USFDA’s 2019 – 2020 Strategic Priorities

This webinar will examine the FDA’s “Strategic Priorities” and related initiatives, with emphasis on 2019-2020. 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.

This reveiw takes on added urgency as a result of the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and what the FDA and industry need to do internally. 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” and related initiatives and areas for required review or related industry problem areas.

The result will be a basis for such a management review and a listing of likely milestones and tasks. Anticipation and addressing of weak spots proactively will further prove a company is “in control”, prepare proactively for and FDA inspection, and assist in timely review of submissions to the Agency, and in any remediation efforts.

Areas Covered in the Session :

  • Mandated Areas for Annual Reviews
  • The FDA’s “Strategic Priorities” for 2019 and Beyond
  • Tougher Regulatory Science — What “Better Science” Really Means
  • Device, Pharmaceutical and Biological Issues
  • General cGMP Issues — Strengthened Compliance
  • 510(k) Issues
  • FDA’s Life Cycle View Requirements
  • Safety / Integrity of Global Supply Chain
  • Heightened Supplier Issues
  • FDA Clearance / Approval Only the Beginning — Product “Lifecycles”
Who Should Attend:

  • Quality Assurance Departments
  • Regulatory Affairs Departments
  • Research and Development Departments
  • Manufacturing Departments
  • Engineering Departments
  • Operations Departments
  • Production Departments
  • Consultants

FDB2781

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.

Refund Policy

membership
  Go PRIME   🛈 $ 240 SELECT
  Personal Plan 🛈 $ 3000 SELECT
  Business Plan 🛈 $ 9000 SELECT
  • 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