Webinar On U.S. FDA's Strategic Priorities - 2015 and Beyond

Event Details

Time: January 21, 2015 from 1pm to 2:30pm
Location: Online
Street: 5939 Candlebrook Court
City/Town: Mississauga
Website or Map: https://compliancetrainings.c…
Phone: 4169154458
Event Type: webinar
Organized By: Compliance Trainings
Latest Activity: Dec 2, 2014

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Event 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 Covered in the Session :

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