Changing Supplier Controls Requirements
May 7, 2013
Location
Online Event
2600 E. Bayshore Road
Palo Alto, California 94303
USA
Description
This training on FDA supplier controls will help you refine your supplier chain management and vendor 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.
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 of 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 Seminar:
- 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"
Organized by
ComplianceOnline
2600 E. Bayshore Road
Palo Alto, California 94303
United States of America
More Information
Contact: Referral
Email: referral@complianceonline.com
Phone: +1-650-620-3915
Event's Website
