Assess Impact For Supplier Change Notices

Schedule Tuesday, August 29, 2023 || 10:00 AM PDT | 01:00 PM EDT

Duration 60 Mins

Level Intermediate

Webinar ID IQW23E0529

What you'll learn?
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Regulatory Expectations

1. FDA
2. ISO

Supplier Agreements

1. Continuing guarantee statements
2. Supplier Change Notices

Assessments of Supplier Change Notices

1. Procedures
2. Team
3. Triage

Types of changes

1. Low/No Impact Changes
2. All other changes
3. How to determine which is which

Full impact assessments of changes which do not fall into the Low/no impact category

1. Level of work based on risk
2. Team approach
3. Tools

Determination of acceptability of change

1. Acceptable change
2. What to do if change is not acceptable

Overview of the webinar

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.

Who should attend?

QA professionals
Technical scientists
Production staff
Regulatory Affairs professionals
Supply chain professionals

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 vendors 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 product.

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 impact on final product, process and/or regulatory impact. This training will highlight ways to assess the impact of supplier changes to help mitigate impact.

Faculty - Mr.Alan M Golden

Alan has over 36 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 26 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 where in 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 management, CAPA, process and test method validation, and statistics. He has been lecturing on these topics worldwide for over 10 years.

Alan retired from Abbott in 2018 and now runs Design Quality Consultants, providing training, workshops, and seminars in many areas of quality assurance.

Alan received his BS degree in Microbiology from the University of Michigan and his MS degree in Molecular Biology and Immunochemistry from the University of Illinois.

Thank you for your interest in becoming a part of our faculty. GRCIQ is continuously looking for excellent individuals from diverse professions to add to our faculty records. Please complete the form below to be considered for our training arrangements in your area of expertise and then submit the form; we will get back as soon as possible.