7th Annual FDA Inspections Summit, Presented by FDAnews

Attend and Learn the Latest Must-Know Changes the FDA is Making to its Inspection Processes & Policies / Sept 19-21 2012 -- Bethesda MD USA

Falls Church, VA, USA, (PresseBox) - FDAnews announced details today of its 7th Annual FDA Inspections Summit, to be held Sept 19-21 2012, in Bethesda MD USA. The summit is open to all personnel tasked in the inspection readiness process, including legal and compliance officers, clinical research directors, Quality Assurance/Quality Control execs, and any personnel who additionally manage or provide support for inspections for their pharma/medical device company.

To register and take advantage of the summit's early bird rate - in effect until August 21:
Click here [www.fdanews.com/InspectionsSummit]

Each year, the FDA makes adjustments to its inspection processes and policies and 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 snap 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.

SUMMIT TAKES PLACE IN 4 WEEKS (September 19-21 2012)

Companies can be better prepared, and learn more about the above mentioned changes and many more to be discussed at the 2012 7th 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.
You and your staff cannot afford NOT to attend the 7th Annual FDA Inspections Summit on Sept 19-21 in Bethesda MD.

Distinguished FDA Speaker:

- Steve Silverman, Director, Office of Compliance, CDRH, FDA

Summit Faculty:

- Barbara Immel, President, Immel Resources (Summit Chairperson)
- Steve Niedelman, Lead Quality Systems & Compliance Consultant, FDA & Life Sciences Practice, King & Spalding, former Deputy Associate Commissioner, Regulatory Operations & COO, 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, Sr 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 Asst Secretary for Health, HHS
- Connie Hoy, VP of 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
- Katlyn Tissue, Quality Supervisor, Genicon
- Kenneth White, Principal Scientist, Clinical Research & Bioscience Group, Social & Scientific Systems
- Christina Arnt, Post Market Surveillance Manager, St. Jude Medical

Who Should Attend:

- Clinical Research Directors
- Consultants/Service Providers
- Executive Management
- Legal & Compliance Officers
- Quality Assurance/Quality Control
- Regulatory Affairs


7th Annual FDA Inspections Summit
**Presented by FDAnews**
Sept 19-21 2012 -- Bethesda, MD


Early Bird Rate (Must register by Aug 21 2012): $1,797 per attendee
Regular Tuition (Aug 22 to Sept 21 2012): $1,997 per attendee


Online: http://www.fdanews.com/InspectionsSummit
Phone: 888-838-5578 or 703-538-7600
Fax: 703-538-7676
Mail to: FDAnews, 300 N Washington St Ste 200, Falls Church VA USA 22046-3431


You must be entirely satisfied with this learning opportunity or FDAnews will refund your entire tuition, or extend a credit to a future FDAnews conference.


Written cancellations received at least 21 calendar days prior to the start date of the event will receive a refund -- less a $200 administration fee. No cancellations will be accepted -- nor refunds issued -- within 21 calendar days from the start date of the event.

A credit for the amount paid may be transferred to any future FDAnews event. Substitutions may be made at any time. No-shows will be charged the full amount. In the event that FDAnews cancels the event, FDAnews is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.


Significant tuition discounts are available for teams of three or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount. Call 703-538-7600 for details.


FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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