This webinar will present strategies and tools for doing a complete and comprehensive impact assessment of supplier change notices. Tools and procedures for deciding if full impact assessments need to be processed and when notices for lower impact changes can be accepted or rejected without a full assessment will be discussed. Who (what skill sets) should be on the impact assessment team, how often to meet and methods for evaluating change notices will also be discussed. Supplier agreements and quality agreements with suppliers and vendors as well as using risk based approaches to impact assessments will be highlighted.
Any manufacturer of pharmaceutical products or medical devices will have vendors and suppliers in order to acquire the materials needed for manufacturing product. In a regulated environment, the manufacturer is responsible for the quality and source of all incoming materials. When supplier or vendors make changes to material, its own manufacturing or supplier they should tell the manufacturer about these changes via a supplier change notice. Without proper evaluation of the change, unforeseen changes could occur in the product leading to failed manufacturing runs or the release of non-conforming material to market. Regulatory agencies (FDA) expect manufactures to be in control of all incoming material, therefore failure to do a proper impact assessment of supplier changes could also lead to enforcement action and/or product recall. Manufactures need a robust process ensure all vendors and suppliers provide change notices and to evaluate all notices for impact.
Any manufacturer of pharmaceutical products or medical devices will have vendors and suppliers in order to acquire the materials needed for manufacturing product. In a regulated environment, the manufacturer is responsible for the quality and source of all incoming materials. When supplier or vendors make changes to material, its own manufacturing or supplier they should tell the manufacturer about these changes via a supplier change notice. Without proper evaluation of the change, unforeseen changes could occur in the product leading to failed manufacturing runs or the release of non-conforming material to market. Regulatory agencies (FDA) expect manufactures to be in control of all incoming material, therefore failure to do a proper impact assessment of supplier changes could also lead to enforcement action and/or product recall. Manufactures need a robust process ensure all vendors and suppliers provide change notices and to evaluate all notices for impact.
Alan M Golden
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 …
Aligning Your HR Strategy with Your Business Strategy
Accounting For Non Accountants : Debit, Credits And Financi…
Developing an FDA/ISO Compliant Quality Management System
I-9 Audits: Strengthening Your Immigration Compliance Strat…
Dealing With Difficult People In Life & Work
Managing Difficult Employee Conversations
Predictive Accounting: Driver-Based Budgeting And Rolling F…
Pay Equity Changes for 2024! What Employers Need to Know to…
Leader Branding: How to Communicate with Confidence to Attr…
FFIEC BSA/AML Examination Manual: What Compliance Officers …
Why EBITDA Doesn't Spell Cash Flow and What Does
Design Verification, Validation and Testing for Medical Dev…
Project Management for Non-Project Managers - How to commun…
Data Integrity and Privacy: Compliance with 21 CFR Part 11,…
Employee or Independent Contractor – U.S DOL Announces 2024…
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
How to Survive an Emotionally Toxic Workplace
Ensuring Safe and Effective Pharmaceutical Products: A Comp…
Best Practices in Complaint Management for Regulatory Compl…
Human Factors Usability Studies Following ISO 62366 and FDA…
Embracing Diversity and Inclusion in Talent Acquisition
Form W-9 Compliance to Avoid Penalties: TIN Verification, B…
Gossip-Free: Leadership Techniques to Quell Office Chatter
Updated Metro 2®, e-OSCAR and the New Tougher FCRA/CFPB Com…
Tattoos, hijabs, piercings, and pink hair: The challenges …
Divorce, Adoption and Other Special Tax Topics
Understanding and Analyzing Financial Statements
With Mandatory Paid Leave Gaining Ground Is It Time To Do A…
Design History File (DHF), the Device Master Record (DMR) a…
Setting up Quality System for FDA Regulated Products: Tips …
Is Your Culture Working For or Against Your Success? If You…
Marketing to Medicare or Medicaid Beneficiaries - What You …
The Five Cs Of Commercial Credit: The Basic Elements Of Cre…
Sunshine Act Reporting - Clarification for Clinical Research
Documenting Misconduct that Will Stand Up in Court
Managing Toxic & Other Employees Who have Attitude Issues
FDA Regulation of Artificial Intelligence/ Machine Learning
Stress, Change And Team Resilience Through Humor: An Intera…
Excel - Lists and Tables - A Beginner's Guide to Managing L…
Pharma 4.0: Next Generation Technology Approach to GxP Prod…
Managing Complex Projects - Project Management
Patient Gifts, Discounts and Freebies: What You Can and Can…
All About Civility - Eliminating a Culture of Gossip Rumors…