FDA Inspectional and Regulatory Enforcement Trends: Key Focus on Trends in Consent Decree

This training program is designed for people tasked with developing, maintaining and improving environmental monitoring programs for non-sterile manufacturing facilities. It will focus on current Food and Drug Administration (FDA) regulatory guidance as well as current regulatory trends pertaining to consent decree.

Why Should You Attend:

In the recent past there has been an explosion of regulatory enforcement specifically involving consent decree. This webinar will focus on key quality systems that are being highlighted in many of the consent decrees, such as Computer Systems Validation focusing on 21CFR Part 11, Electronic Records and Signatures (ERES), Equipment Qualification, Change Control Systems, Proper Laboratory Investigations, Corrective Action/Preventative Actions (CAPA), Root Cause Analysis (RCA), etc.

Who Will Benefit:

This course will benefit individuals that have quality management systems responsibilities for making general improvements in their organization’s performance specifically related to microbial control of the manufacturing environment. Following personnel will benefit from the course:

Quality Assurance

Quality Control

Regulatory Compliance

Validation

Information Technology (IT)

Instructor Profile:

Gaurav Walia, M.S., is a pharmaceutical consultant – consent decree/computer systems validation. He has most recently worked on three major consent decree projects with McNeil/Johnson & Johnson (CSV), Novartis (third party manufacturing assessment), and b. Braun (CSV, overall QA and compliance, audits). Overall, Mr. Walia has over 19+ years of pharmaceutical experience with careers at Monsanto/Searle, Pfizer/Oread, Forest Laboratories, etc., while also serving as a pharmaceutical consultant in various disciplines from quality systems, consent decree, computer systems validation, etc.

Note:

Use coupon code NB5SQH8N and get 10% off on registration, Valid till Dec 31st 2015.

For Registration:

http://www.complianceonline.com/fda-inspectional-and-regulatory-enforcement-focus-on-trends-in-consent-decree-webinar-training-704321-prdw?channel=sciencedz