ONLINE TRAINING 2016 - Maintaining an Effective CAPA Program and Using Risk Assessment Tools: Current Trends - By AtoZ Compliance

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Category CAPA Program , capa training, risk assessment tools, FMEA training, failure mode effect analysis

Deadline: March 15, 2016 | Date: March 15, 2016

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

Updated: 2016-02-10 14:37:58 (GMT+9)

Call For Papers - CFP

Get an overview on the current trends in identifying recommended practices to improve, streamline, refine, retool, develop, deploy and maintain a viable and sustainable CAPA system.

Overview

CAPA programs are critical for any manufacturer. FDA considers your program the immune system for your site business unit and determines how healthy or unhealthy you are. Industry is now using various risk-based approaches and tools to set-up, deploy and maintain their CAPA training to help with the decision making process.

Why Should You Attend

This webinar provides an overview on identifying recommended practices to improve, streamline, refine, retool and develop, deploy and maintain a viable and sustainable CAPA system.

Learn that a well written policy and procedure on setting up and maintaining your system is just the first part of the process, now you need to monitor your system because CAPA is your immune system and will determine how healthy or unhealthy or business site is.

Areas Covered In This Webinar

Understand the emphasis on analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other risk assessment tools and quality problems and the use of appropriate statistical methodology where necessary to detect recurring quality problems.

Learning Objectives

How to use FMEA training effectively and calculating Risk Priority Numbers: How to use the criteria

How to facilitate a product complaint investigation as part of your CAPA program

What is a closed-loop investigation…cradle to grave approach

How to conduct an investigation using a well-written CAPA policy and failure mode effect analysis

Understand and comprehend what FDA is looking for in meeting minimum expectations…no band-aid solutions

Why risk assessment and risk-based approaches, FMEA, FTA, HACCP, etc., are now the expectation in terms of good business practice

Establish a priority system as related to major versus minor or high risk versus low risk classifications…to support your decisions

Develop and deploy escalation rules and criteria to facilitate decision-making process

Understand what it takes to conduct a “quality” investigation to ascertain the root cause

Review and discuss recent CAPA red flags and FDA enforcement actions

Who Will Benefit

All levels of Management for all Departments

QA/QC/CAPA Coordinators

CAPA Specialists

Regulatory Affairs and Compliance Professionals

Engineering/Technical Services/Operations Personnel

Consultants

Speakers Profile

David R Dills

David R. Dills, is an independent Global Regulatory Affairs & Compliance Consultant and has an accomplished record with more than 26 years of experience in regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVD's, and bio/pharmaceutical manufacturers on the global landscape.

Previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO, has worked directly with and for manufacturers engaged in compliance remediation activities involving consent decrees, CIA’s, FDA warning letters, and customer generated compliance events, provides Strategic GxP Compliance and Regulatory Consulting, handles all aspects of global regulatory submissions and dossiers, including 510(k), PMA and IDE submissions, serves as a U.S. Agent, works with stakeholders and Center Reviewers regarding submission meetings/negotiations, clinical affairs, and provides regulatory submissions and post-market project leadership/guidance covering different therapeutic and medical specialties based on classification. Background encompasses broad capabilities in regulatory and compliance oversight and governance, regulatory and GxP training, and compliance with MEDDEV/MDD/IVDD Directives.

Mr. Dills leads and manages efforts involving multi-country product registrations and licensing in Asia Pacific, EU and The Americas from premarketing to postmarketing, and works with the Regulatory Authorities and strives to provide consistent, practical compliance solutions that work with reduction of regulatory compliance risk.

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