Compliant Supply Chain & Manufacturing for Medical Devices - Comprehensive Training Package (8 Courses)

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.

This package of eight webinar recording CDs covers those issues that can throw up compliance issues in the manufacturing process as well as the supply chain. Topics covered include: decommissioning and transferring the medical OEM molding operation; the US FDA’s new global engagement initiative; supplier controls; investigating environmental monitoring excursion limits; project management to meet CGMP requirements; dealing with sterility failures and bioburden excursions; risk-based supplier controls to meet FDA and ISO 13485 requirements; and supplier evaluation and assessment.

How It Works:

Each webinar CD has a series of modules. Our speakers have delivered the modules using PowerPoint slides.

This training is convenient to attend individually or in groups. You don’t have to travel from your office. This means you can afford to have your whole team attend. As the webinar recording CDs are licensed to be used multiple times in a location, you can schedule the training as many times for as many groups/batches as you wish. Your team members will learn the material together; everybody will get the same information.

Webinar Topics:

Module 1: How to Decommission a Medical OEM Molding Operation and Transfer it to a “World Class” Medical Contract Manufacture
Module 2: The U.S. FDA's New Global Engagement Initiative
Module 3: Supplier Controls to Meet Tougher U.S. FDA Requirements
Module 4: How to Investigate Environmental Monitoring Excursion Limits
Module 5: Project Management To Meet CGMP Requirements
Module 6: You have a sterility failure or bioburden excursion - Now what
Module 7: Risk-based Supplier Control: How to Meet FDA and your ISO 13485 Notified Body’s Expectations and Reduce your Own Risk
Module 8: Supplier Evaluation and Assessment - FDA QSR and ISO 13485 Requirements

Who will Benefit?

These webinar recording CDs will be beneficial to all professionals working in the medical device industry, but specially:

• Quality Managers
• Regulatory Affairs Managers
• Risk Managers
• Design Control Managers
• Validation specialists
• Business Development teams
• Corporate auditors
• Private equity firms
• Consultants
• Plant managers and operation personnel in the medical industry (OEM's and suppliers)
• Project management teams
• Strategic supply chain teams
• Manufacturing engineers
• R&D, product development engineers and managers associated with validations

Webinars Iincluded in the Package:

Module 1 : How to Decommission a Medical OEM Molding Operation and Transfer it to a “World Class” Medical Contract Manufacturer (Duration: 60 minutes)

This compliance training webinar will provide processes and procedures to all medical device companies that are thinking of transferring equipment, molds, dies, systems and processes to contract manufacturers. It will follow a recent successful case study in the medical industry.

Areas Covered in the Webinar:

• Should a medical company decommission and/or transfer an operation to a world class contract manufacturer
• Gap analysis
• Choose a world class manufacturer
• Cost of validation
• Risk plan
• Contract negotiation
• Master validation plan
• Mold and component transfer
• Pitfalls
• Successful transfer

About the Instructor:

Robert Braido, has 35 years of experience in the medical industry. He is presently the principle at Visionary Consulting LLC and has been consulting with medical OEM's and suppliers to the medical industry for over 5 years.

Module 2 : The U.S. FDA's New Global Engagement Initiative (90 Minutes)

This webinar will discuss the new FDA "Global Engagement" Initiative for new areas for heightened CGMP compliance from U. S. FDA-regulated companies and their global partners. It will cover areas for increased awareness, focus, and remediation, and the approaches that are now mandated.

Areas Covered in the Webinar:

• The U.S. FDA's New Global Engagement Initiatives
• Recent global industry trends, bad and good
• Major foreseeable problem areas
• How the FDA initiatives impact regulated industries
• Immediate actions to take
• Long-term correction / preventive action of FDA-defined problem areas

About the Instructor:

John E. Lincoln, is Principal of J. E. Lincoln and Associates, a consulting company with over 30 years experience in U.S. FDA-regulated industries, 16 of which as head of his own consulting company. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan.

Module 3 : Supplier Controls to Meet Tougher U.S. FDA Requirements (90 minutes)

This webinar will help you refine your supplier management and audits to match the FDA's tougher position. We will evaluate the chief areas of change to see how to better prepare a supplier chain management and audit program.

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
• Essential Supplier Controls
• Where to direct scarce resources
• The Tiered Risk-Based Audit Approach
• Maintain "the edge"; proactively address "entropy"

About the Instructor:

John E. Lincoln, is Principal of J. E. Lincoln and Associates, a consulting company with over 30 years experience in U.S. FDA-regulated industries, 16 of which as head of his own consulting company. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan.

Module 4 : How to Investigate Environmental Monitoring Excursion Limits (60 minutes)

This webinar will review the best practices for setting environmental monitoring alert and action levels for viable and non-viable data including product bioburden. In addition this webinar will address the responses/actions that should be taken when an excursion in the alert or action level occurs.

Areas Covered in the Webinar:

• Best practices for monitoring and establishing limits
• Product bioburden
• Viable particulate
• Non-viable particulate
• Do I really need to investigate if the alert limits are exceeded?
• Investigating an alert limit excursion
• In the environment
• On the product
• Who to investigate
• What to investigate
• When - what is the appropriate timeline to investigate
• Where should you look
• Documenting the investigation story

About the Instructor:

Gerry O'Dell, is owner and President of Gerry O'Dell Consulting, a consulting firm based in the United States with medical device and pharmaceutical clients around the world.  Prior to starting Gerry O'Dell Consulting, she worked for Johnson & Johnson Medical, Inc. as the Manager of Laboratory & Sterilization Services which managed the sterilization program for J&J Medical in addition to providing laboratory testing services to several J&J companies.

Module 5 : Project Management To Meet CGMP Requirements (90 minutes)

This webinar will show how you can meet key FDA and EU MDD regulatory requirements for the project you manage. It will focus on proven tools and techniques for successful development and implementation of project management planning.

Areas Covered in the Webinar:

• Meet key requirements of the CGMPs/ISO with formal project mgmt
• Why formal Project Management
• The Three Most Common Tools - Gantt, CPM, PERT
• How to Compile - Simple Spreadsheet Techniques
• Work breakdown Structure, Milestones, Tasks
• Effectiveness -- Determining and Monitoring
• A Suggested Template
• One Major, But Often Neglected, Use

About the Instructor:

John E. Lincoln, is Principal of J. E. Lincoln and Associates, a consulting company with over 30 years experience in U.S. FDA-regulated industries, 16 of which as head of his own consulting company. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan.

Module 6 : You have a Sterility Failure or Bioburden Excursion - Now What? (60 minutes)

This webinar will discuss the various items that should be investigated to determine the root cause, when a failure occurs during a sterility test, and the follow up to the investigation.

Areas Covered in the Webinar:

• Is this result really a failure that needs to be investigated?
• What items are important to investigate during sterilization process validation?
• If a failure occurs during sterilization process validation what actions can you take?
• The lab says the routine process BI is positive, what now?
• My dose audit did not pass, what does that mean?
• The periodic bioburden testing exceeded the established alert limit, what actions should be taken?
• What do you do if the bioburden action limit is exceeded?
• How to determine if the bioburden excursion has an impact to sterilization.

About the Instructor:

Gerry O'Dell, is owner and President of Gerry O'Dell Consulting, a consulting firm based in the United States with medical device and pharmaceutical clients around the world.  Prior to starting Gerry O'Dell Consulting, she worked for Johnson & Johnson Medical, Inc. as the Manager of Laboratory & Sterilization Services which managed the sterilization program for J&J Medical in addition to providing laboratory testing services to several J&J companies.

Module 7 : Risk-based Supplier Control: How to Meet FDA and your ISO 13485 Notified Body’s Expectations and Reduce your Own Risk (90 minutes)

This webinar training will provide the information needed to assure that the supplier management program is in compliance with the latest European and international guidelines requiring a risk-based supplier management program. It will look at how to improve the supplier management system to meet both the FDA and ISO expectation while potentially reducing cost of compliance.

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.

About the Instructor:

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.

Module 8 : Supplier Management for FDA Compliance (60 minutes)

This webinar will review in detail the FDA QSR and ISO requirements for supplier evaluation and assessment, and discuss cost effective options for many of the common practices for achieving compliance.

Areas Covered in the Webinar:

• QSR and ISO 13485 requirements for supplier selection and assessment.
• How to qualify new suppliers in a cost efficient manner.
• How to assess current suppliers in a cost efficient manner.
• How to perform supplier-related corrective action.
• Minimum documentation requirements for supplier qualification, assessment, and related corrective action

About the Instructor:

Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of consumables and instrumentation in the endoscopy field. In this position, Jeff is responsible for oversight of the quality system, including phase approval of design history files. For the past 13 years, Jeff served as Director of Regulatory Affairs at Life-Tech, Inc., where he was responsible for corporate compliance.

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