U.S. FDA’s Strategic Priorities – 2015 and Beyond

$299.00

Description:

This webinar will discuss about two “Strategic Priorities” that the FDA has published to emphasize their future directions vis a vis regulated industry and public safety.

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 are now two such reports – we will discuss both, emphasizing the latest “draft for public comment”, for 2014 – 2018. The reports reflect 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 / staff.

This change in focus has a major impact on interpretation 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 stated concerns for corporate cGMP compliance and public safety

Areas to be Covered:

Major “Drivers” and New U.S. FDA Initiatives
The FDA’s “Strategic Priorities” (1): 2011 – 2014
The FDA’s “Strategic Priorities” (2): 2014 – 2018
Major foreseeable problem areas for 2015 and beyond
Device, Pharmaceutical, Biological and Combination Products Issues
cGMP Issues – Strengthened Compliance
The Global Supply Chain
FDA’s Life Cycle Requirements
Navigating through “Better Science”
A company gap analysis vis a vis FDA priorities
Correcting problem-prone areas
Interactive Q & A session

Who will Benefit:

This webinar will provide valuable assistance to all U. S. FDA-regulated companies. It will assist in their reviewing and modifying their regulatory compliance stance in view of the areas the FDA indicates are of growing / future interest / emphasis. 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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  • 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