Documenting a Risk-Based Quality System - for Compliance and Cost-Savings

This webinar will help attendees evaluate their existing Quality Management System (QMS) in light of the changes in the FDA's CGMP/QMS enforcement paradigm. Attendees will learn how to document a risk-based QMS at their organization for both compliance and cost savings.

Why Should You Attend:

There is an on-going major shift in the emphasis of U.S. FDA CGMP and other world-wide regulatory compliance requirements, requiring a re-evaluation of a company's Quality Management System (QMS). These changes in focus have a major impact on individual compliance objectives, efforts and measurements of success. Major high profile drug and device problems/recalls, class action lawsuits, on-going negative publicity resulting in growing public concerns. This affects even once highly respected companies. All of which has increased the Agency's expectations for CGMP compliance and a company's QMS by industry. The FDA also uses CGMP compliance actions/audits to drive industry to proactive compliance. And they're 'piercing the corporate veil' to prosecute senior management involved in lying or fraud.

This webinar will evaluate the chief areas of FDA CGMP/QMS compliance concerns and recent audit emphasis to better understand and react to this new regulatory climate. The resulting 'proof' is in risk-based, resource driven/cost-effective QMS documentation.

Areas Covered in the Webinar:

The 'targets'

• Avoid complacency from past 'good' U.S. FDA/EU ISO audits
• The basic underlying issues
• Why 'documentation'
• Proactive company system responses - where to shift focus first
• Where to direct scarce resources
• A risk-based phased approach
• Avoid 'entropy' - Prove 'in control'
• Maintain 'the edge'

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies in evaluating their existing compliance and existing QMS emphasis in light of the changes in the FDA's CGMP/QMS enforcement 'paradigm'. This webinar will benefit personnel/companies in the pharmaceutical, medical device, combo products, diagnostic, neutraceutical and biologics fields. The employees who will benefit include:

• Senior Management
• Regulatory Affairs Personnel
• Quality Assurance/Quality Control Staff
• Production Personnel
• Engineering Personnel
• All personnel involved in a U.S. FDA-regulated environment. Especially those involved in regulatory compliance, QMS/CGMP training and auditing, and the production and documentation of regulated medical products.