Hear essential expert insights from FDA officials and industry experts during this year’s most important inspections summit. Register today.
FALLS CHURCH, VA. (PRWEB) NOVEMBER 09, 2020
15th Annual FDA Inspections vSummit
An FDAnews Virtual Summit
Tuesday, Nov. 17-Wednesday, Nov. 18, 2020
https://www.fdanews.com/fdainspectionssummitInspections are different amid this global pandemic, but what are the ways to best navigate them now?
There’s no one better to help guide one through these changes than FDA officials and the industry’s most experienced professionals. At the 15th Annual FDA Inspections vSummit on Nov. 17 and 18, experts from around the country will come together to share what they know about the current state of inspections. If one has been wondering how to make it through an upcoming inspection while coping with COVID-19, these sessions and panels are for you.
Attendees will spend this virtual summit with leaders in the drug and device industry going through everything needed to know to successfully navigate an inspection.
During these two days, one will hear from industry experts on timely topics like ensuring GMP inspection readiness, implementing the FDA’s capability maturity model, understanding cybersecurity developments, managing global supply chain issues, determining the future of inspections, managing virtual MDSAP inspections and medical device recalls. Don’t miss these conversations with:
Don Ashley, Director, CDER Compliance
Elizabeth Miller, Pharm.D., Assistant Commissioner Medical Products & Tobacco Operation Office of Regulatory Affairs, FDA
Francisco Vincenty, Program Manager for the Case for Quality, Office of Compliance, Center for Devices and Radiological Health, FDA
Kalah Auchincloss, Senior Vice President, Regulatory Compliance and Deputy General Counsel, Greenleaf Health
Sarah Barkow, Lead GxP External Engagement, Bristol Myers Squibb; former Lead Consumer Safety Officer and Acting Director, Manufacturing Quality Guidance and Policy Staff, CDER, FDA
Seth Carmody, VP, Regulatory Strategy, MedCrypt
David Chesney, Principal and General Manager, DL Chesney Consulting LLC
David Elder, Executive Vice President, Greenleaf Health
Eric Henry, Senior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice, King & Spalding
Connie Hoy, Consultant, Hoy & Associates Regulatory Consulting, LLC
Paula Katz, Special Counsel, Covington & Burling
Julie Larsen, Principal, Director of Inspection Readiness, Teknica Inc.
Beverly Lorell, Senior Medical & Policy Advisor, King & Spalding
Steve Lynn, Principal Consultant/Owner, Lynn Consulting LLC
Steven Niedelman, Lead Quality Systems & Compliance Consultant, King & Spalding LLP
Melanie Power-Burns, Senior Vice President of Quality, Fresenius Kabi
Cynthia Schnedar, Executive Vice President, Regulatory Compliance, Greenleaf Health
Vicky Stoakes, President, IntegRx Inc; former Chemist, ACNA and Investigator, FDA’s Atlanta District Office Drug Cadre
Armin Torres, Principal, Bioteknica
There’s no more effective way to discover the intricacies of this new regulatory world than by mastering it with the industry’s top experts. Join them for sessions dedicated specifically to the interests of drug and devicemakers and get all the details needed to soar through an inspection.
Multi-attendee discounts available!
Significant tuition discounts are available for teams of two or more from the same company.
Virtual Conference Details:
15th Annual FDA Inspections vSummit:
An FDAnews Virtual Summit
Tuesday, Nov. 17-Wednesday, Nov. 18, 2020
https://www.fdanews.com/fdainspectionssummitTuition:
Regular Pricing: $697
Easy Ways to Register:
Online: https://www.fdanews.com/fdainspectionssummit
By phone: 888.838.5578 or 703.538.7600
About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations
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