Root Cause Analysis: Foundation of Investigations and CAPA

Start Date : May 17, 2018
End Date : May 17, 2018
Time : 9:00 am to5:00 pm

Phone : (800) 447-9407
Email : support@globalcompliancepanel.com

Location :
DoubleTree by Hilton Philadelphia Airport 4509 Island Avenue, Philadelphia, PA 19153

Website

Description


Course “Root Cause Analysis: Foundation of Investigations and CAPA” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Overview:

Why you should attend:


Who will benefit:

This seminar will be of benefit to anyone working in a GMP regulated environment on global or domestic scale within the pharmaceutical and medical device industry. This includes quality, validation, engineering, manufacturing, and management personnel from sponsors and contract manufacturers (CMO) alike. This is anyone who wants to improve their ability to solve recurring problems should attend this training. Additionally, those who are actively involved in performing, overseeing, auditing, or managing investigations will find this course extremely beneficial.

Agenda:

 

Day 1 Schedule


Lecture 1:

Regulatory Expectations for Investigations


Lecture 2:

What is RCA and Typical Problems


Lecture 3:

Investigation Process Overview


Lecture 4:

Skills and Tools of an Effective Investigator


Lecture 5:

(Re) Introduction to Root Cause Analysis (RCA)

STEP 1 – Problem Definition

STEP 2 – Understanding the Process

STEP 3 – Identifying Possible Causes


Lecture 6:

Defining the Deviation

FDA Enforcement Actions and Industry Trends 

Day 2 Schedule


Lecture 1:

Identifying Root Cause

STEP 4 – Data Collection

STEP 5 – Data Analysis


Lecture 2:

Corrective and Preventive Actions (CAPA)


Lecture 3:

Management of the Investigation


Lecture 4:

Members of the Investigation Team


Lecture 5:

Consulting Case Study Practice – Incident/Events


Lecture 6:

Case Study Practice

FDA Enforcement Actions and Trends


Lecture 7:

Interactive Exercises and Discussions


Questions and Summary 

Speaker

David R. Dills

Global Regulatory Affairs & Compliance Consultant and President, NovaQual 

David R. Dills, Global Regulatory Affairs & Compliance Consultant, Interim President, currently provides global regulatory affairs, compliance and quality consultative services for early-stage and established Class I/II/III medical device, including combination products, In Vitro Diagnostics, nutraceuticals/supplements, cosmetics and biopharmaceutical manufacturers in multiple medical specialties and therapeutic areas on the global landscape, and has an accomplished record with more than 26 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by medical device manufacturers and consultancies, including a globally recognized CRO and has worked directly with manufacturers engaged in compliance remediation activities and services involving consent decrees, CIA’s, warning letters,483 observations, and customer generated compliance events, and prepares for and conducts QS and regulatoryaudits. He is currently acting and interim President at NovaQual LLC.

 

Location:  Philadelphia Date: May 16th & 17th, 2018 and Time: 9:00 AM to 5:00 PM

Venue:  WILL BE ANNOUNCED SOON

Price:

Price: $1,295.00 (Seminar Fee for One Delegate)

Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*

Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)*

 Register now and save $200. (Early Bird)

Until April 20, Early Bird Price: $1,295.00 From April 21 to May 14, Regular Price: $1,495.00

Sponsorship Program benefits for “Root Cause Analysis: Foundation of Investigations and CAPA” seminar

For More Informationhttps://www.globalcompliancepanel.com/control/sponsorship 

Contact us today!

NetZealous LLC DBA GlobalCompliancePanel

john.robinson@globalcompliancepanel.com  

support@globalcompliancepanel.com 

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

 Website: http://www.globalcompliancepanel.com

 

Registration Link – https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901735SEMINAR?SEO

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Registration Info

Registration link :   https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901735SEMINAR?may-2018-seo-meetings4doc

Contact the Organizer

Organized by

Organized by globalcompliancepanel

NetZealous LLC DBA GlobalCompliancePanel ,
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.

GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient.

Tel: 800-447-9407
Email: support@globalcompliancepanel.com
Website: https://www.globalcompliancepanel.com/


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