enKap community

Engaged. Knowledge. Application

CAPA Training Package

Package includes one webinar recording with powerpoint presentation and two bonus blogs:

➢ 1.CAPA: Implementing an Effective Program: Lessons from the Trenches (One Hour Webinar Recording)

➢ 2.CAPA: Implementing an Effective Program: Lessons from the Trenches (PowerPoint Training Presentation)

➢ 3.Guidelines for CAPA Scoping (Bonus Blog)

➢ 4.When Does an Organization Need to Open a CAPA?(Bonus Blog)

1. & 2. CAPA: Implementing an Effective Program: Lessons from the Trenches (One Hour Webinar Recording & 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

3. Guidelines for CAPA Scoping - BLOG

by William McQuillan, Jr. former Global Manager, Change Document and Records Management, Cordis, a Johnson & Johnson Company

4. When Does an Organization Need to Open a CAPA? - BLOG

by William McQuillan, Jr. former Global Manager, Change Document and Records Management, Cordis, a Johnson & Johnson Company


Comment

You need to be a member of enKap community to add comments!

Join enKap community

Contact enKap

Phone: +1-561-308-3093

To e-mail enKap - click here

Members

enKap Terms and Conditions

enKap Terms and Conditions

All sales are final

Legal Disclaimer

This product and any of its enclosures, attachments or appendices, references to online information, conferences or preparations of materials in a variety of formats are created to provide you with accurate and authorative information concerning the subject matter covered. However, this product and any other ancillary items disseminated in connec-
tion with same are not necessarily prepared by a person licensed to practice law in a particular jurisdiction.
enKap, Inc. is not engaged in rendering legal advice, and this product is not a substitute for the advice of an attorney. If you require legal or other expert advice, you should seek
the services of a competent attorney or other professional.
enKap, Inc. necessarily is not, cannot and will not be liable for any claims, damages, or regulatory legal proceedings initiated as a consequence of you, the customer, modifying,
altering, adding to or deleting portions of any product initially provided by enKap, Inc.
Once any original document provided by enKap, Inc. to you, whether in print or electronic format, has been manipulated or customized by you, then the responsibility for the
document’s accuracy, correctness, and compliance are solely yours.
If any action, claim for damages, or regulatory proceedings is commenced against enKap, Inc. as a consequence of your alteration or modification, etc. of the document templates
or other originally provided materials, then and in that event, you agree to indemnify enKap, Inc. for such claims, and for any attorney’s fees expended by enKap, Inc. in connec-
tion with defense of same.

© copyright 2012 enKap

© 2012   Created by enKap.

Badges  |  Report an Issue  |  Terms of Service