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 …
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
Understanding the incredible uses and fallbacks of ChatGPT
Accounting For Non Accountants : Debit, Credits And Financi…
Project Management for administrative professionals
Coaching At Work- Improving Employee Engagement And Perform…
Gossip-Free: Leadership Techniques to Quell Office Chatter
Excel - Pivot Tables - The Key To Modern Data Analysis and …
Onboarding is Not Orientation: How to Improve Your New Hire…
Using High-Performance Coaching for Managers to Address Per…
21 CFR Part 11 - Compliance for Electronic Records and Sign…
California Meal and Rest Breaks: What You Dont Know Can Cos…
Writing Techniques for Auditors and Risk Management Profess…
Responding to EEOC Discrimination Charges-What's Your Busin…
Conflict Resolution - Prevent, De-escalate, Resolve
Implementing an Effective Human Error Reduction Program
Female to Female Hostility @Workplace: All you Need to Know
With Mandatory Paid Leave Gaining Ground Is It Time To Do A…
When Employees Travel: Wage and Expense Rules Employers Mus…
Validation Statistics for Non-Statisticians
Form 1099-MISC and 1099-NEC Compliance Update 2024
The Totally Organized Professional Is All About Outcomes
GAMP5, Second Edition and Alignment with Computer Software …
Project Management for Non-Project Managers - Scheduling yo…
Why EBITDA Doesn't Spell Cash Flow and What Does
Sunshine Act Reporting - Clarification for Clinical Research
Understanding the Math of HR… So You Can Show How HR Impact…
I-9 Audits: Strengthening Your Immigration Compliance Strat…
FFIEC BSA/AML Examination Manual: What Compliance Officers …
Re-imagine Finance & Accounting Made Simple. Three Webinars…
How to Address ISO's New Climate Change Requirements
How To Conduct An Internal Harassment And Bullying Investig…
Stay Interviews: A Powerful and Low-Cost Employee Engagemen…
Effective Onboarding: How to Welcome, Engage, and Retain Ne…
Managing Toxic & Other Employees Who Have Attitude Issues
Analytical Method Validation Under Good Laboratory Practic…
Do's and Don'ts of Documenting Employee Behaviour, Performa…
Onboarding New Hires: Leverage the Potential of Artificial …
Do's and Don'ts of Giving Effective Feedback for Performanc…
Tattoos, hijabs, piercings, and pink hair: The challenges …
Using Behavior Based Interviewing for Finding the Best Matc…
How to Document Employee Discussions and Why it is Important
Understanding the Artificial Intelligence Landscape
Marketing to Medicare or Medicaid Beneficiaries - What You …
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
Principles & Practices for the Cybersecurity of Legacy Medi…
Independent Contractor vs. Employee New Rule Issued by The …