Engaged. Knowledge. Application
FDA Compliance Digest - September 2010 Table of Contents
***CLICK ON ARTICLE TITLE TO VIEW EXCERPT - Note: Not all articles have excerpts***
➢Subpart F – Production and Process Controls: Meeting GMP Requirements
➢Subpart F – Production and Process Controls PowerPoint Training Presentation and Trainer Instructional Notes
➢FDA For Cause Inspection – A Compliance Narrative From a Fictional Drug Company: Part II-Answering the 483
➢Subpart G – Packaging and Labeling Control: Meeting GMP Requirements
➢Subpart G – Packaging and Labeling Control PowerPoint Training Presentation and Trainer Instructional Notes
➢Conducting Internal Audits SOP
-Audit Report Template
➢Managing Effective Nonclinical QA Programs: Part II
➢Clinical Trial Protocols: An Introduction
➢Change Control Audit Checklist
➢Software Supplier Audit Tool Creation Checklist
➢Batch Production Records – GMP Considerations: An Introduction
➢Batch Record Review SOP
-Attachment 1: Batch Record Review Checklist
-Attachment 2: Quality Disposition Form
➢Conducting Effective Batch Record Review PowerPoint Training Presentation and Trainer Instructional Notes
➢Subscribe Now in our enKap Store
***CLICK HERE to view the FDA Compliance DIgest SAMPLE ISSUE***
➢Current Issue: Table of Content and Article Excerpts (click here)
➢Individual Articles (click here)
Contact enKap
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.
