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 …
Strategic ways to build your professional brand
I-9 Audits: Strengthening Your Immigration Compliance Strat…
Fostering a Culture of Respect: Eliminating Gossip, Rumour…
Excel - Pivot Tables - The Key To Modern Data Analysis and …
Rewiring Your Emotional Triggers: Leading with Clarity and …
AI Fundamentals for All Leaders and Managers: How to Work S…
H-1B Visa Updates and Employer Strategies for 2026
The $1M Mistake: EEOC Discrimination Claims Employers Make …
Using Claude in Excel for Productivity, Automation & Data A…
2-Hour Virtual Seminar on the 6 Most Common Problems in FDA…
2-Hour Virtual Seminar on How to Conduct an Internal Harass…
Bootcamp for New Managers and Supervisors: Develop These Es…
ChatGPT Jumpstart From intro to Download to Personal Assist…
HIPAA Compliance in 2026 — Practical Strategies for Breach …
Do's and Don'ts of Documenting Employee Behaviour, Performa…
Why EBITDA Doesn't Spell Cash Flow and What Does?
Secrets Of Psychology - Why People Do The Things They Do
FDA Regulation of Artificial Intelligence/ Machine Learning
FDA Compliance And Laboratory Computer System Validation
Utilizing HR Metrics to Illustrate & Improve Human Resource…
ChatGPT for CPAs and Finance Professionals
Understanding EBITDA – Definition, Formula & Calculation
The 60 Minutes Introduction to DAX
The Anti-Kickback Statute: Enforcement and Recent Updates
Analytical Method Validation Under Good Laboratory Practice…
Using High-Performance Coaching for Managers to Address Per…
Maximizing Productivity with ChatGPT: AI Solutions for HR, …
Workplace Investigations 101: How to Conduct your Investiga…
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
THE NEW I9 - Mandated Requirements for Worker Verification …
Language is Code - Intro to AI - Generative AI - ChatGPT an…
Discover how Emotional Intelligence turns AI from a technic…
AI in B2B Marketing: What Your Compliance Team Needs to Know
Stress, Change And Team Resilience Through Humor: An Intera…
Effective And Defensible Documentation Of Employee Problems…
How to Write Procedures to Avoid Human Errors