2-in-1 Virtual Seminar: FDA's Strategic Priorities and Supplier Control Requirements
Tuesday, August 13, 2013 from 8:00 AM to 11:30 AM (PDT)
This virtual seminar will start by evaluating important areas for regulated companies to focus in 2013-2014, based on the U.S. FDA’s recent "Strategic Priorities" initiative. The second-half of the session will discuss how FDA's global initiatives affect supplier chain management and vendor audits and how you can prepare to address them.
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
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.
- 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"
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.
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.