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CAPA/ROOT CAUSE ANALYSIS: ACHIEVING COMPLIANCE WITH PROPER CAPA SYSTEMS

By: Danielle DeLucy

16 February, 2023 (Thursday)

Duration: 90 Minutes

Timing: 12:00 PM PST | 03:00 PM EST

Countdown:

 * 9 : Days
 * 01 : Hrs
 * 07 : Min
 * 10 Sec

 * OVERVIEW
 * AREA COVERED
 * LEARNING OBJECTIVES
 * WHO WILL BENEFIT?

This webinar will include discussions on proper CAPA system maintenance, root
cause analysis, documentation of the Corrective and Preventative Actions, and
developing a robust CAPA plan. It will give tips on how to develop CAPAs
pertaining to longer-term projects and ensure they stay on track.

AREA COVERED

Definition of a CAPA:

 * When a CAPA is needed
 * Development of the essential pieces of a robust CAPA plan

Root Cause Analysis Methods:

 * Discussion of different Root Cause Analysis methods and benefits of each

Establishment of the CAPA Plan:

 * Project Summary development
 * Responsibilities of individuals involved
 * Establishing Completion Dates
 * Creating meaningful effectiveness checks

Management of the CAPA System:

 * Maintaining proper documentation of the CAPA plans
 * Ensuring CAPA plans are progressing
 * Proper close-out of CAPA plans

LEARNING OBJECTIVES

 * Discuss what to do when problems occur
 * Outline the requirements of the CAPA process and procedure including building
   a CAPA file
 * Choose the most appropriate Root Cause Analysis methods for the situation
 * Establishing a CAPA plan: project summary, individual responsibilities, and
   expected completion dates
 * Management and Oversight of the CAPA system and its documentation

WHO WILL BENEFIT?

 * Quality Control Personnel & Management
 * Manufacturing Personnel & Management
 * Senior Management
 * Regulatory Affairs Personnel & Management
 * Quality Assurance Personnel & Management
 * Supplier Quality Personnel & Management



Definition of a CAPA:

 * When a CAPA is needed
 * Development of the essential pieces of a robust CAPA plan

Root Cause Analysis Methods:

 * Discussion of different Root Cause Analysis methods and benefits of each

Establishment of the CAPA Plan:

 * Project Summary development
 * Responsibilities of individuals involved
 * Establishing Completion Dates
 * Creating meaningful effectiveness checks

Management of the CAPA System:

 * Maintaining proper documentation of the CAPA plans
 * Ensuring CAPA plans are progressing
 * Proper close-out of CAPA plans

 * Discuss what to do when problems occur
 * Outline the requirements of the CAPA process and procedure including building
   a CAPA file
 * Choose the most appropriate Root Cause Analysis methods for the situation
 * Establishing a CAPA plan: project summary, individual responsibilities, and
   expected completion dates
 * Management and Oversight of the CAPA system and its documentation

 * Quality Control Personnel & Management
 * Manufacturing Personnel & Management
 * Senior Management
 * Regulatory Affairs Personnel & Management
 * Quality Assurance Personnel & Management
 * Supplier Quality Personnel & Management

  Download Brochure   Set Email Reminder



Live Webinar Options:
(Live Session for 1 Participant)
Live Session ($199)


INCREASE PARTICIPANTS

1 Participants $199 2 Participants $299 3 Participants $399 4 Participants $449
5 Participants $499 6 Participants $549 7 Participants $599
(Live + Recorded Session)
Super Jumbo Offer ($269)
(Live + Transcript)
Live + Transcript ($249)
(Live + Training CD)
Super Jumbo Offer ($450)
On Demand Options:
(PDF Transcript of Training)
Transcript ($179)
(Downloadable Recorded session)
Recorded session ($239)
(Training CD)
Training CD ($350)
Group Session Options:
(Group Session Participants + Recorded)
Group Session for 10 Participants($799)

For adding extra attendees please contact our Customer Support Team


$


For multiple location please contact our customer care team Tel:+1-661-336-9555

Feb. 7, 2023

Marketing to Medicare or Medicaid Beneficiaries - What You Can and Cannot Do

William Mack Copeland

SPEAKER PROFILE



Danielle DeLucy
View All Webinars

Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides
Pharmaceutical and Biologics based companies with training and quality systems
assistance in order to meet Regulatory compliance. Prior to this role, Danielle
has been in the industry for 15 years serving in numerous Quality Management
Roles, such as the Director of Product Quality, the oversight of Sterility
Assurance practices and provided QA oversight of numerous filling and packaging
operations. Danielle began her QA career as a Quality Control Pharmaceutical
Microbiologist at a contract laboratory where she performed various tests for
their clients. In the years after, she has held positions in the Quality
management arena while increasing her responsibility. She has helped to lead
many Regulatory Health Inspections and was instrumental in the coaching process
of her peers prior to any inspection. Currently, Danielle assists companies who
are faced with warning letters, consent decrees and those wishing to improve
compliance establish more robust quality systems so that the company can
succeed. 
 



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