Online Safety Community

Root Cause Analysis to Meet FDA Expectations - 2017

Event Details

Root Cause Analysis to Meet FDA Expectations - 2017

Time: May 24, 2017 from 10am to 11am
Location: Online
Street: 161 Mission Falls Lane, Suite 216,
City/Town: Fremont
Website or Map: http://www.compliance4all.com…
Phone: 18004479407
Event Type: webinar
Organized By: Adam Fleaming
Latest Activity: Mar 22

Export to Outlook or iCal (.ics)

Event Description

Overview:  
Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities, the basic foundation of a viable CAPA system.

Why should you Attend:
A valid closed-loop CAPA system requires defined failure investigation including systemic root cause analysis for true problem (not symptom) resolution. Growing high-profile field problems indicate that such effective and repeatable failure investigation and root cause analysis is still not the industry norm.

Areas Covered in the Session:
Regulatory "Hot Buttons"
The 4 Basic Steps to Problem Solving
A Suggested Investigation Template

Who Will Benefit:
Senior management in Drugs, Devices, Biologics, Dietary Supplements
QA
RA
R&D
Engineering
Production
Operations

Speaker Profile:
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com

Comment Wall

Comment

RSVP for Root Cause Analysis to Meet FDA Expectations - 2017 to add comments!

Join Online Safety Community

Attending (1)

Take our poll!

Take our poll!

Latest Activity

Profile IconMOHAMMAD RAHMAN, Siva, Tim Sheehan and 5 more joined Online Safety Community
2 hours ago
kate smith posted a blog post

Understanding the Importance of Drafting the Employee Handbook Rightly

Employee handbooks are a great way for organizations to state their policies vis-à-vis employee behavior. On the one hand, they are a simple and reliable guide to letting employees and other people connected to the organization in one or another way about many aspects of the organization’s culture. On the other, employee…See More
7 hours ago
John Robinson posted a blog post

Implementing ICH guidelines-compliant validation

Professionals in the field of statistical analysis need to possess clarity on understanding and interpreting statistical concepts used to investigate quantitative ICH Guidelines, such as:Analytical methods validationProcedures and acceptance criteria in calibration limits…See More
8 hours ago
Adam Fleaming posted a blog post

How to Comply and how to Protect Privacy

The General Data Protection Regulation (GDPR) –codified as Regulation (EU) 2016/679 – is an important law concerning the protection of data of all people living in the European Union (EU). Through the GDPR regulation; all the legislative and secretarial bodies of the EU, namely the European Parliament, the Council of the European Union and the European Commission, fortify and toughen and unify all aspects of…See More
9 hours ago

Forum

What is Class Structure in Pega?

Class contains the rule by way of which objects behave. outline rules such as houses, sports, flows, html paperwork, etc. to be had to different subordinate classes. lessons are organized into a…Continue

Started by Soujanya Naganuri Jul 17.

How to Concatenate Two Tables in QlikView

Table combining and concatenationConcatenate appends the rows of one table to another. Concatenate never merges any rows. The number of rows in a concatenated table is always the sum of the rows of…Continue

Tags: datafields, developers, qlikview

Started by Soujanya Naganuri Jun 30.

SQL Server Windows Management Instrumentation Tasks

Hello,SSIS includes two special tasks that enable you to query system information and monitor system events: the WMI Data Reader Task and the WMI Event Watcher Task. These tasks are especially useful…Continue

Tags: Task, WMI, Server, SQL

Started by Madison Quinn Jun 20.

difference between NEBOSH and IOSH

NEBOSH “National Examination Board in Occupational Health and Safety”IOSH “Institution…Continue

Tags: kerala, IGC, NEBOSH

Started by mani May 31.

What's your favorite motivational/safety quote? 98 Replies

Favorite Motivational Quote: If you want something, you'll find a way - If not, you'll find an excuse.Favorite Safety Quote: Don't learn safety by accident!Continue

Started by Michelle Sears. Last reply by David R Snell Apr 26.

Badge

Loading…

© 2017   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service