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 …
ChatGPT and Project Management: Leveraging AI for Project M…
I-9 Audits: Strengthening Your Immigration Compliance Strat…
Handbook Overhaul 2026: Compliance, OBBB Act & Beyond
Practice Safe Stress ™: Preventing Burnout While Building R…
Rewiring Your Emotional Triggers: Leading with Clarity and …
AI, Jobs, and Skills: How HR Leaders Can Prepare Now for th…
The Age-Inclusive Workplace: How to Lead and Work Across Ge…
Pivot tables beginner to advanced + 20 advanced Pivot table…
Writing Effective Job Descriptions
HR Metrics and Analytics 2026- Update on Strategic Planning…
High-Impact Performance Management: Tools, Tactics & Coachi…
Validation Statistics for Non-Statisticians
Batch Record Review and Product Release
Human Factors Usability Studies Following ISO 62366 and FDA…
Best Practices for FDA Computer System Audit Preparation in…
Fire Without Fear: How to Legally Terminate an Employee
FDA Regulation of Artificial Intelligence/ Machine Learning
Empowering Conflict Resolution: Letting Go to Gain Control
The Importance of the first 5 seconds when presenting
Burnout to Fired-up : Recognizing and Preventing Burnout in…
Do's and Don'ts of Giving Effective Feedback for Performanc…
Managing Toxic & Other Employees Who Have Attitude Issues
Reduce Stress in the Workplace: Effective Ways to Handle Co…
Better Mind, Better Life: Unlocking Your Full Potential
2-Hour Virtual Seminar on the 6 Most Common Problems in FDA…
Why EBITDA Doesn't Spell Cash Flow and What Does?
Fostering a Culture of Respect: Eliminating Gossip, Rumour…
Human Error Trends as AI Enters GMP Operations: What QA Lea…