This webinar will discuss dealing with supplier change notices. Regulatory agencies have the expectation that a manufacturer has control over its supply chain and dealing with changes to that supply chain can be challenging.
WHY SHOULD YOU ATTEND?
Companies in the pharmaceutical and medical device space are required to have control over their supply chain and suppliers. Suppliers make changes to their product, production, or location on a routine basis. The manufacturer needs to assess the impact of those changes on their product and or production before introducing the vendor's product into their manufacturing process. This webinar will discuss setting up good supplier agreements so change notifications are received and how to do a proper impact assessment of those notices before accepting altered products.
All companies in the pharmaceutical and medical device space are required to have control over their supply chain and suppliers. Inadequate assessment of changes to supplier material, production, or location can have an impact on the final product, process, and/or regulatory impact. This training will highlight ways to assess the impact of supplier changes to help mitigate the impact.
AREA COVERED
Regulatory Expectations
- FDA
- ISO
Supplier Agreements
- Continuing guarantee statements
- Supplier Change Notices
Assessments of Supplier Change Notices
- Procedures
- Team
- Triage
Types of changes
- Low/No Impact Changes
- All other changes
- How to determine which is which
Full impact assessments of changes that do not fall into the Low/no impact category
- Level of work based on risk
- Team approach
- Tools
Determination of acceptability of change
- Acceptable change
- What to do if the change is not acceptable
WHO WILL BENEFIT?
- QA professionals
- Technical scientists
- Production staff
- Regulatory Affairs professionals
- Supply chain professionals
Companies in the pharmaceutical and medical device space are required to have control over their supply chain and suppliers. Suppliers make changes to their product, production, or location on a routine basis. The manufacturer needs to assess the impact of those changes on their product and or production before introducing the vendor's product into their manufacturing process. This webinar will discuss setting up good supplier agreements so change notifications are received and how to do a proper impact assessment of those notices before accepting altered products.
All companies in the pharmaceutical and medical device space are required to have control over their supply chain and suppliers. Inadequate assessment of changes to supplier material, production, or location can have an impact on the final product, process, and/or regulatory impact. This training will highlight ways to assess the impact of supplier changes to help mitigate the impact.
Regulatory Expectations
- FDA
- ISO
Supplier Agreements
- Continuing guarantee statements
- Supplier Change Notices
Assessments of Supplier Change Notices
- Procedures
- Team
- Triage
Types of changes
- Low/No Impact Changes
- All other changes
- How to determine which is which
Full impact assessments of changes that do not fall into the Low/no impact category
- Level of work based on risk
- Team approach
- Tools
Determination of acceptability of change
- Acceptable change
- What to do if the change is not acceptable
- QA professionals
- Technical scientists
- Production staff
- Regulatory Affairs professionals
- Supply chain professionals
Speaker Profile

Alan M Golden has over 30 years of experience in the medical device industry, both in basic research and in 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, …
Upcoming Webinars

Essential Metrics to Measure Accounts Receivable Health

Bad Standard Operating Procedures (SOPs) - Bad Training: Ga…


Three Key Risk Assessments in Your ERM Program - ERM IT and…

HR Metrics & Analytics 2022: Update on Strategic Planning, …

Recent UPDATES to the Rules Stop Payments vs Unauthorized E…

Financial Projections for Determining Long-Term Cash Flow R…

Data Modelling and Analysis with Excel Power Pivot


Impact Assessments For Supplier Change Notices

How to Write Contracts for Procurement Professionals

FDA Regulation of Artificial Intelligence/ Machine Learning

Stay Interviews: A Powerful Engagement and Retention Tool



Harassment, Bullying, Gossip, Confrontational and Disruptiv…





FORM I-9 2022: ICE Announces New Extension Date and Require…

Establishing a Robust Supplier Management Program

Travel and Expense Policy Development and Automation

With Mandatory Paid Leave Gaining Ground, Is It Time To Do …

Project Management for Non-Project Managers



Implementing an Effective Human Error Reduction Program

How to prepare an effective audit manual for an internal au…

CMO Supplier Quality Agreements: How to Comply with new FDA…


Form 1099 Update 2022: Latest Forms, Rules and Reporting Re…

21 CFR Part 11 - Compliance for Electronic Records and Sign…

Managing Toxic & Other Employees Who have Attitude Issues

The Importance of Packaging and Labeling in Pharmaceutical …

I-9 Audits: Strengthening Your Immigration Compliance Strat…


The Top Ten Excel Functions Everyone Should Know