2-Hour Virtual Seminar on Supplier and Service Provider Controls: FDA Expectations
This webinar will help you gain a better understanding of the requirements regarding 21 CFR Section 820.50, Also this webinar will compare GHTF Guidance (GHTF/SG3/N17:2008) on Control of Products and Services Obtained from Suppliers VS 21 CFR Section 820.50 Requirements.
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This webinar will provide the regulatory requirements (US) of 21 CFR Section 820.50 (Purchasing Control) for the Medical Device industry and provide you with examples. It will furnish details on what should your Purchasing/Supplier Control management system address.
Supply chain activities (including, the increase in outsourcing materials, components , manufacturing and services) have become more complex to manufacturers and oversight has become more challenging and complicated. Manufacturers are required to manage carefully their entire supply chain. Purchasing and Supplier Control deficiencies have ranked in the top 10 deficiencies related to warning letters. The FDA focuses on how companies are addressing in procedures and their actual execution on : selection, evaluation, acceptance criteria establishment, communication process (including change notifications), controlling, and monitoring their suppliers and service providers among other related activities. As a result of recalls, there has been public concern regarding insufficient oversight of the entire supply chain from regulated companies.
Why should you Attend:
This webinar will compare GHTF Guidance (GHTF/SG3/N17:2008) on Control of Products and Services Obtained from Suppliers VS 21 CFR Section 820.50 Requirements. At the end of this webinar, there will be challenges and conclusion sections.
Areas Covered in the Session:
- FDA Regulatory Background
- Intent of 21 CFR Section 820.50 (Purchasing Controls)
- Who is Responsible
- Key Definitions
- Supplier and Service Providers Relationship with the Manufacturer
- Who are the Suppliers and Service Providers
- Overall Process of Supplier Quality Activity
- What Does 21 CFR Part 820 Require
- Document Control Requirements
- FDA Tracking Expectation
- Evaluation and Selection/ Supplier Management and Qualification/ Questionnaire/ Supplier Audits
- Guide to Inspections of Medical Device Manufacturers: Purchasing Controls - 21 CFR820.50
- Communication and Change Notification
- Level of Controls
- Risk Management/ Assessment
- Quality Agreements
- Link between 21 CFR Part 820.50 (Purchasing Controls) and GHTF/SG3/N17:2008
- GHTF/SG3/N17:2008 Six Phases
- GHTF/SG3/N17:2008 Vs 21 CFR Section 820.50
- GHTF/SG4/N84-Part 5: Audits of Manufacturer Controls of Suppliers
- Supplier Metrics Data Sources and Examples of What Should Be in Your Metrics
- Warning Letters and Deficiencies Related to Supplier Controls
Who Will Benefit:
- Detailed information to help you gain a better understanding of the requirements regarding 21 CFR Section 820.50
- How does 21 CFR Section 820.50 relate to other Quality System elements , the link it has with GHTF/SG3/N17:2008 and comparison between both
- It will provide you with details regarding Evaluation and Selection of Suppliers/ Supplier Management and Qualification/ Questionnaire Content/ Quality Agreement content/Supplier Audits/ Risk Management-Assessment tools and more
- Supplier metrics you can implement
- Understand some of the challenges
- Regulatory Compliance Professionals
- Quality Assurance Professionals
- Quality Control Professionals
- Supply Chain Personnel
- Regulatory Affairs Professionals
- Regulatory Compliance Professionals
- Complaint Handling Professionals
- Supplier Quality Engineers
- Purchasing Personnel
- Manufacturing and Design Engineers
- Process Development Personnel
Vanessa Lopez - Sr. Principle Quality, Regulatory and Compliance Consultant. She has held a wide variety of leadership roles in the Medical Device (Class: I, II, and III), Pharmaceutical (API; Finished Product) and Environmental regulated industries as well as the Consulting Services industry.
She has worked for Edwards LifeSciences, Roche Diagnostics, Eli Lilly and Company, Pall LifeSciences, among others. She possesses over 25 years of experience focused on development, implementation, driving improvements and monitoring of Quality Assurance, Quality Control, Regulatory Compliance, Regulatory Affairs, Quality Systems and Supplier Quality activities.
Ms. Lopez has in-depth knowledge, coaches on interpretation and application of US regulations, EU directives/EU MDR and IVDR, specific country regulations (Japan, Canada, and others), national/international standards and guidance documents. She has also held positions within the CAPA, Material, Safety and Management Review Boards as well as represented Quality in Design Control phases.