Supplier Quality Management CongressAssuring the Integrity of Drug and Device Raw Materials and Supply Chains
Product Details
The FDA has put additional focus on "corporate responsibility" for supply-chain management. And FDA and Justice Department attorneys are warning that they are considering pushing strict liability cases harder to get executives to accept that responsibility.
Some lawyers think the FDA will almost certainly require more specific record-keeping for supply-chain issues, including third-party certification requirements all the way up the line to final manufacturing. Will this be another Sarbanes-Oxley regulation nightmare?
We're responding to these issues on your behalf the best way we know how — by inviting top FDA officials to speak directly to you.
Because of the divergence between drug and device issues, we've split this conference into a drug track and a device track for maximum benefit to all attendees.
John Avellanet,
Chair
John Avellanet
is a former medical device and biopharma executive who created,
developed and ran a Fortune 50 subsidiary's records management and
IT 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. |
Costas Chantzis,
Chair Costas Chantzis is founder and president of TechnoBusiness Solutions, providing macro and micro regulatory compliance and operational excellence solutions to clients in device, pharmaceutical and biotechnology firms. Costas is known worldwide for his many conference chairmanships and speaking engagements. He has held positions in R&D, new business development, validation/regulatory compliance and operational excellence at Vacutainer Systems and AcuteCare divisions of Becton Dickinson, Schering- Plough, and VTS. |
Distinguished Faculty
Barry Rothman |
Kimberly Trautman Medical Device Quality System Expert Office of Compliance CDRH, FDA |
Congress Faculty
Cynthia Ely Supplier Quality Management Amgen |
Jackie Torfin Director of Quality Arizant Healthcare |
Jim Shore Principal Design Assurance Engineer Boston Scientific |
Mike Fedock Senior Supply Quality Engineer St. Jude Medical |
Steve McKenna Senior Quality Manager Boston Scientific |
Ryan Sproul Supplier Quality Engineer Gyrus Medical — An Olympus Company |
Steve Niedelman Senior Consultant Crowell & Moring |
Parag Jhaveri Senior Quality Management Engineer Becton Dickinson |
Ruth Barnett Former Quality Assurance Director Ethicon-J&J |
Conference attendees will:
- Analyze and compare case studies of three actual quality agreements, illustrating the degree of variation, strengths and weaknesses of each
- Learn how to use the process flow diagram to identify critical control points and tasks that need to be addressed in the quality agreement
- Learn CDER’s perspective on supplier quality and compliance outlook
- Learn to utilize risk assessment to manage OEM/CMO suppliers
- Discover how to convert supplier quality-related CAPA challenges into tangible benefits and competitive advantage
- Examine Amgen's China supplier strategic plan
- Learn to overcome customer-supplier barriers to promote effective relationships
- Learn about leveraging supplier audits throughout a global organization
- And much, much more!
Bonus
Pre-Conference Afternoon Workshop
A quality agreement is a written contract between client and
supplier delineating responsibilities and quality expectations in advance
of and in addition to the supply agreement. It is intended to prevent
critical details from "falling through the cracks."
While these contracts are required by regulations and guidance, expectations for them are not clear. Instructions in both ICH Q7A 16.12 and the FDA Globalization Act are vague. But lack of clear agency expectations does not preclude 483 observations regarding the quality agreement.
This special workshop will examine the content and format of quality agreements, emphasizing important but often-overlooked details. Tools to build a document that addresses both parties' expectations will be discussed. Case studies of actual quality agreements will be presented to illustrate variation in content and format; show strengths and weaknesses; and illustrate consequences of an inadequate quality agreement.
Attendees will:
- Employ the prospective source audit report and EIRs to determine what areas of the Quality Agreement need particular attention.
- Learn how to use the process flow diagram to identify Critical Control Points and tasks that need to be addressed in the Quality Agreement.
- Learn the critical importance of a Definitions section — why one person's batch record is another person's data sheet.
- Discover how to avoid potential quality problems by identifying and addressing them in advance.
- Specify operational expectations within the limits of each party's capabilities — making sure each party can do what is expected/needed/wanted.
- Learn special considerations for Quality Agreements with ex-U.S. CMOs — "Never expect to start a campaign in August."
- Incorporate Quality Risk Management requirements into the Quality Agreement, in accord with the FDA Globalization Act of 2009.
- Analyze and compare case studies of three actual quality agreements, illustrating the degree of variation, strengths and weaknesses of each.