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 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
Mid-level and Senior Management
Personnel involved in verification and/or validation
Personnel involved in planning, execution and documentation