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Revised as of July 25, 2011
Click here to view the agenda.
Despite the FDA’s ongoing work with international regulators to improve supplier quality issues, a top FDA official has stated that another public health crisis like Heparin “seems inevitable.”
All together the number of offshore suppliers has nearly tripled in recent years. China alone has nearly 1,000 makers of drug substances and only a small percentage of inspections.
Whether you make drugs or devices, biologics or third-party goods, when your suppliers slip up, it’s you the FDA comes after. Ideally, the regulators should be covering your back with tough inspections of offshore suppliers … but realistically, the agency simply is spread too thin to do the job.
Learn how to assure the integrity and quality of your supply chain. Put yourself at the head of the class and avoid 483s … warning letters … lawsuits … by taking the lead.
You can take charge of your supply chain by joining the top speakers in Washington in August for the tools you need. Mark your calendar for the Third Annual Supplier Quality Management Congress, Aug. 9-11, 2011, in Bethesda, MD.
It’s a day and a half of intensive learning, a crash course in supply chain management and monitoring. Here’s just a taste of what you’ll discover:
Your faculty is an all-star cast of industry stars, members of the bar, consultants, and invited FDA officials, including:
Conference Co-Chairs John Avellanet of Cerulean Associates LLC and Steven Sharf of GMP Concepts will be on hand to keep matters on track and moving forward.
Invaluable Pre-conference Workshops
Register today and take advantage of the in-depth instruction at our two pre-conference workshops on Tuesday, Aug. 9.
Medical Device Supplier Qualification and Management — Practical Approaches to Cost Effective Implementation
Dan O’Leary, President, Ombu Enterprises
John Avellanet, Principal Consultant, Cerulean Associates (Co-chair)
Regulators around the globe are looking more closely at supplier management issues as device manufacturers extend their processes down the supply chain and acquire components across national boundaries.
Are you ready for the increased scrutiny from FDA investigators and Notified Bodies?
You can start to prepare with important GHTF guidance documents:
But they only provide the foundation, not the practical details. This workshop gives you the tools and methods you need for a cost effective implementation. Attendees will learn:
BONUS: Attendees will receive copies of implementation tools including a process map, sample questionnaire, reevaluation form, audit checklist and more.
Creating Pharmaceutical Supplier Quality Agreements
Steven Sharf, President, GMP Concepts
William Reiss, Senior Manager, Supplier QA Agreements & Global Sample Retention, Celgene
While these contracts are required by regulations and guidance, there are no clearly outlined expectations for them. ICH Q7A 16.12 simply read, “There should be a written and approved contract or formal agreement between the contract giver and the contract acceptor that defines in detail the GMP responsibilities, including the quality measures, of each part.” In this workshop attendees will learn how create, and format quality agreements to show strengths in the documents and avoid the potential consequences of inadequate quality agreements.
New for 2011 — Live on-line viewing of the entire Third Annual Supplier Quality Management Congress
Can’t make it to the Third Annual Supplier Quality Management Congress? Attend the live sessions from your computer. Participate in the live conference from your home or office. Watch the live streaming video of the presenter and view the presentation materials in real-time. Ask questions of the presenters and download handout materials. By registering you will also receive six months access to archived session recordings after the conference ends. Registration is quick and accessing the live sessions is as simple as clicking your mouse.
Who Will Benefit
About Your Co-Chairs
John Avellanet, Principal Consultant, Cerulean Associates
John Avellanet is a former medical device and biopharma executive who created, developed and ran a Fortune 50 subsidiary's records management and information technology departments. He co-founded Cerulean in 2006, and today is an internationally acknowledged expert, speaker and syndicated author on lean FDA compliance and FDA/ICH Quality by Design. He is a regular columnist for the quarterly Journal of Commercial Biotechnology where he writes on the practical aspects of compliance, quality systems and preventing industrial espionage, and the magazine Pharmaceutical Processing where he writes about IT compliance issues, such as Part 11 and Annex 11.
Steven Sharf ASQ-CPGP, President, GMP Concepts
Steven Sharf has 17 years in the pharma industry with roles of varying responsibility. Mr. Sharf’s most recent position was with Merck, where he served the role of quality manager in the newly formed Supplier Quality Assurance group. He was responsible for the day-to-day relationship management between Merck and some of their key and strategic suppliers. Prior to the merger of Merck and Schering-Plough, Mr. Sharf was a regional manager with Schering-Plough’s Global Quality Supplier Management Group, responsible for audit activities of suppliers in the Americas as well as suppliers providing materials to API manufacturers; and, at Novartis, he conducted supplier audits and executed the very same supplier certification program he talks about for raw materials and package components. Currently, Mr. Sharf is the President of GMP Concepts, a consulting company he started based on his years of experience in the quality and compliance arenas.
Dates and Location
Aug. 9–11, 2011
Bethesda North Marriott Hotel & Conference Center
5701 Marinelli Road
Bethesda, MD 20852
Toll free: (800) 859-8003
Tel: +1 (301) 822-9200
Room rate: $159 single or double (plus 13 percent tax)
Hotel reservation cutoff date: July 18, 2011
Register Early — Space is Limited
Hurry — register early because space is limited! Your tuition includes the day-and-a-half summit, all summit materials, continental breakfast each day and lunch on the first day.
Complete Congress and Workshop
Livestreaming Full Conference
(including 24/7 access to the content for six months after the event)
Send Your Team for Maximum Benefit
Call (888) 838-5578 in the U.S. or +1 (703) 538-7600
Payment is required by the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to FDAnews.
Or, register by phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600.
Cancellations and Substitutions
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.
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