How to Manage Supplier Risk – Archived Presentation by John Avellanet
October 12th, 2011 // 12:39 pm @ jmpickett
John Avellanet of Cerulean Associates LLC, presents a risk-based, cost-conscious approach to supplier selection, oversight and management. John is an an internationally acknowledged expert, speaker and syndicated author on lean regulatory compliance, preventing intellectual property theft and quality by design.
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Note: You can contact John by phone or email after the Webinar for your follow up questions.
Summary:
Under the new FDAAA of 2007, the US Congress authorized the FDA to fine individual executives $16,500 for each violation (e.g., 483 finding); this is in addition to multi-million dollar fines levied on the corporation as a whole. Given FDA’s stated intent to dramatically intensify supplier scrutiny and vendor oversight, selection and qualification of your vendors is absolutely crucial to both your quality program and your wallet.
This presentation reveals a successful roadmap to implement a component of lean compliance, effectively integrating risk management and cost-effectiveness as part of an approach to vendor selection and oversight. It will focus on how to design a strategy for lean supplier selection, effectively share the regulatory compliance risk, and ensure consistent vendor accountability.
Based on years of work with clients ranging from biopharmaceutical companies and start-up medical device firms, plus his own experiences as a device and biotech executive, Mr. Avellanet will show you how to improve your vendor management program to improve compliance, lower cost and minimize risk.
Components of the webinar will also discuss recent FDA expectations toward managing vendors, suppliers and contractors, and provide insights to achieve compliance.
What You Will Learn:
– Effective strategy for selecting suppliers
– Tactics to share the compliance burden and regulatory risk
– A systematic methodology to ensure vendor accountability
– The challenges in vendor management
– Different categories of suppliers
– What the FDA will be looking for when it comes to vendor management
– Organizational considerations in implementing a vendor management system
– The benefits of pursuing a lean supplier strategy
Order Now! Save $50 Off Regular Price ($349)
Same Day Download! CD Also Available at No Extra Cost!
About the Speaker:
Cerulean’s John Avellanet is an internationally renowned speaker, expert and authority on lean compliance practices and FDA cGMP, GLP, QSR, 21 CFR Part 11, ICH and GHTF.
He has trained FDA and Health Canada officials, spent over 15 years personally accountable for regulatory compliance, and has passed multiple regulatory inspections. He was personally trained by the authors of 21 CFR 11 to conduct FDA inspections himself. Mr. Avellanet has been called been called “the best in the business” by former FDA and Department of Justice officials.
Trusted by officials at FDA, NIH and the OIG, as well as by clients around the world, Mr. Avellanet provides practical, business-savvy solutions to strengthen compliance while lowering costs and reducing risk. He speaks frequently at industry conferences and organizations around the world.
Recent awards
Best of Business – Small Business Commerce Association
Top 10 FDA Compliance Blogs – FDAzilla Editors and Readers Choice
Top 50 Pharma / Biotech Blog – Biotechnology Graduate Students Association
Lifetime Achievement – Who’s Who of Pharmaceutical & Device Executives
He founded Cerulean in 2006, and today is an internationally acknowledged expert, speaker and syndicated author on lean FDA compliance .
Mr. Avellanet’s most recent book, Get to Market Now! Turn FDA Compliance into a Competitive Edge, was featured at BIO 2011. He is a contributing author to the book Best Practices in Biotechnology Business Development, and publishes the monthly newsletter of quality systems tips and regulatory intelligence, SmarterCompliance.
Throughout his corporate career, Mr. Avellanet has been personally accountable for regulatory compliance and quality systems (including ICH, GHTF, FDA Parts 820 and 11), records management, and IT compliance.
Mr. Avellanet’s regulatory and quality expertise is based primarily on his experiences having to put in place, live under, and be audited upon various rules and regulations. He has since translated his mistakes and successes into client success stories – whether setting up flexible, risk-based GLP/GMP quality systems, putting in defensible document and record retention programs, conducting mock FDA audits, or helping companies recover from FDA inspections and warning letters.
