2-in-1 Virtual Seminar: FDA's Strategic Priorities and Supplier Control Requirements

Agenda (all time in PDT):

• 8 am to 9:30 am - Session I
• 9:30 am to 9:45 am - Break
• 9:45 am to 11:15 am - Session II
• 11:15 am to 11:30 am - Q&A

Session One: U.S. FDA’s Strategic Priorities - Future Directions

This session will evaluate important areas for regulated companies to focus in 2013-2014, based on the U.S. FDA’s recent pronouncements. We will examine the FDA's recently instituted annual "Strategic Priorities" initiative, with emphasis on the second half of 2013 and 2014. Such a review will focus on the broad range of issues a company's senior management and QA/RA need to consider in their annual Management Review of their existing quality management system. This review takes on added urgency as a result of the stated intent of the Agency to get tougher across the board in its expectations for the medical products industry and what the FDA and industry need to do internally.

An additional review of recent information from the Agency, other goals of the Agency that have already been translated into action in the past year will provide direction in areas of concern and what to expect in the future. This will be performed by a review of applicable FDA "Strategic Priorities" areas for required review or related industry problem areas. Major 510(k) changes already proposed and/or implemented will be discussed. This information should be a basis for management reviews and remediation activities. Anticipation and addressing of weak spots proactively will further prove a company is "in control", assist in timely review of submissions to the Agency, and in any existing remediation efforts.

Training Objectives:

• Mandated Areas for Annual Reviews
• The FDA's "Strategic Priorities" for 2013 and Beyond
• Tougher Regulatory Science -- What "Better Science" Really Means
• Device, Pharmaceutical and Biological Issues
• General CGMP Issues -- Strengthened Compliance
• Major Pending 510(k) Changes
• FDA's Life Cycle View Requirements
• Safety / Integrity of Global Supply Chain
• Heightened Supplier Issues
• FDA Clearance / Approval Only the Beginning -- Product "Lifecycles"

Session Two: Supplier Controls to Meet Tougher Requirements

The U.S. FDA continues to increase its requirements for tighter control of vendors / suppliers / outsourcing. CE-Marking requirements by EU / Notified Bodies are also tightening.

There has been a major shift in the emphasis of U.S. FDA requirements for supplier CGMP compliance. The same is true with European regulatory expectations. The FDA has implemented major global initiatives. Companies are required to tightly manage their entire supply chain. The infrastructure behind the COA / COC is being challenged. Such changes in focus has a major impact on individual compliance objectives, efforts and measurements of success.

The Agency has come under increasing negative publicity due to major publicized product failures / recalls, leading to public concern over insufficient oversight of the entire medical product supply chain, including global outsourcing -- Of both raw materials, components, as well as services. "Better science" requirement impacts suppliers as well. All this is affecting the Agency's approach to audits and their expectations for companies. These areas of change will be evaluated to see how to better prepare address supplier chain management and vendor audits.

Training Objectives:

• Avoid complacency from past "good" FDA / ISO audits
• Supplier Ranking Models
• Mandated Supplier Controls; Change Controls
• COAs / COCs
• The Tiered Risk-Based Audit Approach
• Getting Vendors “On Board”
• "Entropy"; Maintain "the Edge" / "State of Control"

Who will Benefit:

These webinar-based training sessions will provide valuable assistance to all regulated companies that need to review and modify their Master Validation Planning and Plan(s). While this information is focused on Medical Devices, its principles apply to personnel / companies in the Pharmaceutical, Diagnostic, and Biologics fields. The employees who will benefit include:

• Senior and middle management and staff
• Regulatory Affairs
• QA/QC
• Purchasing
• R&D
• Production Management
• Manufacturing Engineers
• Process Engineers
• Product Engineers
• Software Engineers
• Project Managers
• Medical Products Vendors
• Sales and Marketing

Instructor Profile:

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company, with over 31 years experience in U.S. FDA-regulated industries, 17 of which as a full time independent FDA-regulated industry consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. John is a graduate of UCLA.

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