ONLINE TRAINING 2016 - FDA / EU Inspections - Getting Prepared - By Compliance Global Inc.

Website https://complianceglobal.us/product/700264/MarieDorat/fda-eu-inspections-getting-prepared/1 | Edit Freely

Category FDA regulations training, EU regulations, good clinical practice training, form 483 fda, EMEA inspection, FDA audit training

Deadline: January 07, 2016 | Date: January 07, 2016

Venue/Country: New Hyde Park, U.S.A

Updated: 2015-12-03 16:01:49 (GMT+9)

Call For Papers - CFP

Marie Dorat, CQA,CAA is a QA/RA compliance, GxP Training and International product registration Consultant in the Pharmaceutical/Medical Device & IVD Industry She also is the CEO of IPRF, LLC which specializes in helping established and start-up companies process the necessary documents for international product distribution.

Ms. Dorat has 13 years’ experience in quality assurance and regulatory affairs in the pharmaceutical/Medical Device & IVD industry, including auditing clinical trials, manufacturers, and distributors in the US and internationally. She has held a number of senior QA/RA positions. She has worked for several companies including Pfizer, and Alere She has lectured at conferences and provides on-site training courses on QA and GxP issues.

She has also worked directly with various companies in the Pharmaceutical & Medical Device industry, assisting with international new product registrations as well as rebranding products after an acquisition or merger. She has developed a process to reduce time to market for most companies by several months. She provides training courses both for public groups and in-house on topics including: International Product Registration project management, Auditing 101, Writing and managing Quality Systems, GCP , Regulatory requirements for Clinical Trials, FDA audit and EU inspection- How to Prepare.

Overview

This webinar is a comparative look at FDA & EU regulations to help attendees understand the FDA and EU inspection process and how to prepare for both of them. Attendees will learn the best practices to respond to Form 483 citations, Warning Letters and EU inspection findings.

Why Should You Attend

FDA regulations training and EU regulations and standards apply for pharmaceuticals, biologics and medical devices. Failure to conform to these good clinical practice training may result in concerns about quality and integrity. Inspections are critical to the success of business on several levels. Therefore, being appropriately prepared and management of the inspection and audit process are critical activities. The consequences if a company does not pass an inspection are time consuming, delayed product approvals, and could lead to civil or even criminal litigation by the FDA and EU inspection agencies.

This webinar has been specifically designed to help attendees prepare for FDA and EU inspection. It will provide a background and understanding of the role played by the regulatory inspectors, and the administrative and enforcement powers. Attendees will be taken through the key stages of FDA and EU inspection processes and understands the various types of inspections that can be carried out.

Areas Covered in this Webinar

Differences between FDA and EU inspections including the FDA and EU joint inspection programmer

How to prepare for EMA and FDA audit training

How to plan for an audit or inspection using checklists/ FDA/EMEA inspection guidelines

Tips for employees before the inspect

Tips on proper responses to prepare for audit/inspection interviews

Setting up a triage to ensure that required documents are available

How to interact with the inspectors?DOs and DON’Ts

How to reply to inspection reports, form 483 fda’s and EU inspection finding

Post inspection actions ? implementing appropriate CAPAs in response to audit findings

Learning Objectives

What to expect during an FDA/EU inspection

How to be prepared ? with special focus on GCP inspections

Who Will Benefit

Quality Assurance Managers and Auditors

Regulatory Affairs Personnel

Document Management Professionals

Other Professionals who want to know more about inspection guidelines

Level

Beginner

For more detail please click on this below link

https://complianceglobal.us/product/700264/MarieDorat/fda-eu-inspections-getting-prepared/1

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