Compliant Supply Chain & Manufacturing for Medical Devices - Comprehensive Training Package (5 Courses)

This comprehensive training package is aimed at helping medical device companies ensure that their supply chain controls and manufacturing processes comply with existing regulations.

This comprehensive training package is aimed at helping medical device companies ensure that their As manufacturing becomes increasingly global, with responsibility for various parts of the final product vesting with multiple parties, regulatory compliance can be challenging for medical device firms. Compliance, therefore, has to be achieved not just in the actual manufacturing process, but throughout the supply chain.

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All Modules:

Module 1: Supplier Quality Agreements - Essential for Suppliers of Many Outsourced Processes
Module 2: Changing Supplier Controls Requirements
Module 3: Best Practices for Lean Supplier Management in Compliance with FDA and ISO 13485 Requirements
Module 4: Supplier and Service Provider Controls: FDA Expectations
Module 5: Creating a Risk-based Supplier Management program

Module 1 : Supplier Quality Agreements - Essential for Suppliers of Many Outsourced Processes - (Last Recorded Date: Aug-2017)

Areas Covered in the Webinar:

• Types of suppliers that should have QA agreements to ensure FDA and ISO 13485 compliance
• Explanation and use of the Global Harmonization Task Forces (GHTF) and NBOG supplier guidance documents to create QA agreements
• How to create supplier QA agreements and the best way to implement them
• Definition of and requirements for critical suppliers
• Supplier agreements best practices

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.

Module 2 : Changing Supplier Controls Requirements - (Last Recorded Date: June-2017)

Areas Covered in the Webinar:

• The Globalization of the Supply Chain and What That Means
• Avoid Complacency from Past Good FDA / ISO audits
• Supplier Ranking Models
• Mandated Supplier Controls; Change Controls
• COAs / COCs
• The Tiered Risk-Based Audit Approach
• Entropy; Maintain the Edge/State of Control

Instructor Profile:

John E. Lincoln, consultant, has successfully designed, written over 50 ISO 14971-compliant Risk Management Files / Reports, including FMECA and FTA analysis, many in response to FDA 483 observation, which have subsequently passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide.

Module 3 : Best Practices for Lean Supplier Management in Compliance with FDA and ISO 13485 Requirements - (Last Recorded Date: Jul-2012)

Areas Covered in the Webinar:

• Supplier Selection
• Review of FDA and ISO requirements
• Types of suppliers that must be qualified
• Defining critical suppliers
• Outsourced processes
• Recommended Practices
• Supplier Assessment
• Review of FDA and ISO requirements
• Recommended Practices
• Justification of Desktop Audits
• Documentation requirements

Instructor Profile:

Jeff Kasoff, RAC, is the director of quality at Medivators, a leading manufacturer of endoscopy consumables and instrumentation. In this position, Mr. Kasoff is responsible for oversight of the quality system, including the CAPA program, and is the liaison with FDA.

Module 4 : Supplier and Service Provider Controls: FDA Expectations - (Last Recorded Date: Oct-2016)

Areas Covered in the Webinar:

• 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 CFR 820.50
• 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
• Challenges

Instructor Profile:

Vanessa Lopez is senior principle quality, and a 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 Pall LifeSciences among others.

Module 5 : Creating a Risk-based Supplier Management program - (Last Recorded Date: Feb-2017)

Areas Covered in the Webinar:

• The types of suppliers that must be qualified according to the FDA and ISO 13485
• Explanation, and use of the Global harmonization Task Force s(GHTF) and NBOC supplier guidance documents that you could be audited to
• How to create or bring your supplier program into compliance with the these guidance documents
• Definition of and requirements for Critical suppliers
• Defining and controlling supplier risk and why this benefits you
• Supplier qualification and control, best practices

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.