U.S. FDA’s Strategic Priorities – 2016 and Beyond

This webinar will discuss about the “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. Major 510(k) changes will be discussed, as will the new combination products CFRs and Pharma requirements.

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 Covered in the Session : 

• Major “Drivers” and New U.S. FDA Initiatives
• The FDA’s “Strategic Priorities” for the period until 2018
• Major foreseeable problem areas for 2016 and beyond
• Device, Pharmaceutical, Biological and Combination Products Issues
• cGMP Issues – Strengthened Compliance
• Major and Pending 510(k) Changes
• 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
• Expanding “risk based” applications

Who Should Attend:

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

Course Director: 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.