GMP Auditing: 2-Day Workshop
Upcoming

  • Day 1December 3, 2019
    9:00 am - 4:30 pm
  • Day 2December 4, 2019
    9:00 am - 4:30 pm

Location

3550 Pharmacy Avenue, Toronto, Ontario, M1W 3Z3
QA

Certification Areas

Are you interested in becoming an Auditor or wanting to refine your Auditor skills and learn about new trends?  If so, this workshop is just what you need!  Participants can sign up for a single day or both days for best value!

 

The first course is designed for new and beginner auditors who have no or little audit experience. The training will focus on how to prepare for an audit, how to do the audit effectively, how to write the audit report, and how to follow up the audit. The course will discuss the attributes of a good auditor and how to be efficient and effective.

 

The second course is designed for the more experienced auditor and the person who is charged with an entire audit program. The course will describe how to plan, implement and run an entire audit program for both internal and external audits. It will present how to go beyond mere fact finding to making the audits tools for continuous improvement.

 

Day 1- Introductory Level: Are you prepared to be the Auditor?

The 1st part of this workshop is designed for new auditors and will provide an introduction to the GMP auditing process. The training will focus on both internal and external audits including how to: prepare for an audit, perform an audit effectively, write an audit report, and follow up on an audit. The course will also discuss the attributes of a good auditor and ways to be both efficient and effective as an auditor.

 

Outline:

  • Purpose of audits and types of audits
  • Role and requirements of the auditor
  • Planning for the audit including scheduling and logistics
  • Auditing methods, such as interviews, document reviews, and observations
  • Audit tools such as checklists, schedules, interviews
  • Audit standards, GMP regulations, ISO audit standards, ICH Guidelines
  • Conducting the audit
  • Managing an audit team
  • Exit meeting
  • Audit report, follow up and closeout
  • How to get the most from your internal audits
  • How to audit specific suppliers such as contract testing laboratories
  • Case Study: where we present some of the “audited facility issues” and let the attendees participate in preparing together with the instructor, the audit report using what was learned during the course.

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Day 2-  Advanced Level: Auditor, are you prepared to run an audit program?

The objective of this course is for the more experienced auditor and the person who is charged with the entire audit program.  The course describes how to plan, implement and run an entire audit program for both internal and external audits.  It will present how to go beyond mere fact finding to making the making the audit tools for continuous improvement.

 

Outline:

  • Brief review of
    • Purpose of audits and types of audits
    • Role and requirements of the auditor
    • Planning for the audit including scheduling and logistics
    • Auditing methods, such as interviews, document reviews, and observations
    • Audit tools such as checklists, schedules, interviews
  • Audit standards, GMP regulations, ISO audit standards, ICH Guidelines
  • Managing a pool of auditors and large audit teams
  • Audit report, how to include continuous improvement
  • How to get the most from your internal audits, especially across multiple sites or departments
  • Use your audit to improve practices, e.g. gap analysis against lean procedures or statistical process control
  • How to audit specific suppliers such as contract testing laboratories
  • Brief discussion of auditing data integrity
  • Brief discussion of auditing Quality by Design programs
  • Examples of FDA warning letters
  • Impact of audits from FDA risk analysis program
  • Case study: hands-on part portion with respect to plan, implement and run an entire audit program
  • This course will also include breakout sessions in which the participants apply what they have learned

 

SPEAKER: Jane Weitzel

Jane Weitzel has been working in analytical chemistry for over 40 years for pharmaceutical and mining companies.  She is currently a consultant specializing in laboratory management systems and ISO/IEC 17025, an auditor, and an educator. Jane has applied Quality Systems and statistical techniques, including the evaluation and use of measurement uncertainty, in a wide variety of technical and scientific businesses. She has obtained the American Society for Quality Certification for both Quality Engineer and Quality Manager.

 

For the 2010 – 2015 cycle, Jane was a member of the USP Reference Standards committee and Expert Panel on Method Validation and Verification. In 2014 she was pointed to the Chinese National Drug Reference Standards Committee and attended their inaugural meeting in Beijing. Jane is a member of the USP’s Expert Committee on Statistics and the Expert Panel on Method Validation and Verification For the 2015 – 2020 cycle.

 



Basic Member Single Day Ticket: $650.00 On Sale
Student Ticket: $450.00 On Sale
Basic Member 2-Day Ticket: $1100.00 On Sale
2-Day Group Ticket (5+): $1000.00 On Sale
Pro/Pro Plus Member Single Day Ticket: $575.00 On Sale
Pro/Pro Plus Member 2-Day Ticket: $1025.00 On Sale