Thursday, September 23, 2010

FDA GMP Enforcement: Avoid the
Public Spotlight

GMP violations are back in the headlines with a vengeance, the public riveted by tales of phantom recalls, deadly substitute ingredients, doubly thick tablets, the list goes on...

Make sure you are not the next one to have to take the witness stand in Congress or face criminal charges because of a quality oversight by your staff. With FDA issuing more warning letters than it has in years, and acting quickly on seizures, injunctions, consent decrees and criminal prosecutions – it is more important than ever to ensure that your organization is in full compliance.

In just 90 minutes, Joe Famulare, a former FDA deputy director, now Global Head of Quality, External Relations and Collaboration, for Genentech, and Raymond Bonner, Partner at the Washington, D.C., law firm, Sidley Austin, will discuss the impacts of recent FDA enforcement initiatives and how to successfully prepare for an inspection. They will focus on foreign inspection priorities, protecting your global supply chain and successful post-inspection communication.

During this webinar, you will discover:

• 5 key GMP enforcement areas - from root cause investigations to documented validation
• What the top 5 QSR compliance issues are and how to correct them before an inspection
• The Quality Unit: significant authority - complex responsibilities
• How to be protected from increasing strict liability criminal prosecutions
• Why data integrity and supplier quality are at the forefront of foreign inspections
• Successful responses to warning letters: 15 days to the finish line

Raymond and Joe will also answer your team's questions in the Q&A session.

Who should attend...

• Auditors
• Executives
• QA/QC managers
• Training personnel
• Compliance officers
• General/corporate counsel
• Risk management specialists
• Regulatory affairs professionals

For one low price, you and your entire team from one location can take part in this fast-paced, insightful webinar. Best of all, you'll be able to connect personally with our panelists when we open up the phone lines for live Q&A.

SPEAKER

Joe Famulare Global Head of Quality, External Relations and Collaboration Genentech Joe Famulare Is the Global Head of Quality, External Relations and Collaboration, for Genentech, A Member of the Roche Group, based in Washington, D.C. In that role he interacts with various groups and health authorities on quality and compliance matters and provides subject matter expertise on key quality and compliance strategic activities in the Roche Pharma Technical Global Quality organization. Prior to joining Genentech, Joe worked for the US Food and Drug Administration for 32 years. Joe began his career with the FDA in 1977 as an investigator in what was then referred to as the Newark District. Since that time Joe has held key leadership roles within the FDA to include Branch Chief, Case Management and guidance Branch DMPQ, OC, CDER, Director of Manufacturing and Product Quality, CDER Office of Compliance and most recently Deputy Director, CDER Office of Compliance. In CDER, Joe was one of the founding members of the CGMP for the 21st Century Steering Committee and then the Council for Pharmaceutical Quality.  He was a leader of the Quality Systems Work Group and Part 11 Work Group.  He led many international negotiations and was involved in agreements with EMEA, EU member states, Japan, Australia and many other regulatory partners.  He has actively worked on the International Conference on Harmonization (ICH), representing FDA in various capacities since the ICH quality vision was put in place in 2003. Raymond A. Bonner Partner Sidley Austin LLP Raymond A. Bonner is a partner at Sidley Austin LLP and is resident in the firm's Washington, D.C., office. He is Chair of the firm's Food, Drug and Medical Device Enforcement and Compliance Group. Mr. Bonner is also a member of the firm's Executive Committee. Mr. Bonner has represented numerous pharmaceutical and medical devices companies in connection with government enforcement matters. These matters have involved a range of issues including GMP and QSR, drug safety, clinical, marketing and pricing. Regarding manufacturing, he has worked with numerous sites throughout the world concerning quality and related regulatory issues. Mr. Bonner previously served as an Assistant U.S. Attorney in the District of Maryland for six years, where he presented major pharmaceutical fraud and GMP cases, and litigated other FDA-related cases. Throughout his tenure as a prosecutor, Mr. Bonner counseled FDA and its Special Prosecution Staff investigating the healthcare industry. Mr. Bonner is the recipient of FDA's Harvey W. Wiley Medical and Commissioner's Special Citation.

Webinar Details

DATE: Thursday, September 23, 2010
TIME: 1:00 PM ET • 11:00 AM MT • 10:00 AM PT
DURATION: 90 Minutes

Benefits

What does registration get me?

• One (1) phone line, for you alone, or around which to gather your team(s). Toll-free in the U.S. only.
• One (1) password to a website on which you'll be taken through the presenters' slides as they speak to them.
• An interactive Q&A round with speakers by phone and electronic submission.
• The insight you've come to expect and respect from Elsevier Business Intelligence and our guest speakers.

• Convenience—and lower cost. Your entire team can listen in one room. No travel required!
• A team approach. You've often wanted to have everyone on your team getting the same knowledge and insight you derive from physical conferences. Now you can.
• Interactivity. You're remote, but not removed. Our webinars let you ask the important, burning, controversial questions of our speakers that you'd be able to pose at a physical conference.
• Flexibility. Want to be able to review what you learn? No problem ... just register for the live webinar PLUS a digital copy of the entire event to listen to at your convenience. Interested in the topic but have a scheduling conflict? Don't worry — the recording is available for purchase at any time

SUPPORTING PUBLICATIONS

REGISTRATION

• $349 - Recorded Webinar with Complete Transcript, click here
• Register by email: custcare@elsevier.com
• Register by phone: +1 (800) 332-2181 (U.S.) / +1 (908) 547-2159 (non- U.S.)

Webinar Cancellation Policy: No refunds or credits will be given one week prior to the scheduled webinar, or after the webinar presentation materials and access instructions have been sent to participants. In lieu of cancellation, you may substitute another delegate from your company as a replacement.