U.S. FDA’s Strategic Priorities – 2014 and Beyond

$299.00

Description:

This webinar will examine the FDA’s recently instituted annual “Strategic Priorities” initiative, with emphasis on 2014, and future issues. Such a review will focus on the broad range of issues a company’s senior management and QA/RA need to consider in their annual Management Review of their existing quality management system.

An additional review of recent information from the Agency, other goals of the Agency that have already been translated into action in the past year will provide direction in areas of concern and what to expect in the future. This will be performed by a review of applicable FDA “Strategic Priorities” areas for required review or related industry problem areas.

Each year companies are to perform a complete review of their quality management system and its ability to meet the current GMP’s. The FDA has added a “Strategic Priorities” initiative that can assist companies to proactively address areas of GMP concern. There is a major shift in the emphasis of the U.S. FDA cGMP compliance audits, clinical trial expectations, product submissions and company response requirements.

In short, all regulatory areas are under evaluation by the FDA, and need to be revisited by a company’s QA/RA and its senior management. There is “no business as usual”. This change in focus has a major impact on intrepretation of individual compliance objectives, cGMP objectives, and measurements of success. Ongoing negative publicity on pharmaceuticals, devices, as well as events in unrelated industries show many senior executives just don’t get it, and have put pressure on the Agency to “get tough on compliance / enforcement”. This webinar will trigger such a response by an examination / review of FDA’s “must-have’s” for corporate CGMP compliance

Areas to be Covered:

Mandated Areas for Annual Reviews
The FDA’s “Strategic Priorities” for 2014 and Beyond
Device, Pharmaceutical, Biological and Combination Products Issues
Process validation
Wireless device guidance
The new UDI initiative and counterfitting concerns
cGMP Issues – Strengthened Compliance
The Global Supply Chain
FDA’s Life Cycle Requirements
Navigating through “Better Science”
Expanding “risk based” applications

Who will Benefit:

This is a highly recommended webinar to all regulated companies in reviewing and modifying their regulatory complaince stance. Its principles apply to personnel / companies in the Medical Devices, Pharmaceutical, Diagnostic, and Biologics fields. The employees who will benefit include:
Research & Development
Engineering Staff
Software Department
Quality Assurance
Regulatory Affairs
Manufacturing
Operations
cGMP instructors
Consultants
Mid-level and Senior Management
Personnel involved in verification and/or validation
Personnel involved in planning, execution and documentation

John E. Lincoln

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 of which are as an independent 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 QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis.

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. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.

$299.00

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance