Managing Your Pharmaceutical Suppliers During COVID-19 – Webinar Recording/Transcript
Has the coronavirus brought chaos to your pharmaceutical supply chain?
Pandemic-induced spot shortages of active pharmaceutical ingredients (APIs) and other materials intensified global supply chain issues, putting additional constraints on a system — and company supply chains — where resources were already limited.
The solution? Focus on your supplier relationships, which are more important than ever.
Take a fresh look at the COVID-affected supply chain — not to mention new and revised ideas about how best to manage the supplier relationship — and you’ll know how to make your suppliers become partners to your success.
Steven Lynn, Executive Vice President of Pharmaceuticals at Regulatory Compliance Associates, Inc. will share the basics of the supplier relationship, emphasizing the best practices you must incorporate to manage it over time.
You’ll come away knowing how to manage problems by tackling them as they arise, conduct pandemic-era supplier audits (how to think about them, prepare for them and execute them) and craft that all-important quality agreement.
- Structure a pharmaceutical supplier agreement that incorporates specific clauses to assist you in monitoring your supplier during the pandemic
- Take advantage of resources limited by COVID-19 within the global supply chain to maintain and/or increase productivity
- Emphasize the basics of the supplier relationship from its beginning, to best practices for managing it over time
- Use new technology to develop best practices for monitoring and overseeing your supplier partnerships
- Conduct world-class supplier audits during the pandemic
- Retain quality oversight in your supplier relationships and deals
Manage your supplier relationships during the pandemic and beyond. You’ll be able to work with them more easily and ensure your products get to market.
Meet Your Presenter
Steven Lynn, Executive Vice President of Pharmaceuticals at Regulatory Compliance Associates, Inc. (RCA), has more than 20 years of quality and regulatory compliance-related experience in the pharmaceutical, biopharmaceutical, medical device, blood, plasma and tissue industries. He is an expert in Current Good Manufacturing Practices (CGMP) compliance-related matters and has significant experience with other GxP quality compliance and regulatory issues. Prior to joining RCA, Mr. Lynn served in executive leadership roles with global accountability in both the private sector and the FDA. Mr. Lynn worked for nearly a decade at the FDA, where he was the Director of the FDA/Center for Drug Evaluation and Research’s (CDER) Office of Manufacturing and Product Quality (OMPQ) within the Office of Compliance (OC). In this role he was responsible for the global CGMP oversight of all drugs manufactured and/or imported into the country to assure compliance with CGMPs. During his last year at the FDA, he served in a dual position as the Operations Transition Lead for CDER’s new Office of Pharmaceutical Quality (OPQ) reporting to CDER’s Center Director, where he was responsible for setting up OPQ operations.
Who Will Benefit
- Quality Assurance/Quality Control Professionals
- Operations Professionals
- Manufacturing Professionals
- Materials Management Professionals
- Purchasing Professionals
- Packaging and Labeling Professionals
- Plant Engineering Professionals
- Laboratory Quality Control Specialists
- Regulatory Affairs Professionals
- Legal Counsel
- Engineering Managers
- Quality Engineers
- Production Engineers
- Purchasing Managers
- Purchasing Agents (involved in outsourcing production or processes)
- Design Engineers
- Project Managers (involved in design and development)
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Dec. 16, 2020