Documenting a Risk-Based Quality System - for 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.

Instructor Profile:

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 32 years’ experience in U.S. FDA-regulated industries, 18 as a full-time consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. John is a graduate of UCLA.

Topic Background:

The U.S. FDA's expectations for a company's QMS is getting tougher as are EU Notified-Body requirements. Facts from field audits bear that up. Past methodologies are no longer acceptable. The Agency continues to use high-profile cases to drive compliance to smaller companies. Global outsourcing and suppliers are under FDA audits, with new field offices / posts opened worldwide. On-going negative publicity in the device and pharma industries, and major changes within the Agency are driving change. Once model companies have fallen flat or worse. Don't let you or your company be caught off guard by these major shifts in emphasis. Enhance awareness and modify CGMPs adherence to match this FDA shift -- and benefit your company. Improve and document a risk-based QMS at your company -- for both compliance and cost savings.

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