Second Annual FDA Inspections Summit Getting it Right the First Time, Every Time
Product Details
“The FDA Inspections Summit was one of the most informative and useful conferences I have ever been to.”
- Nicole Landreville, Director of Quality and Regulatory Affairs, Xltek
Hear top FDA officials and industry leaders provide insight on what to expect in 2008 and how to better manage your inspections and compliance strategies. You’ll participate in intensive workshops, listen to keynote presentations by officials and experts and choose between three specialized tracks (drugs/biologics, devices and clinical trials) focusing on the latest inspections strategies.
- Explore step-by-step strategies to respond to 483s and warning letters
- Preview ORA’s inspectional and enforcement priorities for the coming year
- Grasp the details on CDRH's inspectional programs and data trends from fiscal 2007
- Find out about the new inspection initiatives for CDER
- Gain a thorough understanding regarding the scope of — and limitations on — FDA's inspectional authority
- Learn what employees should not say during an inspection and strategies for preventing them from doing so
- Discover best practices for managing the inspectional process in an outsourced business environment
- Examine FDA inspection trends for complaint and pharmacovigilance systems
- Acquire preparation strategies for the unannounced inspection
Featured FDA Speakers
David Elder, Director, Office of Enforcement, ORA, FDA | Mary Malarkey, Director, Office of Compliance and Biologics Quality, CBER, FDA | ||
Michael Marcarelli, Director, Office of Bioresearch Monitoring, CDRH, FDA | Barry Rothman, Consumer Safety Officer, CDER, FDA | ||
Larry Spears, Deputy Director for Regulatory Affairs, CDRH, FDA |
Featured Speakers
David Chesney, Vice President of Strategic Compliance Services, PAREXEL Consulting; former FDA district director for the San Francisco office | John Godshalk, Senior Consultant, Biologics Consulting Group; former FDA inspector in the Division of Manufacturing and Product Quality, CBER | |||
Robert Lewis, President, IHL Consulting Group; former FDA inspector and co-leader of Atlanta district drug team | Janis Olson, Senior Validation Consultant, EduQuest; former FDA supervisory investigator and director, Information Technology | |||
Steven Niedelman, Executive Vice President, Quintiles Consulting; former FDA deputy associate commissioner for regulatory operations | Michael Beatrice, Vice President, Corporate Regulatory and Quality, Abbott Laboratories; former Assistant Surgeon General and former Deputy Director, CBER, FDA | |||
Tamera Norton Smith, President and Senior Consultant, Norton Audits; former FDA investigator | Stephanie Gray, Director, Corporate Compliance, Boston Scientific; former Director, Office of Compliance, for CDER, FDA |
Click here to see what previous attendees have to say.
Consider this:
The rate of warning letters issued to inspections conducted increased 13 percent in 2006. At the same time, Class I recalls went up more than 200 percent from 2005.
High profile incidents, such as the Bausch & Lomb contact lens solution recall and the recent Avandia and Zelnorm safety studies, have shined the spotlight on the FDA — and all the businesses it regulates.
Companies that do not comply with FDA requests will face greater fines and penalties, making the stakes for inspections higher still.
The inspections landscape is changing. Are you prepared?
Attend the Second Annual FDA Inspections Summit.
- Recognize the criteria the FDA uses to determine the seriousness of GMP deviations
- Determine how to best prepare for preapproval inspections for combination products
- Identify the compliance issues that guarantee trouble and how to avoid them
- Understand clinical edata: What problems FDA inspectors are trained to look for
- Develop meaningful training system metrics within the regulated industry
- Know how to ensure your clinical trial investigators aid in successful FDA inspections
Pre-conference Workshop
Register now for the preconference workshop:
- RSVP (Response Shall Validate Performance): Crafting Effective Responses to 483s and Warning Letters Step by Step
Frederick Branding, Partner, Reed Smith LLP
Cathy Burgess, Senior Counsel, Regulatory Law, American Red Cross
This workshop will show attendees the information and wording that the FDA expects in a complete and adequate response.
Conference Sessions
Register now to attend all of these conference sessions:
- ICH E6 Essential Documents: Auditing the Trial Master File
Carl Anderson, Senior Consultant, Biologics Consulting Group; former FDA investigator
- Do It Yourself: Proof of Year-Round Compliance Efforts the FDA Expects to See in an Inspection
Raymond Bonner, Partner, Sidley Austin
- Managing Employee Conduct During Regulatory Inspections — A View From Both Sides
Michael Beatrice, Vice President, Corporate Regulatory and Quality, Abbott Laboratories; former Assistant Surgeon General and former Deputy Director, CBER, FDA
- Best Practices for Managing the Inspectional Process and "War Room" in an Increasingly Outsourced Business Environment
Andrea Chamblee, Compliance Manager, Otsuka America Pharmaceutical
- Inspection of Complaint Systems: Strategies for Investigations Under 21 CFR 211.198
David Chesney, Vice President of Strategic Compliance Services, PAREXEL Consulting; former FDA district director for the San Francisco office
- The FDA is Knocking at Your Door: Be Prepared for the Unannounced Inspection
John Eckberg, Director, Quality, PharmaLinkFHI
- FDA’s Office of Regulatory Affairs: 2007-2008 Enforcement Update
David Elder, Director, Office of Enforcement, ORA, FDA
- Preparing for Preapproval Inspections: Biologics, Devices and Combination Products
John Godshalk, Senior Consultant, Biologics Consulting Group; former FDA inspector, Division of Manufacturing and Product Quality, CBER
- A Third Party Inspection Results Process
Stephanie Gray, Director, Corporate Compliance, Boston Scientific; former Director, Office of Compliance, for CDER, FDA
- Strategic Compliance: Practical Ways to Prevent Compliance Failures
Barbara Immel, President, Immel Resources LLC, (Chairperson)
- Compliance Issues That Guarantee Trouble: How to Address and Avoid Them
Robert Lewis, President, IHL Consulting Group; former FDA Inspector and co-leader of Atlanta district drug team
- Regulation of Device Software
Anna Longwell, President, Longwell and Associates
- Compliance Update on Device Clinical Research: Details on CDRH's Inspectional Programs and Data Trends From Fiscal 2007
Michael Marcarelli, Director of Bioresearch Monitoring, CDRH, FDA
- Current Challenges in Biologics Compliance
Mary Malarkey, Director, Office of Compliance and Biologics Quality, CBER, FDA
- Strategizing for Inspection Success: Case Studies in Staging Information During FDA Inspections
FrancesAnn McKenney, Director of GCP Compliance at Genitope
- Houston, We Have a Problem: Who to Contact and How to Interact With the FDA When Trouble Comes
Steven Niedelman, Executive Vice President, Quintiles Consulting; former FDA deputy associate commissioner for regulatory operations
- Clinical edata: What Will the FDA Investigator Look For?
Janis Olson, Senior Validation Consultant, EduQuest; former FDA supervisory investigator and director, Information Technology
- Don't Say That! Managing Employee Conduct During Regulatory Inspections
Mark Rohlfing, Director of Quality, Almac Clinical Services
- Inspectional Outlook
Barry Rothman, Consumer Safety Officer, CDER, FDA
- Upfront GCP Compliance: Understanding Risk Mitigation for Successful FDA and Business Outcomes
Tamera Norton Smith, President and Senior Consultant, Norton Audits; former FDA investigator
- Warning Letters and Managing Related Legal Issues
Larry Spears, Deputy Director for Regulatory Affairs, CDRH, FDA
- Hold On a Minute: Understanding the Scope of — and Limitations On — FDA's Inspectional Authority
Frederick Stearns, Partner, Keller and Heckman LLP
- Pilot Multipurpose Audit Program -- Qualifying and Preparing for US/Canada Joint Inspections
Marc-Henri Winter, Executive Manager, G-MED North America, Inc.
Register now for the Complete Summit and save over $250!
Who Should Attend
- Executive Management
- Regulatory Affairs
- Quality Assurance/Quality Control
- Legal and Compliance Officers
- Clinical Research Directors
- Consultants/Service Providers
About the Conference Chairperson
Barbara K. Immel, conference chair, is president of Immel Resources LLC, a management consulting firm specializing in quality systems, regulatory compliance and training. For more than 25 years, Barbara has been one of the most listened to voices in regulated industry, and she has helped many companies improve their compliance track records. Barbara served as the compliance columnist for BioPharm Magazine from 1996-2007, and she is currently editor of the Immel Report ™ newsletter.
Barb has taught industry topics at the University of Wisconsin at Madison, the University of California Berkeley, Stanford University and the University of Georgia. She is a graduate of the Buckley School of Public Speaking, Stanford Professional Publishing Course and the University of California, Santa Barbara. She has published more than 50 articles in industry trade journals on a variety of subjects and is the author of the Quality Assurance chapter in Dekker’s Encyclopedia of Pharmaceutical Technology. Honors and awards include Who’s Who in the World, Who’s Who in America, Who’s Who in American Women, Who’s Who in Medicine and Healthcare, and Who’s Who in Finance and Business.
Here's what previous attendees have to say:
"The FDA Inspections Summit was one of the most informative and useful conferences I have ever been to. The chair, Barbara, was simply fantastic. Keep her on the program for next year!"
- Nicole Landreville, Director of Quality and Regulatory Affairs, Xltek
"Usually there are only a few stand out speakers, but there were excellent speakers throughout the entire conference ... Breakout sessions focus on my particular interest/concern ... Cost/value was appropriate."
- Karen A. Vasquez, Regulatory Analyst, Boehringer Ingelheim Roxane, Inc.
"Excellent lineup of content expert speakers."
- Tony Stuckwisch, QA Manager Product Compliance, Schwarz Pharma
"Very high quality speakers. Very useful information."
- Raymonde Veilleux, QA Director, The ChulResearchCenter
"I enjoyed the overall knowledge and experience of the speakers and the quality of the presentations."
- Christina Darden, QA Specialist, RTI Health Solutions
"I specifically liked the variety of speakers."
- Goldy Singh, QA Manager, Xltek
"Well done!"
- Jennefer Ramos, QA Engineer, Ventracor
Click here to view a list of companies who attended last year.
Location and Hotel Accommodations
To reserve your room, call the hotel at the number below. Be sure to tell the hotel that you’re with the FDAnews conference to qualify for the reduced rate. Only reservations made by the reservation cutoff date are offered the special rate, and space is limited. The hotel may run out of rooms before the reservation cutoff date. The discounted rate is also available two nights before and after the event based on availability. The hotel may require the first night’s room deposit with tax. Room cancellations within 24 hours of the date of arrival or “no-shows” will be charged for the first night’s room rate plus tax.
Bethesda North Marriott Hotel & Conference Center
5701 Marinelli Road
Bethesda, MD 20852
Toll free: (800) 859-8003
Tel: 1 (301) 822-9200
www.bethesdanorthmarriott.com
Room rate: $219 single or double (plus 12 percent tax)
Hotel reservation cutoff date: Sept. 30, 2007
Fee |
|
Complete Summit |
$1,997.00 |
Conference Only |
$1,697.00 |
Pre-Conference Workshop Only |
$597.00 |