Master Verification and Validation Planning to Meet Tougher U.S. FDA Requirements

Why Should You Attend:

The last few years have seen the U.S. FDA come under increasing negative public scrutiny. High profile drug recalls, food chain problems and contamination, import problems, resignations. Now a new commissioner vows no more “business as usual”. Company and submission data must be more science-based. Warning Letters and additional compliance actions are being driven by the need to ‘encourage’ more voluntary compliance by industry. Recalls point to serious V&V shortfalls that should have been avoided.

How can companies allocate scarce resources to those verification and validation activities that have the greatest impact to product quality / safety, minimize resources on minor issues, and still satisfy the regulatory agencies? How can companies learn from the experiences of others, and break out of the “business as usual” mold to proactively address and eliminate any such “triggers”, reduce “fire fighting” and minimize / eliminate major systemic validation problems.

This webinar will discuss and evaluate the climate that has resulted in this call for change, and flag any mind set or practice that is an impediment to heightened compliance in V&V planning. How to address and resolve underlying compliance issues or product problems. How companies can meet the new regulatory climate and be competitive, companies need to reevaluate their V&V systems, related documentation, and root out the old mind set, and replace it with forward thinking, compliant and proactive new V&V systems and procedures.

Areas Covered in the seminar:

• Shifting FDA V&V expectations.
• Key Areas in Product V&V.
• Key Equipment, Process, Software, and QMS (Pt 11) V&V Activities.
• Expected regulatory “Hot Buttons”.
• Avoid complacency from past “good” audits.
• Problem areas.
• Where to direct scarce resources now.

Who will benefit:

This webinar will provide valuable assistance to personnel in all regulated companies responsible for cGMP compliance. This information applies to personnel / companies in the Medical Device, Pharmaceutical, Diagnostic, Biologics and Dietary Supplements fields. The employees who will benefit include:

• Senior management, project leaders, internal / external consultants.
• Mid-level management and supervisory personnel.
• Corporate and site coordinators.
• Regulatory affairs.
• Quality systems personnel/QAE.
• R&D and engineering staff.
• Production personnel.
• New product development, equipment and QMS validation personnel, those involved in regulatory submissions.

Instructor Profile:

John E. Lincoln, is Principal of J. E. Lincoln and Associates, a consulting company with over 28 years experience in U.S. FDA-regulated industries. John has worked with companies from start-up o 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.

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