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Live Webinar

60-minute live streaming program
  • October 6
  • 1:00 - 2:00 pm EST

FDA Expectations of Supplier and Service Provider Controls

October 6

Learn how you can meet your obligations, reduce compliance risk, and take advantage of some likely new financial incentives.

Over the last decade, Congress and the Food and Drug Administration have recognized the challenges of overseeing complex pharmaceutical supply chains. As inputs to drugs have become more globalized and issues with quality and reliability have arisen, the agency has sought and used new enforcement tools to incentivize drug manufacturers to more carefully scrutinize supply chains. The added attention has created compliance risks and challenges - whether for getting a drug approved, post-market compliance, or evaluating drug companies for acquisitions. This topic will describe these risks and suggests ways in which companies can manage and minimize risk. It outlines the history of supply chain regulation, from statutory changes in 2012 to the CARES Act of 2020. It also examines current FDA initiatives, upcoming Biden Administration actions, and possible legislation. It also discusses the European and Chinese regulatory approach to supply chain oversight. Finally, the information suggests steps companies can take to meet their obligations and reduce compliance risk and to take advantage of some likely new financial incentives.

Learning Objectives

  • You will be able to describe the regulatory expectations for oversight over pharmaceutical supply chains.
  • You will be able to discuss the evolving policy landscape regarding supply chains and how it affects stakeholders.
  • You will be able to explain how to minimize risk from supply chain oversight and take advantage of possible opportunities from pharmaceutical onshoring.
  • You will be able to identify the risks for your company from supply chain oversight.

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Why Lorman?

Over 34 years and 1.4 million customers worth of experience providing continuing education. Our passion is providing you world-class training to help you succeed in business and as a professional.

Agenda

Historical Overview of Supply Chain Oversight
  • FDA Safety and Innovation Act
  • Recent FDA Initiatives
  • Recent FDA Enforcement
Post-COVID-19 Emphasis on Supply Chains
  • COVID-19 Supply Chain Problems
  • CARES Act and Its Implications
  • Biden-Harris Supply Chain Initiatives
Foreign Perspective
  • European Regulation
  • Chinese Regulation
Supply Chain Oversight Best Practices
  • Enterprise Supply Chain Risk Assessment
  • Transactional and Securities Implications
  • Preparing for Pharmaceutical Onshoring
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More Program Information

Why Lorman?

Over 34 years and 1.4 million customers worth of experience providing continuing education. Our passion is providing you world-class training to help you succeed in business and as a professional.

Credits

Live Webinar Registration

  • CPIM/CFPIM/CSCP 1.0
     
  • This program may qualify for 1.0 certification maintenance points toward the CSCP, CPIM and CLTD designations through The Association for Operations Management.
     
  • ISM 1.0
     
  • Participants who successfully complete this program will receive 1.0 hours of continuing education. They may be applied toward ISM CPSM, CPSD or C.P.M. recertification. ISM's consent to approve hours for this educational event is not an endorsement of this program or its content by ISM.
     
  • CPE 1.2 including Production 1.2
     
  • Lorman Education Services is registered with the National Association of State Boards of Accountancy (NASBA) as a sponsor of continuing professional education on the National Registry of CPE Sponsors. State boards of accountancy have final authority on the acceptance of individual courses for CPE credit. Complaints regarding registered sponsors may be submitted to the National Registry of CPE Sponsors through its web site: www.nasbaregistry.org. For more information regarding administrative policies such as complaint and refund, please contact our offices at 866-352-9539. CPE Credit: Maximum Credit Hours: 1.2 each session (based on a 50 minute credit hour). You must attend at least 50 minutes to obtain credit. Field of Study: Production for 1.2 hours. Prerequisite: . Level of Knowledge: Intermediate. Teaching Method: Seminar/Lecture. Advance Preparation: None. Delivery Method: Group Internet Based. Please refer to the information in this brochure for outline, course content and objectives. Upon completion of this course, you will receive a certificate of attendance. Final approval of a course for CPE credit belongs with each state's regulatory board. Please note: In order to receive CPE credit for this course you MUST use the streaming audio option, as well as enable and complete the required progress checks.
     

Who should attend?

This live webinar is designed for purchasing and procurement professionals, buyers, material managers, contract administrators, project managers, controllers, accountants, and bookkeepers.

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Why Lorman?

Over 34 years and 1.4 million customers worth of experience providing continuing education. Our passion is providing you world-class training to help you succeed in business and as a professional.

Faculty

Howard Sklamberg

Howard Sklamberg

Arnold & Porter Kaye Scholer LLP

  • Partner in Arnold & Porter Kaye Scholer LLP’s Life Sciences and Healthcare Practice, focusing on FDA regulation
  • Practice includes advising on inspections and compliance actions, clinical trials, pre-market applications, investigations, and transactions involving FDA regulatory and enforcement issues
  • Senior official in FDA from 2010-2017, including Deputy Commissioner for Global Regulatory Operations and Policy and Director of the Office of Compliance for the Center for Drug Evaluation and Research
  • Can be contacted at 202-942-5075 or [email protected]
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Why Lorman?

Over 34 years and 1.4 million customers worth of experience providing continuing education. Our passion is providing you world-class training to help you succeed in business and as a professional.

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Product ID: 405547
Published 2021
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