Supplier Controls to Meet Tougher U.S. FDA Requirements
Tuesday, May 22, 2012 from 10:00 AM to 11:30 AM (PDT)
Palo Alto, CA
This 90-minute webinar on supplier controls 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.
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.
- 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"
Who Will Benefit:
The following personnel from Medical Device, Diagnostic, Pharmaceutical, Neutraceutical and Biologics fields will benefit:
- Senior management
- Regulatory Affairs
- Quality Assurance
- 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.
For Registration :
When & Where
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.