Engaged. Knowledge. Application
Complaint Handling CONTENT Package
70 Pages of exclusive "how to" article with bonus material, compliance narrative, SOP template, Checklist and PowerPoint Training Presentation.
➢ 1.Basic Principles of Complaint Handling with Bonus Q andA (Article)
Click here to view complimentary excerpt
➢ 2. Managing the Complaint Handling Process: A Compliance Narrative from a Fictional Company
Click here to view complimentary excerpt
➢ 3.Complaint Handling SOP TEMPLATE
Click here to view complimentary excerpt
➢ 4 Complaint Handling SOP Auditing CHECKLIST
➢ 5.Complaint Handling: An Insider's View of Effective Management Practice (One Hour Webinar Recording)
➢ 6.Complaint Handling: An Insider's View of Effective Management Practice (PowerPoint Training Presentation)
1.Basic Principles of Complaint Handling with Bonus Q and A (Article)
Click here to view complimentary excerpt
A firm's management of their complaint handling process has been a target area of focus by FDA investigators in recent years. This article reviews GMP requirements, written procedures, documentation, common deficiencies noted by FDA investigators, conducting an effective investigation, identifying root cause, assessment of impact, CAPA "rules," trend analysis and preparing for a complaint handling audit.
Includes Bonus Material
A 10 Questions and Answers related to this article are included to test your knowledge retention.
2.Managing the Complaint Handling Process: A Compliance Narrative from a Fictional Company
Click here to view complimentary excerpt
This compliance narrative - an ongoing conversation between one manager and one former employee who rejoins the company - illustrates how one fictional company effectively manages their complaint handling process. Ideal for personnel training, this compliance narrative provides information on how many of the issues presented on our "Basic Principles of Complaint Handling" article are applied. This compliance narrative discusses the following topics, including: Receiving and documenting customer complaints, Medical and Safety assessment of complaints, Quality assurance assessment of complaints, Root Cause investigations, CAPA identification and management, and Trend analysis.
3.Complaint Handling SOP TEMPLATE
This nine (9) page SOP covers major categories including: Complaint Tracking Systems, Medical and QA assessments, receipt, investigations, closeout, CAPA, complaint file documentation, etc.
4. Complaint Handling SOP Auditing CHECKLIST
This six (6) page checklist contains 30 items for verifying that requirements identified in the SOP template for Complaint Handling related to development, implementation and training are correctly implemented.
5. and 6.Complaint Handling: An Insider's View of Effective Management Practice (One Hour Webinar Recording and PowerPoint Training Presentation)
Content: Definition of a Product Complaint, Benefits of a solid complaint handling program, GMP requirements for complaint handling systems, Document requirements for complaints, Current FDA expectations, inspection trends, and example citations, Practical aspects of managing the complaint system during FDA inspections. Instructor: Eldon Henson, Director, Quality for Pharmaceuticals and Research and Development, Covidien (formerly Mallinckrodt)
Complaint Handling CONTENT Package is only $99.00
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