Supplier Evaluation and Internal Auditing for FDA and ISO 13485 Compliance: Pack of Three Courses

This pack of three training courses provides 3.5 hours of training on review of QSR and ISO requirements for supplier evaluation and assessment, and cost efficient options to many of the common practices and also provide the principles and practices needed to effectively develop, implement, and perform internal quality management system audits that comply with the requirements of the FDA QSR Regulation and ISO 13485 and EU MDR 745/2017.

All Modules:

Module 1: Supplier Management: Challenges and Opportunities
Module 2: Supplier Management with the new Medical Device Regulation EU MDR 745/2017
Module 3: Streamlining your QMS and Audit System for Remote Audits

Part 1 : Supplier Management: Challenges and Opportunities

Areas Covered in the Webinar:

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

Instructor Profile: Jeff Kasoff, RAC, CMQ/OE, LBB, 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 certifications: Manager of Quality and Organizational Excellence certification from ASQ, Regulatory Affairs Certification from RAPS, and Lean Black Belt from IIE.

Part 2 : Supplier Management with the new Medical Device Regulation EU MDR 745/2017

Areas Covered in the Webinar:

• Closer regulatory binding of the ISO to the new EU MDR
• Responsibilities for outsourced processes
• What are outsourced processes?
• Adjustments in the management review
• Adjustments in the audit process
• How to onboard the supplier?
• Examples from outsourced R&D-, manufacturing-, lab-test - processes
• Examples from outsourced sales processes

Instructor Profile: Prof. Dr. Dr. h.c. Frank Stein, medical engineer, medical engineering experience for 27 years, clinical and research experience in cardiac surgery and cardiology, industrial experience in ophthalmology, neurology, traumatology and dental implants, active implants, active devices, medical software, international project and regulatory consulting experience in Europe, North-America, Asia, Australia, Brazil.

Part 3 : Streamlining your QMS and Audit System for Remote Audits

Areas Covered in the Webinar:

• Develop or streamline an internal auditing system that is compliant to FDA cGMP/ Quality System Regulation and ISO 13485
• Manage an internal audit system
• Difference between internal and external audits
• How the internal auditing system can add value to your quality system and your company
• What makes a good internal audit
• Skill required for an internal auditor
• What the FDA must see to verify that you are conducting your internal audits as required

Instructor Profile: Betty Lane, has over 30 years’ experience in medical device quality assurance and regulatory affairs. She is the founder and President of Be Quality Associates, LLC, a consulting company helping small and medium sized medical device and diagnostic companies implement and improve their quality systems for both FDA and ISO 13485 compliance band business when they became FDA and industry requirements. Her are areas of expertise include training, auditing, supplier management, design controls, software validation and general safety.

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