Overview
In light of the COVID-19 pandemic, unanticipated supply chain disruptions and postponed FDA inspections have created significant risks and challenges for the global medical product manufacturing network. The recently enacted CARES Act and new FDA guidance have established a new framework for addressing supply chain disruptions through formal risk management plans. In this webinar, presenters will discuss regulatory requirements as well as strategies for developing a post-Coronavirus recovery action plan, how to implement and manage an effective plan, and how to be prepared for an establishment inspection, whether through record reviews or during on-site inspections post-crisis.
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Speakers
Daniel Barreto, President and CEO, PharmQ Global Consulting
Cathy L. Burgess, Partner, Alston & Bird LLP and Member, FDLI Board of Directors
Joseph Jimenez, Managing Director, Arches Consulting, LLC
Moderated by Robert A. Rhoades, Managing Partner, Validant
DAN BARRETO is the President and CEO of PharmQ Global Consulting, a company that provides a comprehensive set of supporting, coaching, mentoring, and assessment expertise to the global pharmaceutical industry. His expertise is based on over 40 years of combined FDA and regulated industry experience. With the US Food and Drug Administration he performed hundreds of complex inspections and investigations involving products and processes associated with solid forms as well as aseptically-filled products, including combination drug/device products. Dan is the first FDA investigator who performed the first criminal investigation leading to the 1988 wider FDA Generic Drug Scandal investigation. Since he left the FDA in 1996, he has worked with innovator, generic, and combination drug/device companies in Europe, working in Belgium with Johnson and Johnson, and in Germany with SANOFI Frankfurt. His exposure to worldwide activities included working with international manufacturing partners while also addressing inquiries and regulatory matters with influential regulators. His domestic pharmaceutical and medical device experience in the US are based on working for Medeva Pharmaceuticals, Teva Pharmaceuticals, and CR Bard, Inc.
JOSEPH JIMENEZ is the Managing Director of Arches Consulting, LLC., focused on developing and executing strategies for the pragmatic application of regulatory compliance in pharmaceutical, medical device, human tissue and OTC healthcare organizations. Leading change of the compliance culture for dynamic organizations across major international regulatory markets, he assists clients optimize their regulatory profile. Mr. Jimenez has led Quality organizations in large (TEVA, PGT, IVAX) and small (TTI), companies, held global, regional and site-based roles, through compliance remediation, growth and reorganization, while supporting due diligence efforts for business development, acquisition and joint ventures. He is based in South Florida.
BOB RHOADES is Managing Partner at Validant. Throughout his 42-year career, Mr. Rhoades has been a preferred advisor to senior pharmaceutical and medical device executives seeking counsel on compliance and its impact on corporate direction and business strategy. A skilled practitioner of both the Quality System Regulation (QSR) and the pharmaceutical cGMPs, he has designed and implemented compliance improvement initiatives for manufacturers in the US, Europe, India and China. He frequently provides post-Warning-Letter guidance and remediation project management to re-establish client credibility with the FDA. In addition, he assists manufacturers in proactively designing and optimizing quality systems. Mr. Rhoades often works in concert with client counsel on a wide variety of legal cases. He was selected by client counsel to advise in the contaminated heparin crisis that reached global proportions in 2008, and has provided third-party expert services in several Consent Decree cases for several multi-national companies, both pharma and medical device. Prior to joining Validant, he led the Quality & Compliance Consulting Practice at Quintiles for more than 7 years. Prior to Quintiles, Bob held various Quality leadership roles for Solvay Pharmaceuticals, Bausch & Lomb and Baxter Healthcare. He holds a Masters of Business Administration in Operations Management and Strategic Planning from Lake Forest Graduate School of Management and a Bachelor of Science degree in Microbiology from Purdue University.Virtual Learning FAQ
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