Seventh Annual FDA Inspections Summit

September 19-21, 2012

Each year, the FDA makes adjustments to its inspection processes and policies. This year is no exception. Recent important changes include:

• If you think you can easily stop the FDA from taking pictures of your facility during an inspection, think again.  The FDA now advises its inspectors to not ask for permission but take their cameras into facilities and take pictures as they see fit.  If a firm complains, the new policy is for the inspector to contact the firm’s legal counsel and advise the district management immediately.

• A new user fee may be assessed if FDA conducts a reinspection to evaluate corrective actions that were classified Official Action Indicated (OAI) and determined to be material.  This fee may also be assessed for not complying with a recall order issued by FDA under section 423 or 412(f).

• FDA investigators are actively data mining your records during inspections.  As nearly all inspectors are using laptops and tablets during their inspections, many are asking for electronic copies of complaint or AER data and taking it back to their hotel rooms each evening to dissect the data and be prepared to ask additional questions the next morning.  Providing old or inaccurate data can quickly lead to problems.

These changes and many more are to be discussed at the Seventh Annual FDA Inspections Summit.  Year after year, the crème de la crème of the industry make it their business to attend this conference and tap into the cumulative knowledge of an accomplished group of top officials from CDER, CDRH, CBER, the Office of Regulatory Affairs (and more).

Register today to hear about breaking news directly from prominent FDA officials. That's why you can't afford NOT to attend the Seventh Annual FDA Inspections Summit on Sept. 19-21 in Bethesda, MD.

Featured Speakers:

• Steve Silverman, Director, Office of Compliance, CDRH, FDA
• Lori Lawless, SCSO, Medical Device Specialist, ORA, FDA, Baltimore District
• Mary Malarkey, Director, Office of Compliance Biologics Quality, CBER, FDA

Summit Faculty:

• Barbara Immel, President, Immel Resources (Summit Chairperson)
• Steve Niedelman, Lead Quality Systems and Compliance Consultant, FDA & Life Sciences Practice, King & Spalding, former Deputy Associate Commissioner, Regulatory Operations and Chief Operating Officer, ORA, FDA
• Ron Johnson, President, Becker & Associates Consulting, Inc., former Director of Compliance, CDRH, FDA
• Dr. Gilda D’Incerti, CEO, Pharma Quality Europe
• Deborah Geyman, Senior Manager Corporate Quality Audit, St. Jude Medical
• Dr. Stephen Goldman, Managing Member, Stephen A. Goldman Consulting Services, formerly FDA’s first Medical Director of MedWatch
• Steven Grossman, President, HPS Group, Deputy Executive Director, Alliance for a Stronger FDA, Publisher, FDA Matters: The Grossman FDA Report, former Deputy Assistant Secretary for Health, HHS
• Connie Hoy, Vice President, RA/QA, Cutera
• Julie Larsen, Director, Inspection Readiness Services, BioTeknica
• Dr. Jeanne Mattern, Director, QHS Regulatory Compliance Office, Cleveland Clinic
• Dan O'Leary, President, Ombu Enterprises
• Matt Quirk, Manager, Clinical QA, St. Jude Medical
• Kenneth White, Principal Scientist, Clinical Research and Bioscience Group, Social & Scientific Systems
• Christina Arnt, Post Market Surveillance Manager, St. Jude Medical
• Braulio Ortiz, Principal/Sr. Quality Consultant, BioTeknica
• David Elder, Vice President of Strategic Compliance Services, PAREXEL Consulting
• Elaine Messa, Executive Vice President of the Medical Device Practice, Becker & Associates Consulting, Inc.
• Michael Bloh, Independent Safety and Pharmacovigilance Consultant
• Frederick Branding, Principal Attorney, Olson Frank Weeda
• Scott Cunningham, Partner, Covington & Burling
• Darshan Kulkarni, Principal Attorney, The Kulkarni Law Firm
• Cathy Burgess, Partner, Alston & Bird

Register Today

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