Second Annual Supplier Quality Management Congress Assuring the Integrity of Drug and Device Raw Materials and Supply Chain
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Are you ready?
Whether your supplier is on the other side of the world, in this hemisphere or right next door … if a contamination occurs, whether it is accidental or not ... you are responsible. The FDA isn’t going to show up and fix your problems.
With the FDA’s challenge so clearly articulated, there is no better time for you to act than now. What’s your best next step?
Come to Washington Aug. 18–20, 2010, to attend this timely FDAnews conference: the 2nd Annual Supplier Quality Management Congress.
Last year, this event was a runaway best seller. For 2010, FDAnews has pulled out all the stops to make it even better. Attend and you’ll hear from an all-star speaker lineup from both government and industry, including:
- Kimberly Trautman, Office of Compliance, CDRH, FDA
- Carmelo Rosa, Division of Manufacturing & Product Quality, CDER, FDA
- Steve Niedelman, Senior Consultant, Crowell & Moring
- Jackie Torfin, Director of Quality, Arizant Healthcare
- Jeff Kasoff, Director of Regulatory Affairs, Life-Tech
- Londa Ritchey, Director Supplier Quality, Pfizer
- Dan O’Leary, President, Ombu Enterprises
Your congress co-chairs are John Avellanet of Cerulean Associates and Michael Gregor of Compliance Gurus Inc. Their combined experience as executives, authors and consultants to leading industry organizations ensure that the Supplier Quality Management Congress will be the “can’t miss” event of summer 2010.
In addition, because you rely on so many others to make your products, we’ve invited an exciting roundtable comprised of representatives from top industry groups and companies for an extra-special session you won’t want to miss.
This “suppliers meet customers” panel will help foster the cooperation and compliance needed to thrive under that current financial and regulatory scrutiny. Participants will include:
- International Pharmaceutical Excipients Council (IPEC)
- Rx-360
- Active Pharmaceutical Ingredients Committee (APIC)
- Society of the Plastics Industry (SPI)
- National Electrical Manufacturers Association (NEMA)
- DuPont
Arrive early on Wednesday, Aug. 18 and take advantage of the in-depth instruction at our two pre-congress workshops. This year, in concurrent workshops, we’re covering how to write expert supplier quality agreements for medical devices or pharmaceuticals.
Pre-Congress Workshops Workshop A Creating Comprehensive Medical Device Supplier Quality Agreements That Reduce Risk and Improve Contract Deliverables Dan O’Leary, President, Ombu Enterprises A quality agreement is a written contract between client and supplier that is intended to prevent critical details from “falling through the cracks.” While these contracts are required by regulations and guidance, there are not clear expectations. The lack of clarity does not stop the FDA from issuing Form 483s regarding these agreements. This workshop will illustrate the content and format of quality agreements and emphasizes important but often overlooked details. Attendees will:
Workshop B Creating Pharmaceutical Supplier Quality Agreements John Vajda, Managing Consultant, BFC Consultants While these contracts are required by regulations and guidance, there are no clearly outlined expectations for them. ICH Q7A 16.12 simply reads “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 party.” Case studies of actual quality agreements will be presented to illustrate how much variation there can be in content and format, to show strengths and weaknesses in the documents, and to illustrate the potential consequences of an inadequate quality agreement. Attendees will:
Register now for the Pre-Congress Workshop. |
Congress 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. |
Michael Gregor, President, Compliance Gurus Inc. Michael Gregor is the president of Compliance Gurus Inc., a premier compliance consulting and software solution provider. Prior to forming his own company, Mr. Gregor acquired over 20 years of experience in the FDA regulated industry. His areas of compliance expertise include: biological, OTC and pharmaceutical drugs, cosmetics, dietary supplements, foods and medical devices. Mr. Gregor has distinguished himself as an industry authority. He has provided compliance guidance to several Fortune 500 companies, which include Pfizer, Schering-Plough, Monsanto, Wyeth and Boston Scientific. In addition, Mr. Gregor has authored several published articles and white papers concerning GCP, GLP and GMP issues. |