Navigation Links
FDAnews Announces: Early Bird Pricing Ends Sept. 22 for Conducting Advanced Root Cause Analysis CAPA Investigations, Oct. 23-24, 2017, Arlington, VA
Date:9/15/2017

Conducting Advanced Root Cause Analysis CAPA Investigations:
Understanding Advanced Critical Thinking Skills and Innovative Techniques to Improve the Quality of Investigations
**Presented by FDAnews and Learning Plus**
Oct. 23-24, 2017 – Arlington, VA
http://www.fdanews.com/capapc

Early bird pricing for Conducting Advanced Root Cause Analysis CAPA Investigations ends on Friday, Sept. 22.

The greatest threat to compliance is ... overconfidence.

Take CAPA. Manufacturers may think they have it down pat. But CAPA failures show up year after year in about half of all warning letters.

Come to Arlington, VA this October for two days of intense CAPA training sponsored by FDAnews.

Under the guidance of a nationally recognized CAPA expert, attendees will discover new paths to improved CAPA compliance, dispel mystifying myths and misunderstandings and set themselves up for better relations with the FDA and global regulators too.

  • The FDA is continually enforcing CAPA requirements? Get up to speed on key regulatory requirements both at home and abroad.
  • Companies may be great at getting CAPA procedures in place, yet fail when it comes to executing them? Here’s how to clear away those barriers.
  • The too-often-neglected process of properly opening and closing CAPAs can trigger warning letters? Get the big picture and gain start-to-finish discipline.

The CAPA coach, Jim Vesper, has guided thousands of individuals through the maze called CAPA. With more than 25 years of experience in GMP and investigation training, he’s seen every problem and answered every question you may have.

Come ready to work, hard. It’s a tough schedule — two full days of intensive training.

The payoff? A wealth of practical knowledge, tips, tools and techniques to put into effect right away. Here’s just a taste of what attendees will discover:

  • Regulators’ expectations regarding investigations, CAPAs and investigation reports
  • How to use accident/incident models when conducting investigations
  • Six different accident/incident models and what sets each one apart
  • Root cause, contributing cause, proximal cause: Clarifying confusion
  • Why ‘human error’ is not a valid root cause
  • Relationship of root/contributing/proximal causes to corrections/corrective actions
  • A model to illustrate multiple layers of control and mitigation
  • The four audiences of investigation reports: What each expects manufacturers to show
  • The sections of an investigation report: What each must include
  • What to do when a definitive root cause cannot be identified
  • Investigation report with deficiencies: Ways to improve
  • And much more!

This course comes with a ton of valuable working materials — charts, guides, reading lists, FDA regs/guidances/manuals, recent Forms 483 with pitfalls to avoid. Early bird pricing ends on Friday, Sept. 22.

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 FDAnews and Learning Plus**
Oct. 23-24, 2017 – Arlington, VA
http://www.fdanews.com/capapc

Tuition:
Early Bird Pricing: $1,697 (available until Sept. 22, 2017)
Regular Pricing: $1,897 (after Sept. 22, 2017)
Significant team discounts are available.

Easy Ways to Register
Online: http://www.fdanews.com/capapc
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/CAPAoctober2017/prweb14670208.htm.


'/>"/>
Source: PRWeb
Copyright©2017 Vocus, Inc.
All rights reserved


Related medicine news :

1. FDAnews Management Report: Managing Contract Manufacturers and Testing Labs
2. FDAnews Management Report: Implementing Risk-Based Verification and Validation
3. FDAnews Announces CDRH’s Office of Compliance Reorganization: A “One-On-One” with Office Director Steve Silverman, Webinar, Feb. 5, 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 — Improving Your FDA Import Success Rate: Tips for Thinking Ahead of the FDAWebinar, Aug. 7, 2014
6. FDAnews Announces — Choosing the Right Drug Name: How to Increase Your Chances for Approval Webinar, July 22, 2014
7. FDAnews Announces — New Job Board Now Available on FDAnews.com
8. FDAnews Workshop: Conducting Advanced Root Cause Analysis CAPA Investigations, Sept. 17-18, 2014, Raleigh, NC
9. FDAnews New Workshop, 2 Weeks to Register — Innovative Process Validation Strategies for Medical Devices, Aug. 26-27, 2014, Bethesda, MD
10. FDAnews Announces Choosing the Best Device Sample Size for Verification and Validation: Tools to Safely Speed Your Device to Market, On-Demand Webinar, Aug. 27, 2014
11. FDAnews Announces — What to Do Now for UDI: Don’t Lose Your Customers by Getting Locked Out of the Market Webinar, Sept. 9, 2014
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/15/2018)... ... August 15, 2018 , ... Trumpet Behavioral Health (“Trumpet”) ... editor of Behavior Analysis in Practice, one of the leading journals in the ... and research officer for Trumpet, leading the company’s research clinical standards and training ...
(Date:8/14/2018)... ... , ... Health & hygiene ranked eighth out of 15 industries ... of brands based on emotions. In the U.S., Olay again topped the industry, followed ... & hygiene industry were: Listerine, Nivea, Gillette, Colgate, Head & Shoulders, Pantene and Crest. ...
(Date:8/11/2018)... ... August 10, 2018 , ... Dr. Siavash Eftekhari, Oral and Maxillofacial ... for a week-long international outpost trip to deliver dental care in impoverished communities. Along ... staff, Dr. Eftekhari volunteered his time to help deliver care to over 550 individuals ...
(Date:8/11/2018)... ... August 11, 2018 , ... Financial Voyages LLC CEO ... Executive of the Year-Business category in The 15th Annual International Business Awards®. , ... and organizations worldwide – public and private, for-profit and non-profit, large and small ...
(Date:8/9/2018)... ... August 09, 2018 , ... ... outcomes by simplifying medication adherence monitoring with Smart-pill bottle and mobile applications, ... in the App Orchard. , The DoseSmart medication management and medication adherence ...
Breaking Medicine News(10 mins):
(Date:8/11/2018)... ... 10, 2018 , ... Dry eye solutions® on line appear to be plentiful, ... they do provide some relief from dry eye disease, yet none of them provide ... by a small company in tiny Grants Pass, Oregon. That dry eye solution® is ...
(Date:8/9/2018)... ... 09, 2018 , ... Autism is a developmental disorder affecting more than 3.5 ... (approximately 1 in 68 people have the disorder), chances are you know someone on ... a child with autism methods of communication and tactics to interact with others. These ...
(Date:8/7/2018)... ... August 06, 2018 , ... ... disease in Clinton, MS using laser dentistry techniques. Using their BIOLASE WaterLase® ... laser gum therapy called REPAIR Perio™. , Affecting the lives of millions of ...
Breaking Medicine Technology: