Showing posts with label audit. Show all posts
Showing posts with label audit. Show all posts

Tuesday, June 25, 2013

FDA Considers New Quality Metrics


FDA Seeking Industry Input on Quality Metrics to Help Rationalize Its Review and Inspection System | IPQ Newsletter:

"Based on its review of all the responses submitted on the metrics issue, FDA has chosen three that it is considering using and is seeking additional feedback on:
  • batch failure rate
  • right first time, and
  • out-of-specification (OOS)/laboratory failure investigation rates"
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SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around



Tuesday, January 31, 2012

Auditing: Internal and External Customers and Suppliers - Onsite GMP & QSR Class

Updated October 29, 2022

The "Auditing" course is no longer available.

You might also be interested in:

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Auditing: Internal and External Customers and Suppliers - is a live on-site cGMP and QSR class by SkillsPlus International Inc.  This training is delivered as an in-house class taught at the client's location.

Purpose:
This class teaches students how to:
  • apply an auditing model that applies to a wide-variety of situations
  • qualify suppliers, to assure that they meet your specifications and appropriate GMPs
Objectives:
Upon class completion, students will be able to:
  1. State the regulatory requirements for audits. 
  2. Identify common reactions to the audit process. 
  3. Manage adverse reactions to audits. 
  4. Plan an efficient and thorough audit. 
  5. Apply the Quality System inspection approach for audit planning. 
  6. Review relevant regulations applicable to the audit area. 
  7. Gather evidence of compliance/noncompliance. 
  8. Report results to affect change and build relationships. 
  9. Manage the corrective action and preventive action process
Topics covered in class include:
  • Managing audits
  • Pre-audit questionnaire
  • Audit focus
  • Gathering evidence
  • Ratings
  • Auditing report
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Tuesday, November 15, 2011

Batch Record Review Training - a live cGMP class

Updated August 17, 2022

The batch record review course is no longer available.

You might also be interested in our other cgmp online training programs and courses.

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GMP Training - Batch Record Reviewing - cGMP Training

Learn how to review batch records to identify errors and issues.

Faster Product Release Through Efficient Batch Record Review is a live training class. Upon course completion, students will be able to:
  1. State the source of batch record requirements for both US and EU 
  2. Distinguish between the production and QA batch record review 
  3. List best practices in Batch Record Review 
  4. Demonstrate at least 5 different batch record review activities
In-house projects will be used to demonstrate and practice the skills and principles of this class.

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