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Live Corporate Seminar

International Seminar on Corrective And Preventive Action In FDA Regulated Industry

insert_invitation Thursday, 12th October, 2017
access_time 09:00 AM - 01:00 PM EST |
timelapse with 30 mins of Q and A

Note:

Post session, copy of presentation slides will be shared

Speaker/Presenter

Jeff Kasoff, RAC, CQM/OE

Quality and Regulatory Affairs

Consultant

Short Abstract

The objective of this course is to provide the tools you need to develop and implement a compliant and effective CAPA system, from clear understanding of regulatory requirements to accurate root cause determination to confirmation of CAPA effectiveness.

The session will focus on uderstanding CAPA and will discuss about the Elements of a Corrective Action Program


Apply for this Seminar

Program Agenda

8:30 AM – 09:00 AM Spot Registration + Breakfast + Introduction
09:00 AM - 09:30 AM Understanding CAPA :
  • Review of Regulations
  • Definitions
  • Where/When is CAPA Required
09:30 AM - 10:00 AM Tea/Coffee Break
10:00 AM - 11:00 PM Elements of a Corrective Action Program :
  • Essential SOPs and Other Documentation
  • Detection of nonconformance
  • Identification of cause (Investigation)
  • Review of Investigation
  • Determination of Corrective/Preventive Action
  • Performance of Corrective Action
  • Implementation of Corrective Action
  • Effectiveness of Corrective Action
  • Common Misconceptions
11:00 AM - 11:30 AM Root Cause Analysis
Sources of, and The application of risk management to a CAPA program
11:30 AM - 12:30 PM How FDA Trains its Investigators to Review CAPA, and Recommended Compliance Methods
Fun and Games with CAPA: A Mini-Workshop
12:30 PM - 01:00 PM Q&A – Conclusion
01:00 PM - 02:00 PM Lunch

Registration Information

  • Registration Fee : USD $499
  • For assistance on registration, please send an email to marketing@biopractice.com or Please call: Ph - 1-646-216-8860
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