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Course offering number:0909-703

Course ID:
2309
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Introduction to cGMP System-Based Audits
In Conjunction with Wiley-Blackwell
 Pre-recorded Course
AN ON-DEMAND ONLINE TRAINING FORMAT

Who Should Attend
This introductory online presentation will benefit professionals in the pharmaceutical, medical device and related industries who are responsible for GMP compliance issues. The course will be of great interest to newly assigned auditors or those who expect to be involved in auditing in the near future. It can also be used as a refresher course for more experienced auditors.

The material presented will be very beneficial to professionals in the following areas:

  • Management responsible for the audit function
  • QA/QC
  • Regulatory
  • Vendors and suppliers to these industries
  • Laboratory
  • Production
  • Packaging

Description
Auditing is a major management tool to ensure compliance with regulations and standards. The need for GMP system-based audits is a worldwide requirement at all stages, starting with active pharmaceutical ingredient (API) , bulk pharmaceuticals, finished pharmaceuticals, medical device, biologics etc. This 90-minute accredited training course provides an introduction to the major regulations and standards requiring the existence of an audit function in companies. It details the beginning stages for setting up a system-based audit program and concludes with a few examples of check points during drug and device system-based audits.

Module 1: Requirements for system-based audit programs as identified in:
  • QSR – Quality System Regulation for medical device
  • FDA Guidance for Pharmaceutical Quality Systems
  • Q7A – GMP for Active Pharmaceutical Ingredients
  • ICH Q10 – Pharmaceutical Quality System
  • Quality System Standards – ISO 9000 and 13485

Module 2: Getting started
  • Audit classification
  • Audit manual/procedures
  • The audit cycle
  • Audit master plan

Module 3: Is your company in compliance?
  • Following the ten commandments of cGMP
  • Check points during drug GMP system-based audits
  • Check points during device GMP system-based audits
  • Examples of Warning Letters

Question and Answer Session


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