CAPA CONTENT Power Package

This training information resource package contains 12 content elements which help ensure that your company meets FDA requirements. It includes three webinar recordings, three powerpoint presentations, over 50 pages of exclusive "how to" articles, SOP Template, two checklists, and form:

➢ 1.and 2. FDA CAPA Inspections: A Primer for Successful Execution (One Hour Webinar Recording and PDF PowerPoint Training Presentation)

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➢ 3. and 4. CAPA: Implementing an Effective Program: Lessons from the Trenches (One Hour Webinar Recording and PDF PowerPoint Training Presentation)

➢ 5. and 6. CAPA: Datastream Analysis (One Hour Webinar Recording and PDF PowerPoint Training Presentation)

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➢ 7. A Guide to Effective Management Practice - Part I: CAPA Basics (Article)

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➢ 8. A Guide to Effective Management Practice - Part II: Datastream Analysis for Identifying CAPA Items (Article)

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➢ 9. CAPA SOP TEMPLATE

➢ 10. CAPA SOP Auditing CHECKLIST

➢ 11. Audit Checklist for CAPA - with 50 items!

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➢ 12. Failure Investigation and CAPA Implementation FORM

1. and 2. FDA CAPA Inspections: A Primer for Successful Execution(One Hour Webinar Recording & PDF PowerPoint Training Presentation)

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Webinar instructor William McQuillan, Jr. former Global Manager, Change Document and Records Management, Cordis, a Johnson & Johnson Company, reviews the following subject matter content below:

➢ Preparing for an Inspection

-File preparation

-Staging room setup

➢Managing an FDA Inspection

-CAPA owner preparation

-Information flow

-Time management

➢FDA inspection Areas of Focus:

-CAPA initiation

-CAPA timelines

-CAPA effectiveness

-Appropriate responses during the inspection

➢FDA inspection trends

➢Benefits of compliance to CFR 820 Subpart J

3. and 4. CAPA: Implementing an Effective Program: Lessons from the Trenches (One Hour Webinar Recording & PDF PowerPoint Training Presentation)

Webinar instructor William McQuillan, Jr. former Global Manager, Change Document and Records Management, Cordis, a Johnson & Johnson Company, reviews the following subject matter content below:

➢Definition of a CAPA

➢Benefits of an effective CAPA program

➢GMP requirements for CAPA systems

➢Examples of clearly defined roles and responsibilities

➢Understanding CAPA inputs

➢CAPA process overview

➢Risk evaluation

➢CAPA scoping and file evaluation

➢Conducting a product-focused investigation

➢Review and approval

➢Implementation

➢Effectiveness monitoring

➢Current FDA CAPA expectations

➢CAPA system management

5. and 6. CAPA: Datastream Analysis (One Hour Webinar Recording and PDF PowerPoint Training Presentation)

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➢Importance of CAPA systems

Regulatory requirements

Role in a comprehensive quality system

Results expected from a well-functioning CAPA system

➢Datastream analysis

What is it?

Why is it required?

How does it differ from an Annual Product Review?

➢What data should be included in a comprehensive datastream analysis?

Complaint trends

Failure investigations

OOS investigations

Rejections, reprocessing and rework

Nonconformances, deviations and exceptions

Change control

Product returns

Internal audit results

Service records

Any other quality-related metrics

➢How should data be organized or presented?

Pareto

Pie charts

Trend charts

Histograms

Bottom line… trends

➢How are trigger points established for a CAPA from a datastream analysis?

Historical results

Statistical analysis

Critical to quality results

➢Application of risk management principles to datastream analysis

Which trends reveal true concerns?

Using quality risk management to prioritize

➢Output of datastream analyses

When to initiate a CAPA

CAPA investigations

Monitoring effectiveness

➢Approaches for communicating results of datastream analysis

Breadth of communication

Management review

➢Case studies on datastream analysis for CAPA

Complaint trend example – product odors

Complaint trend example – thick tablets

Analytical result example

7. A Guide to Effective Management Practice - Part I: CAPA Basics (Article)

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A high percentage of Warning Letters issued by FDA in recent years includes citations for ineffective or deficient CAPA systems. In this article, you will learn the basic GMP requirements for CAPA, and how an effective CAPA system can result in significant product and process improvements in your company's operations. Subject matter includes the following: Defining CAPA, Identification of negative trends through periodic analysis, Process improvement initiatives, which include examples of CAPA, Root Cause, Why CAPA actions should be SMART (includes chart for easy reference, FDA expectations and much more. Plus....

Bonus Material

10 Questions and Answers related to this article are included to test your knowledge retention.

8. A Guide to Effective Management Practice - Part II: Datastream Analysis for Identifying CAPA Items (Article)

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A must read article for implementing datastream analysis-a key element of an effective CAPA system. In Part II of this article, CAPA basics are first reviewed. Then the three basics elements that result in permanent corrective/preventive actions are discussed: (1.) Reaction to unplanned or unexpected events. (2.) Identification of negative trends through periodic analysis. (3.) Process improvement initiatives.

Root cause, GMP requirements, FDA expectations, identification of root cause, effective CAPA management, execution of CAPA action items, documentation requirements, effectiveness checks and management oversight are also reviewed. Several charts for easy reference are also included in this article.

Bonus Material

17 Questions and Answers related to this article are included to test your knowledge retention.

9. CAPA SOP TEMPLATE

The purpose of this ten (10) page procedure is to define general and specific requirements for the identification, initiation, management, control, monitoring, closure and oversight for the Corrective And Preventive Action (CAPA) system.

10. CAPA SOP Auditing CHECKLIST

This six (6) page checklist contains 26 items for verifying that requirements identified in the SOP template for CAPA related to development, implementation and training are correctly implemented.

11. Audit Checklist for CAPA - with 50 items!

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12. Failure Investigation and CAPA Implementation FORM

This five (5) page form includes 9 critical areas including: general information, define: issue description; measure: summary of investigation; analyze: analysis of investigational data and ID of root cause; analyze: impact on company systems and processes; risk management; innovative improvement: action items and implementation plan; control: baseline and effectiveness monitoring.

CAPA CONTENT Power Package is only 159.00