Navigation Links
FDAnews Workshop: Conducting Advanced Root Cause Analysis CAPA Investigations, Sept. 17-18, 2014, Raleigh, NC
Date:7/30/2014

Falls Church, VA (PRWEB) July 30, 2014

Conducting Advanced Root Cause Analysis CAPA Investigations
Understanding Advanced Critical Thinking Skills and Innovative Techniques to Improve the Quality of Investigations
**Presented by Immel Resources and FDAnews**
Sept. 17-18, 2014 – Raleigh, NC
http://www.fdanews.com/CAPAWorkshopRaleigh

CAPA has been the #1 reason for 483 observations since 1997.

The FDA's enforcement plan makes it clear: Developing a successful CAPA program has never been more important.

But creating an FDA-proof CAPA isn’t easy.

If only drug and devicemakers could pick the brain of someone who is coping successfully with CAPA, the best and the brightest, an industry leader who has devised programs, procedures and solutions that have put companies out in front with the FDA.

Well, they can.

FDAnews and Immel Resources are offering an advanced version of their previous CAPA investigations class — fully updated to meet tough FDA scrutiny in 2014.

In this year’s Conducting Advanced Root Cause Analysis and CAPA Investigations workshop, attendees will:

  • Learn how to respond to the FDA and implement effective CAPAs to prevent regulatory action and get a closeout letter.
  • Get an insider’s view of the FDA's own training program for investigators, with portions of the Reid Technique DVD reviewed during the course.
  • Discuss lessons learned from nine years of FDA warning letter citations on CAPA investigations.
  • Learn key problem-solving techniques to break a problem down into its component parts: CIA, Kepner-Tregoe and FMEA.
  • Receive a course workbook complete with charts, forms, manuals and guidance.
  • Interact with colleagues during 8 exercises.

Additional benefits attendees will receive by attending Conducting Advanced Root Cause Analysis and CAPA Investigations include:

  • Gain valuable strategies for performing in-depth interviews and determining individuals responsible for an event.
  • Discover best practices for training, assigning and managing your lead investigators, using proven law enforcement techniques.
  • Benchmark current best practices in CAPA and investigations with your peers.
  • Learn 22 great investigative tools you can teach to all your employees.
  • Obtain sample forms for conducting investigations and case reviews.
  • Review required FDA notifications, such as field alerts, medical device reports, biologic product deviation reports, adverse events, serious adverse events, recalls, corrections and removals.
  • Understand the four elements of a well-written report and how to coach employees on report writing.

Who Will Benefit:

  • CAPA manager
  • QA/QC managers and director
  • Compliance officer
  • Training manager
  • GCP, GLP or GMP professional    
  • Regulatory affairs manager
  • Quality engineer
  • Anyone wishing to improve an organization's CAPA activities and investigations

The Expert Instructor:
Barbara K. Immel, a published author and nationally known speaker, is president of Immel Resources LLC and editor of the Immel Report. She has 30 years of industry experience working in corporate quality assurance, compliance, training, documentation and labeling. Barb’s experience includes more than 12 years with Syva Company, Chiron Corporation and Syntex Corporation. Barb is the chairperson of the Annual FDA Inspections Summit hosted by FDAnews and a member of the steering committee for FDA MedCon 2010, Xavier University’s new medical device conference. Barb has been teaching well-respected courses on writing reports for deviations and failure investigations, and on conducting CAPA investigations, for the past 13 years (2000–2013).

Conference Details
Conducting Advanced Root Cause Analysis CAPA Investigations
Understanding Advanced Critical Thinking Skills and Innovative Techniques to Improve the Quality of Investigations
**Presented by Immel Resources and FDAnews**
Sept. 17-18, 2014 – Raleigh, NC
http://www.fdanews.com/CAPAWorkshopRaleigh

Tuition: $1,897
Significant team discounts are available.

Easy Ways to Register
Online: http://www.fdanews.com/CAPAWorkshopRaleigh
By phone: 888-838-5578 or 703-538-7600

About FDAnews
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

Read the full story at http://www.prweb.com/releases/FDAnews/CAPAWorkshopRaleigh/prweb12060492.htm.


'/>"/>
Source: PRWeb
Copyright©2014 Vocus, Inc.
All rights reserved

Related medicine news :

1. FDAnews Announces — New Job Board Now Available on FDAnews.com
2. FDAnews Announces — Choosing the Right Drug Name: How to Increase Your Chances for Approval Webinar, July 22, 2014
3. FDAnews Announces — Improving Your FDA Import Success Rate: Tips for Thinking Ahead of the FDAWebinar, Aug. 7, 2014
4. FDAnews Announces Device Software Verification and Validation: Get Ready for a New Breed of Investigators, On-Demand Webinar, Aug. 12, 2014
5. FDAnews Announces CDRH’s Office of Compliance Reorganization: A “One-On-One” with Office Director Steve Silverman, Webinar, Feb. 5, 2014
6. FDAnews Management Report: Implementing Risk-Based Verification and Validation
7. FDAnews Management Report: Managing Contract Manufacturers and Testing Labs
8. FDAnews Announces The FDA Unique Device Identification (UDI) Rule Virtual Conference
9. oBand Centers Conducting Weight Loss Requirement Evaluation at No Extra Cost
10. Extended-Car-Warranty.com Awards CARCHEX with the 2013 Gold Award after Conducting Reviews of Extended Auto Warranty Companies
11. Michigan Head & Neck Institute is Conducting a School Supplies Drive at Their Facility to Benefit Local Year-Round Elementary School Students
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/20/2019)... ... March 20, 2019 , ... VirtuOx, http://virtuox.net/ , a ... to diagnose cardiac arrhythmias in the patient’s home. , The VirtuOx CardioCHECK program ... cardiac telemetry (MCT) in the convenience and comfort of the patient’s home. , ...
(Date:3/20/2019)... ... 20, 2019 , ... Nike Softball Camp SUNY Cobleskill will be ... camp with her staff. , Coach Slupinski takes the reigns of the SUNY Cobleskill ... head coach for 2 seasons. Slupinski had an impressive playing career for the University ...
(Date:3/20/2019)... ANGELES (PRWEB) , ... March 20, 2019 , ... AutismOne ... from fiction in the current debate over measles. Dr. Wakefield's presentation at the AutismOne ... regard to both the pre-vaccine and vaccine eras. The lecture will examine the consequences ...
(Date:3/20/2019)... ... March 20, 2019 , ... Adam Equipment, a leading ... H77 at Forum Labo Paris from 26-28 March at Paris expo Porte de Versailles ... and the Solis series of balances. Both balance lines include models that ...
(Date:3/20/2019)... , ... March 20, 2019 , ... Caring.com, the nation’s ... top medical alert systems for 2019. The medical alert provider was recognized as the ... companies that qualified for the list based on its demonstration of excellent customer service, ...
Breaking Medicine News(10 mins):
(Date:3/20/2019)... SAN RAFAEL, Calif. (PRWEB) , ... March 20, 2019 , ... ... High School and will be directed by Rick Swan, the head volleyball coach at ... in the state, which means that players from the Rocky Mountain area now have ...
(Date:3/20/2019)... ... 2019 , ... On World Oral Health Day, Mercy Ships recognizes ... dedication to the oral health of patients in Africa. Dr. Ugai heads up the ... standards of care within African partner healthcare institutions. , Dr. Ugai is currently ...
(Date:3/19/2019)... ... 19, 2019 , ... AltaPointe Health is taking part in ... Independent for Life (SAIL). At the core of the SAIL program is the ... stay active and reduce their chances of falling. , Twenty-three AltaPointe staff ...
Breaking Medicine Technology: