This webinar will present strategies and tools for doing a complete and comprehensive impact assessment of supplier change notices. Tools and procedures for deciding if full impact assessments need to be processed and when notices for lower impact changes can be accepted or rejected without a full assessment will be discussed. Who (what skill sets) should be on the impact assessment team, how often to meet and methods for evaluating change notices will also be discussed. Supplier agreements and quality agreements with suppliers and vendors as well as using risk based approaches to impact assessments will be highlighted.
Any manufacturer of pharmaceutical products or medical devices will have vendors and suppliers in order to acquire the materials needed for manufacturing product. In a regulated environment, the manufacturer is responsible for the quality and source of all incoming materials. When supplier or vendors make changes to material, its own manufacturing or supplier they should tell the manufacturer about these changes via a supplier change notice. Without proper evaluation of the change, unforeseen changes could occur in the product leading to failed manufacturing runs or the release of non-conforming material to market. Regulatory agencies (FDA) expect manufactures to be in control of all incoming material, therefore failure to do a proper impact assessment of supplier changes could also lead to enforcement action and/or product recall. Manufactures need a robust process ensure all vendors and suppliers provide change notices and to evaluate all notices for impact.
Any manufacturer of pharmaceutical products or medical devices will have vendors and suppliers in order to acquire the materials needed for manufacturing product. In a regulated environment, the manufacturer is responsible for the quality and source of all incoming materials. When supplier or vendors make changes to material, its own manufacturing or supplier they should tell the manufacturer about these changes via a supplier change notice. Without proper evaluation of the change, unforeseen changes could occur in the product leading to failed manufacturing runs or the release of non-conforming material to market. Regulatory agencies (FDA) expect manufactures to be in control of all incoming material, therefore failure to do a proper impact assessment of supplier changes could also lead to enforcement action and/or product recall. Manufactures need a robust process ensure all vendors and suppliers provide change notices and to evaluate all notices for impact.
Alan M Golden
Alan M Golden has over 30 years of experience in the medical device industry, both in basic research and quality assurance. Alan spent 31 years at Abbott Laboratories. For the first 16 years as part of diagnostics R&D, he developed recombinant proteins used in diagnostics tests, received three US patents, and published numerous papers and abstracts. Alan then transitioned to a quality assurance role wherein both the Abbott Diagnostics and Abbott Molecular divisions, he was responsible for quality assurance for new product development, on-market product support, and operations.Alan’s quality assurance experience extends from design control, change control, risk …
Managing Difficult Employee Conversations
Handbook Overhaul 2026: Compliance, OBBB Act & Beyond
Independent Contractor vs. Employee - 2026 IRS Guidance on …
ChatGPT for HR - Build HR Policy Framework and Strategy
Stop Conflicts Before They Become Big Problems: Practical S…
Virtual and In-Person Onboarding Your New Hire: Policies, P…
Major Changes in W2 and 1099 for 2026 Compliance! Learn How…
Setting SMART Goals & Leveraging Storytelling for Reporting
Female to Female Hostility @Workplace: All you Need to Know
I-9 Audits: Strengthening Your Immigration Compliance Strat…
Rewiring Your Emotional Triggers: Leading with Clarity and …
From Spreadsheet Logic to Analytics Logic: Excel → Power BI…
Electronic Payment Fraud Prevention Best Practice
Onboarding Best Practices for Millennial and All Employees
Mastering the Prompt: How Every Professional Can Use AI to …
Batch Record Review and Product Release
Emotional Intelligence: Mastering the Emotions of Great Lea…
Managing Toxic & Other Employees Who Have Attitude Issues
FDA QMSR Explained: How the QMSR Replaces the QSR
2-Hour Virtual Seminar on How to Conduct an Internal Harass…
Project Management for Non-Project Managers - How to commun…
ChatGPT for CPAs and Finance Professionals
Leading a Project and Team in Stressful Times: Supporting y…
Excel - Pivot Tables - The Key To Modern Data Analysis and …
Better Business Writing-How to Write Right
HR Metrics and Analytics 2026- Update on Strategic Planning…
Excel + AI: The Smart User's Guide to Faster, Easier Work w…
4-Hour Virtual Seminar on Secrets of Psychology - Why Peopl…
Accounting For Non Accountants : Debit, Credits And Financi…
Thriving in a Hybrid Workplace: Keys to Leadership and Team…
Conquer Toxic People - Learn To Protect Yourself And Get Yo…
Data Integrity and Privacy - Compliance with 21 CFR Part 11…
FDA Regulation of Artificial Intelligence/ Machine Learning
H-1B Visa Updates and Employer Strategies for 2026
Beyond Orientation: Build a Strategic Onboarding Experience…
Modern Change Management: A Human-Centered System for Drivi…