Overview
Inspections are a critical component of FDA’s enforcement authorities to ensure compliance with FDA rules and regulations and COVID has caused the inspections process to only become more complicated. Properly preparing the facility, documentation, and staff in advance of an inspection is vital for success. In this webinar, experts will discuss best practices for assessing vulnerabilities and strengths, preparing subject matter experts, and planning for documentation. They will also discuss FDA’s newly released draft guidance, Conducting Remote Regulatory Assessments: Questions and Answers, the specific challenges of remote workforces, and the potential of remote interactive evaluations.
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Speakers
Cathy L. Burgess, Partner, Alston & Bird LLP and Member, FDLI Board of Directors
David L. Chesney, Principal and GM, DL Chesney Consulting, LLC
Christopher Fanelli, Partner, Sidley Austin LLP
Moderated by Bob A. Rhoades, Managing Partner, Validant
Additional speakers pending
CATHY L. BURGESS is a partner at the law firm of Alston & Bird, LLP in Washington, D.C., and serves as the co-chair of the firm’s FDA Practice. Her practice focuses primarily on regulatory compliance, product and supply chain risk management, enforcement, and policy matters related to CGMP and QSR regulation of global manufacturers. Burgess provides strategic counseling, conducts internal investigations and special audits related to FDA compliance, and assists clients in designing compliance programs, internal audit programs, and other risk mitigation strategies. She is recognized as a leading practitioner for life sciences, food and beverage law, and in the area of pharmaceutical and medical products regulation. Burgess previously served as associate general counsel for the American Red Cross, where she was responsible for regulatory matters; providing legal and strategic advice to Red Cross senior management and the board of governors’ Audit Committee on matters related to the Red Cross Amended Consent Decree. She also previously served as the defense team’s first chair for expert testimony on CGMPs and analytical method validation in United States v. Barr Laboratories, widely recognized as the leading case on CGMPs. Burgess earned her JD from The Catholic University of America and a BSFS from Georgetown University.
DAVID L. CHESNEY is the Principal and General Manager for DL Chesney Consulting, LLC, providing GMP and GCP compliance consulting and training services to clients worldwide. Previously he served for over twenty years as Vice President, Strategic Compliance Services for PAREXEL Consulting. Prior to joining PAREXEL Consulting, he served twenty-three years with the FDA as an Investigator, Supervisory Investigator, Director of Investigations, and ultimately as District Director in San Francisco, managing all FDA operations in Northern California, Nevada, and Hawaii. Chesney holds an MS in Jurisprudence, concentrating in Pharmaceutical and Medical Device Law, from Seton Hall University School of Law, a Bachelor’s degree in Biology from California State University, Northridge, plus three years of graduate study in Biology at CSU Northridge and CSU San Diego. Chesney is a member of the Parenteral Drug Association, where he serves on the faculty of the PDA Training and Research Institute. He serves as a Guest Lecturer for the Maine Regulatory and Ethics Training Center, University of Maine School of Law, and is also active in the Food and Drug Law Institute and RAPS.
ROBERT A. (BOB) RHOADES is Managing Partner at Validant. Throughout his 42-year career, 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. 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, he 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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