GMP Auditing 2-Day Workshop in Winnipeg
Expired

  • Day 1March 21, 2018
    9:00 am - 4:00 pm
  • Day 2March 22, 2018
    9:00 am - 4:00 pm

Location

1000 Waverely Street, Boardroom 103, Winnipeg, Manitoba, Canada, R3T 0P3
M M QA QC

Certification Areas

SEAT SALE! RESERVE YOUR SPOT NOW!!

 

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!

 

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.

 

Key topics to be discussed:

  • *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
  • *Practical breakout session where Attendees can apply what they have learned

 

Day 2- Advanced Level: Are You Prepared to Run an Audit Program?

This course is tailored for more experienced auditors, professionals that are in charge of an entire audit program and also for the attendees of the introductory level workshop which was scheduled earlier this year. The course will describe how to plan, implement and run an entire audit program for both internal and external audits.  It will describe how to go beyond mere fact finding, making the audit tools for continuous improvement.  To conclude the course, attendees will have the opportunity to apply what was learned during the case study session of the workshop.

This course will cover the following topics:

  • *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
  • *Examples of FDA warning letters
  • *Impact of FDA audits in India

This course is ideal for:

  • *QA Auditors, QA Managers, Auditors of suppliers and contractors, Operations and manufacturing personnel,  QC Managers and staff
  • *Professionals who get audited will also benefit from this course to learn more about the auditing plan process.
  • *Note that attendees of the introductory level workshop will benefit attending this advanced level course.

 

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.



Single Day Non-Member Ticket: $525.00 Sold Out
Single Day Pro/Pro Plus Member Ticket: $495.00 Sold Out
2-Day Non-Member Ticket: $890.00 Sold Out
2-Day Pro/Pro Plus Member Ticket: $840.00 Sold Out