Sale Date Ended
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
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 Information- https://www.globalcompliancepanel.com/control/sponsorship
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NetZealous LLC DBA GlobalCompliancePanel
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