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
Managing Toxic & Other Employees Who Have Attitude Issues
Effective Onboarding: How to Welcome, Engage, and Retain Ne…
Analytical Method Validation Under Good Laboratory Practic…
Do's and Don'ts of Documenting Employee Behaviour, Performa…
Sunshine Act Reporting - Clarification for Clinical Research
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
Project Management for HR, Administrative Professionals, an…
Stressed Out: How to Handle Conflict, Difficult People and …
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
Marketing to Medicare or Medicaid Beneficiaries - What You …
Understanding the Artificial Intelligence Landscape
Best Practices for Working With Vendors and Suppliers
Accounting For Non Accountants : Debit, Credits And Financi…
Principles & Practices for the Cybersecurity of Legacy Medi…
Independent Contractor vs. Employee New Rule Issued by The …
The Top Ten Excel Functions Everyone Should Know
Ultimate Persuasion Strategies! - Secret Influence Tools & …
Clinical Trial Systems: The Trial Master File (TMF) and Ele…
Dealing With Difficult People In Life & Work
Improving Employee Engagement & Retention Through Stay Inte…
Fair Lending in Q2 2024: new regulations, examinations, and…
FDA Regulation of Artificial Intelligence/ Machine Learning
Form 1099 Update 2024: Latest Forms, Rules and Reporting Re…
Coming Soon - New Minimum Salary Levels for Exempt Employee…
Beyond ‘Illegal’ Interview Questions: What Recruiters & Hir…
Bootcamp for New Managers and Supervisors: Avoid These 7 Mi…
Writing Techniques for Auditors and Risk Management Profess…
Coaching & Retaining Your Talent – Putting the WOW into Qua…
Outlook - Master your Mailbox - Inbox Hero Inbox Zero
Emotional Intelligence: Mastering the Emotions of Great Lea…
Building Fair Chance Hiring Policies in 2024
Effectively Handle Toxic People for Better Productivity and…
Third-Party Relationships: Risk Management: What All Bankin…
HR 101 - Bootcamp Basics for New Human Resource Professiona…
How to Manage and Resolve Conflict in the Workplace
Impact Assessments For Supplier Change Notices
Performance Management with Bottom-Line Results
How to Give Corrective Feedback: The CARE Model - Eliminati…
Human Error Reduction Techniques for Floor Supervisors
Credit Risk Discipline Tools - Implementing 14 Tools for Cr…
FDA Compliance And Laboratory Computer System Validation