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 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 …
Upcoming Webinars

Contractor vs Employee: How to Tell the Difference and What…

Imposter Syndrome: How to Define, Understand & Shift Your E…

FDA current recommendations related to timely initiation of…


Impact Assessments For Supplier Change Notices

Implicit Bias: Becoming Aware of Your Inner Storyteller

Complying with the NEW I-9 and E-Verify Regulations - The I…

The Federal Anti-Kickback Statute & Stark Law: What Physici…

Building an Effective Injury Management Process

Fatal Errors Employers Make When Updating Employee Handbook…

Understanding the Changes Coming to NCCI's Experience Mod i…

From Awareness to Action: Going Beyond the Law in Preventin…

Onboarding is NOT Orientation - How to Improve the New Empl…


From Awareness to Action: Going Beyond the Law in Preventin…


FDA Compliance and Clinical Trial Computer System Validation

5 Proven Ways To Engage & Retain Your Team Even During The …


Customer Relationship Management: Strategic Methods to Mana…

Navigating New Paths: Unveiling Your Unique Abilities for a…

Form 1099 Update 2023: Latest Forms, Rules and Reporting Re…

Strategic Interviewing & Selection: Getting the Right Talen…



Project Management for Non-Project Managers - How to Effect…

Implementing a Robust Change Control Program - Key Elements…

Amazing (!) AI Tools For Building Your Business



Excel - Unleashing the Full Potential of New Functions (Exc…

How to Conduct Annual Product Reviews to Achieve GMP Compli…



What Business Leaders Need to Know About Cybersecurity Prep…

Responding to EEOC Discrimination Charges-What's Your Busin…

Harassment, Bullying, Gossip, Confrontational and Disruptiv…