January 21, 2010

Ready for Inspection by Hamburg's FDA? What you should do differently

Under Commissioner Hamburg’s new enforcement policy, FDA has issued more warning letters more quickly than it has in years. In some cases, the agency has even skipped warnings and gone straight from inspectional observations to injunctions and seizures. Clearly, the stakes will be higher at your next surprise inspection. The question is: What steps should you take now to be ready for it?

Here to guide you are two ex-FDA compliance experts with PAREXEL Consulting, Peter Smith and Mark Lookabaugh. They will go over the specific action items necessary for you to be inspection ready at all times, including the use of Quality Systems outlined in ICH Q10 guidance. They will help you prepare for questions about your supply chain from FDA investigators who are increasingly concerned about how you are countering the threats of purposefully adulterated ingredients and counterfeit drug products.  They will also address how to reduce the risk you face with your contract manufacturers, including those overseas. Plus: How to manage the FDA inspection process, discuss any  FDA-483 observations and prepare appropriate written responses under the new 15-day deadline.

• Hamburg's enforcement intiatives
• Key steps to becoming inspection ready
• Strengthening your quality systems with ICH Q10
• Demonstrating control of your supply chain
• Establishing Good Importer Practices
• Managing the inspection process
• Responding to inspectional observations

The discussion will be delivered in a convenient audio conference format, and capped off with an interactive Q&A round.

So join us, in the convenience of your own office, for a thought-provoking analysis. Grab your team (or several teams), a conference room at your office, a phone and a computer with Web access (that last one's optional). No travel required.

SPEAKERS

PETER SMITH is Vice-President, Pharmaceutical Compliance with PAREXEL Consulting (formerly KMI).  Since joining KMI in 1994, he has been working with clients domestically and internationally regarding regulatory and GMP compliance issues. His primary areas of expertise include active pharmaceutical ingredients (APIs); pre-approval inspections (PAIs); sterile and non-sterile dosage forms; FDA foreign inspections; GMP/quality systems, and FDA and international regulatory requirements. Mr. Smith spent more than 22 years with the FDA where he served as the Associate Director, International & Technical Operations Branch, Division of Field Investigations, from 1986 to 1994. Prior to that he began his FDA career in Boston District in 1972, was the Resident Drug/Device Specialist in Bridgeport, CT, and was a member of the FDA’s Foreign Inspection Cadre from 1977.

MARK LOOKABAUGH is a Principal Consultant for PAREXEL Consulting. Mr. Lookabaugh has extensive FDA regulatory experience (laboratory, inspectional and compliance) and provides critical consulting services to regulated clients. He joined PAREXEL Consulting in 2006, after his retirement from FDA with 30 years of service. From 1975 until 1994, Mr. Lookabaugh was an analytical chemist, specializing in pharmaceutical analysis, first at the Boston District Laboratory and then at the Winchester Engineering and Analytical Center (WEAC).  In 1995 he became a Compliance Officer in the New England District Office of FDA and was then selected to be the Compliance Branch Director in 2004, where he served until joining PAREXEL. Mr. Lookabaugh received a B.S. in Chemistry from Worcester Polytechnic Institute in Worcester, MA.

REGISTRATION

• Register online: Click here for the live webinar
• Register online: Click here for the live webinar PLUS recording
• Buy the recording: Click here for just the recorded webinar
• 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.

WEBINAR DETAILS

LAST CHANCE to join!

DATE: January 21, 2010
TIME: 2 PM ET
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
• Online access to the audio and slides of the entire event if you can't attend the webinar live, and still want to hear the content.
• The insight you've come to expect and respect from Windhover Webinars 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!
  

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