Auditor, Project Manager and Trainer.
She has developed and delivered compliance based workshops for Merrimack College, New Hampshire Manufacturing Extension Partnership (NHMEP), Information Mapping and Perry Johnson Inc.
As the Senior Compliance Specialist for a Pfizer she conducts internal and external audits.
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Dan O'Leary, President of Ombu Enterprises, Swanzey, NH (View Presentation)
Mr. O'Leary has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics, focusing on logic and number theory. His professional experience relates to quality, reliability, and operations management. Dan is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence. Ombu helps companies achieve efficient and effective processes and regulatory compliance.
Dan is a regular speaker at international conferences including ASQ, ISM, and RAMS. Dan teaches courses in reliability methods, medical device regulations and practices, statistical methods, management systems (ISO 9001, FDA QSR, & ISO 13485), and project management. Dan is a member of the American Mathematical Society, American Statistical Association, Society of Industrial and Applied Mathematicians, Institute for Supply Management, Project Management Institute, APICS, and is a Senior Member of the American Society for Quality and has held leadership positions in ASQ sections. He is an ASQ Certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; he holds an APICS certification in Resource Management.
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Karen F Green, Partner, Wilmer Hale, Boston, MA (View Presentation)
Karen Green is a partner in the firm's Litigation/Controversy Department and a member of its Investigations and Criminal Litigation and Government and Regulatory Litigation Practice Groups. She also chairs the firm's Pharmaceutical and Healthcare Group. She joined the firm in 1982. Ms. Green served as chair and co-chair of Wilmer Hale's Litigation Department from 2002 to 2007, and now serves on its Litigation Executive Council.
Ms. Green's practice concentrates on complex business litigation, including the defense of white-collar criminal and False Claims Act litigation. She has extensive experience representing companies and corporate officers and directors, particularly within the health care industry, in parallel civil and criminal proceedings alleging: violations of the Anti-Kickback Statute, the Food Drug and Cosmetic Act, and the Export Control Act; health care fraud; securities fraud; government contracting fraud; consumer fraud; conspiracy; and mail and wire fraud. At the request of corporate clients, she also has conducted internal investigations.
About the New Hampshire Bio/Medical Council:
The New Hampshire Bio/Medical Council strives to promote economic development in New Hampshire with long-term goals in education, business development, job creation and retention. Established in 1999, the Council has worked steadily to establish a strong identity for the industry in New Hampshire. Our goal is to network the academic, industry and government participants into a cohesive whole and to provide consortiums for human resources, service providers and purchasing to support companies and affiliates in our industry.
For more information, contact:
Paula Newton at president@nhbiomedical.org