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Achieving Compliance with Robust
CAPA Systems
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Instructor Profile:
In order to solve problems every organization
must know how to conduct an effective
investigation, identify root causes, and
implement workable corrective action in a timely
manner. An effective CAPA process requires
training internal investigators, who can also
coach others in the organization, to employ
critical thinking. The process must provide a
common model and language within the
organization, which allows investigators to
master the process quickly and easily.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Description:
In order to solve problems every organization must
know how to conduct an effective investigation,
identify root causes, and implement workable
corrective action in a timely manner. An effective
CAPA process requires training internal
investigators, who can also coach others in the
organization, to employ critical thinking. The
process must provide a common model and
language within the organization, which allows
investigators to master the process quickly and
easily.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Objectives of the Presentation:
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
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Areas 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
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Who can Benefit:
Quality Control Personnel & Management
Manufacturing Personnel & Management
Senior Management
Regulatory Affairs Personnel & Management
Quality Assurance Personnel & Management
Supplier Quality Personnel & Management
Track this Link:
Compliance With Robust CAPA
Systems
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

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Achieving compliance with robust capa systems

  • 1. Achieving Compliance with Robust CAPA Systems www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
  • 2. Instructor Profile: In order to solve problems every organization must know how to conduct an effective investigation, identify root causes, and implement workable corrective action in a timely manner. An effective CAPA process requires training internal investigators, who can also coach others in the organization, to employ critical thinking. The process must provide a common model and language within the organization, which allows investigators to master the process quickly and easily. www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
  • 3. Description: In order to solve problems every organization must know how to conduct an effective investigation, identify root causes, and implement workable corrective action in a timely manner. An effective CAPA process requires training internal investigators, who can also coach others in the organization, to employ critical thinking. The process must provide a common model and language within the organization, which allows investigators to master the process quickly and easily. www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
  • 4. Objectives of the Presentation: 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 www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
  • 5. Areas 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 www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
  • 6. Who can Benefit: Quality Control Personnel & Management Manufacturing Personnel & Management Senior Management Regulatory Affairs Personnel & Management Quality Assurance Personnel & Management Supplier Quality Personnel & Management Track this Link: Compliance With Robust CAPA Systems www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com