FDAnews Announces: Conducting Advanced Root Cause Analysis CAPA Investigations, Mar. 26-27, 2019, Princeton, NJ
FALLS CHURCH, Va., Jan. 17, 2019 /PRNewswire-PRWeb/ -- Conducting Advanced Root Cause Analysis CAPA Investigations: Critical Thinking Skills and Innovative Techniques to Improve Inspections **Presented by FDAnews and Learning Plus** Mar. 26-27, 2019 ? Princeton, NJ http://www.fdanews.com/capapc
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 Princeton, NJ this December 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.
ompanies 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.
he 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
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.
Conference Details Conducting Advanced Root Cause Analysis CAPA Investigations: Critical Thinking Skills and Innovative Techniques to Improve Inspections **Presented by FDAnews and Learning Plus** Mar. 26-27, 2019 ? Princeton, NJ http://www.fdanews.com/capapc
Tuition: Early Bird Pricing: $1,697 (available until Feb. 26, 2019) Regular Pricing: $1,897 (after Feb. 26, 2019) Significant team discounts are available.
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.
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