| Starts: | Thursday November 05, 2009 at 8:30am |
|---|---|
| Ends: | Friday November 06, 2009 at 5:00pm |
| Event Type: | Training/Seminar |
| Region: | Greater Los Angeles Area |
| Location: |
Marriott Bayview 500 Bayview Circle Newport Beach, CA 92660 US |
| Price: | $1000 |
| Website: | http://shop.pathwise.com/product.sc?productId=3 |
| Industry: | medical device |
| Keywords: | Life Science, Issue Review, Regulatory, Compliance, Corrective Action, Preventive Action, Corrective And Prevent, Capa Training, Training, Medical Device, Fda, Workshop, Pharmaceutical, Investigations, Quality Systems, Audit, Preparation, California, Orange County |
| Intended For: | regulatory, compliance, investigators, laboratory, QA/RA functions, managers, manufacturing supervisors, technicians, and engineers. |
| Organization: | PathWise, Inc. |
COURSE OVERVIEW
This course is designed to meet the requirements mandated by the FDA to effectively locate root causes and correct them. The CAPA workshop teaches proper identification of non-conformances (problems), how to assess and prioritize them based on risk, and how to implement a proper corrective and/or preventive action.
The course teaches the following key process skills:
Issue Review - Identify and prioritize non-conformances based on risk.
Root Cause Analysis - Investigate systemic issues for underlying cause.
Implementation & Effectiveness Checking - Solution selection, verify and validate, implement, monitor and confirm success.
LEARNING OBJECTIVES
Throughout the workshop, attendees improve their ability to:
Gather relevant information on problems through specific, focused questioning.
Pinpoint root causes using facts instead of guesswork or opinion.
Avoid costly experiments and trial fixes by logically testing possible causes.
Assess and prioritize each nonconformance based on risk.
Target potential problems before they happen and develop actions to prevent them.
Effectively involve other people in the investigation process (i.e. when, and only when needed).
Check effectiveness of corrective actions. Document their analysis in an easy-to-use format.
AUDIENCE
CAPA is appropriate for individuals who are regularly called upon to resolve problems, or whose input would aid in preventing problems. Examples include investigators, laboratory, QA/RA functions, managers, manufacturing supervisors, technicians, and engineers.
This course will not only focus on CAPA, but on how to conduct investigations including non-conformances, customer complaints, out of specifications, or any other investigations you may face within your organization.
SPEAKERS
Nathan Conover Sr. Partner PathWise
- Additional speakers to include compliance experts from local regulatory bodies.
LOCATION
Marriott Bayview Newport Beach, CA
COST
$1000 - Includes Breakfast, Lunch & Materials
AGENDA
Day One - November 5, 2009
8:30 a.m. - Registration & Breakfast 9:00 a.m. - Opening Remarks 9:30 a.m. - Issue Review 12:30 p.m. - Lunch 1:30 p.m. - Root Cause Analysis 4:30 p.m. - Q&A Discussion 5:00 p.m. - End of Day One
Day Two - November 6, 2009
8:30 a.m. - Breakfast 9:00 a.m. - CAPA Implementation 12:00 p.m. - Lunch 1:00 p.m. - Effectiveness Checking 3:00 p.m. - Regulatory Body General Session 4:00 p.m. - Regulatory Body Panel Discussion 4:30 p.m. - Q&A Discussion