Notified bodies and the FDA cannot require your suppliers to meet the quality system regulations, so they must make sure you are exercising sufficient control over those suppliers. You must make sure your supplier management and system meet all required regulations, especially for critical suppliers.
This class will review the QSR and ISO requirements for supplier evaluation, including defining the types of suppliers that require evaluation, including “critical” suppliers and outsourced processes. The QSR and ISO requirements for supplier assessment will be defined as well. The webinar will discuss the application of a risk-based process resulting in a customized supplier management system.
WHY SHOULD YOU ATTEND?
Sure, you depend on your suppliers to provide you with goods and services, but can your system prove that you have sufficient control over your suppliers to assure auditors and regulatory agencies that your product is safe and meets all your requirements? Your supplier management program can comply, but is it cost-effective? If not, your unquantifiable overhead costs may be out of control. Is your supplier management program collaborative with your suppliers? If your company is too demanding of your suppliers, you risk alienating them or even worse losing them – try explaining that to your supply chain management!
AREA COVERED
Supplier Selection
- Review of FDA and ISO requirements
- Types of suppliers that must be qualified
- Defining critical suppliers
- Classification of suppliers
- Outsourced processes
- The Quality Agreement
- Recommended Practices
Supplier Assessment
- Review of FDA and ISO requirements
- Recommended Practices
- How to avoid “Death by Supplier Audit”
- Documentation requirements
LEARNING OBJECTIVES
- Understanding of QSR requirements for supplier evaluation, and their application
- Understanding of ISO requirements for supplier evaluation, and their application
- Definition of types of suppliers, and those that require evaluation
- Best practices for “critical” suppliers and outsourced processes
- Understanding of QSR requirements for supplier assessment, and their application
- Understanding of ISO requirements for supplier assessment, and their application
- Application of risk-based process resulting in a customized supplier management system
WHO WILL BENEFIT?
This webinar will provide valuable assistance to all regulated companies that are interested in implementing and maintaining a supplier management program that is both compliant and cost-efficient. The employees who will benefit include:
- Supply chain management
- Buyers
- Purchasing management
- CAPA Coordinators
- Regulatory management
- QA management
- Executive management
- Internal auditors
Sure, you depend on your suppliers to provide you with goods and services, but can your system prove that you have sufficient control over your suppliers to assure auditors and regulatory agencies that your product is safe and meets all your requirements? Your supplier management program can comply, but is it cost-effective? If not, your unquantifiable overhead costs may be out of control. Is your supplier management program collaborative with your suppliers? If your company is too demanding of your suppliers, you risk alienating them or even worse losing them – try explaining that to your supply chain management!
Supplier Selection
- Review of FDA and ISO requirements
- Types of suppliers that must be qualified
- Defining critical suppliers
- Classification of suppliers
- Outsourced processes
- The Quality Agreement
- Recommended Practices
Supplier Assessment
- Review of FDA and ISO requirements
- Recommended Practices
- How to avoid “Death by Supplier Audit”
- Documentation requirements
- Understanding of QSR requirements for supplier evaluation, and their application
- Understanding of ISO requirements for supplier evaluation, and their application
- Definition of types of suppliers, and those that require evaluation
- Best practices for “critical” suppliers and outsourced processes
- Understanding of QSR requirements for supplier assessment, and their application
- Understanding of ISO requirements for supplier assessment, and their application
- Application of risk-based process resulting in a customized supplier management system
This webinar will provide valuable assistance to all regulated companies that are interested in implementing and maintaining a supplier management program that is both compliant and cost-efficient. The employees who will benefit include:
- Supply chain management
- Buyers
- Purchasing management
- CAPA Coordinators
- Regulatory management
- QA management
- Executive management
- Internal auditors
Speaker Profile
Jeff Kasoff, RAC, CMQ/OE, LBB, is the Principal at Lean to Quality, LLC. He has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from startup to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes. Jeff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies. Jeff has the following …
Upcoming Webinars
Understanding and Analyzing Financial Statements
Onboarding is Not Orientation: How to Improve Your New Hire…
Managing Toxic & Other Employees Who have Attitude Issues
Do's and Don'ts of Documenting Employee Behaviour, Performa…
Gossip-Free: Leadership Techniques to Quell Office Chatter
Outlook - Master your Mailbox - Inbox Hero Inbox Zero
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
Excel & ChatGPT Synergy Masterclass: Unleashing Financial A…
Introduction to Microsoft Power BI Dashboards
Drive Recruiting Success with the Using Recruiting Metrics …
2025 EEOC & Employers: Investigating Claims of Harassment …
Impact Assessments For Supplier Change Notices
Mastering Job Descriptions: Legal and Practical Insights fo…
Effective Onboarding: How to Welcome, Engage, and Retain Ne…
What is in Store for Employers When Updating Employee Handb…
Designing Employee Experiences to Build a Culture of Compli…
Onboarding Best Practices for 2025: Proven Strategies to Po…
Accounting For Non Accountants : Debit, Credits And Financi…
Creating a Successful Job Rotation Program
The Anti-Kickback Statute: Enforcement and Recent Updates
FDA Compliance And Laboratory Computer System Validation
How To Create Psychological Safety in your Organization
Aligning Your HR Strategy with Your Business Strategy
Transforming Anger And Conflict Into Collaborative Problem …
How to Give Corrective Feedback: The CARE Model - Eliminati…
I-9 Audits: Strengthening Your Immigration Compliance Strat…
Zero Acceptance Sampling to Reduce Inspection Costs
Identifying, Managing, and Retaining High Potential Employe…
AI at Your Service: Enhancing Your Microsoft OfficeSkills w…
Why EBITDA Doesn't Spell Cash Flow and What Does
FDA Recommendations for Artificial Intelligence/Machine Lea…
Project Management for Non-Project Managers - How to commun…
Dealing With Difficult People In Life & Work
Developing and Implementing Quality Culture in the Organiza…
2-Hour Virtual Seminar on the 6 Most Common Problems in FDA…
Enhancing Pivot Tables with Images: Visualize Your Data Lik…
How to Write Effective Audit Observations: The Principles f…
How to Write Contracts for Procurement Professionals
Uplifting the Credibility of HR: How to Build the Credibili…
Strategic Interviewing & Selection: Getting the Right Talen…
Performance of Root Cause Analysis, CAPA, and Effectiveness…
FDA Audit Best Practices - Do's and Don'ts
Unlock Employee Loyalty: Stay Interviews Will Keep Them Eng…
How to Manage the Legal Landmine of the FMLA, ADA and Worke…
Excel Lookup Functions: VLOOKUP, HLOOKUP, and XLOOKUP Made …