Changing Supplier Controls Requirements

Why Should You Attend:

Recent FDA statements and actions indicate the past ways of managing a company's supply chain / outsourcing will no longer be acceptable. Increasingly reports from the field indicate that the agency is using high-profile cases to drive compliance to smaller companies and suppliers. CGMP compliance cannot be passed on to suppliers; however suppliers must meet specific CGMP requirements. Proof for better science is also a new expectation. "Business as usual" is never acceptable. Don't be caught off guard by these major shifts in emphasis.

This presentation will help you refine 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. This webinar will provide valuable assistance to all regulated companies in evaluating their existing supply chain control / compliance and vendor audits in light of the changes in the FDA's CGMP supplier management paradigm. Once potential problem areas are identified, a company can evaluate / perform a gap analysis, and then put in place the necessary fixes to ensure continuing compliance.

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

Who Will Benefit:

The following personnel from the medical device, diagnostic, pharmaceutical, neutraceutical and biologics fields will benefit:

• Senior management
• Regulatory affairs
• Quality assurance
• Purchasing
• Production
• Engineering
• All personnel involved in a U.S. FDA-regulated environment, especially those involved in the establishment, monitoring, and review / audits of outsourced parts and services used in regulated medical products

John E Lincoln
Principal, J E Lincoln and Associates

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. John has also managed pilot production, regulatory affairs, product development / design control projects; with over 24 years of experience, primarily in the medical device industry – working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco / Mallinckrodt. John serves on the Reader and Editorial Review Boards of MDDI Magazine and the Journal of cGMP.

Topic Background:

There has been a major shift in the emphasis of U.S. FDA requirements for supplier CGMP compliance. 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.

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